Reported trial results for HIV and AIDS

207 trials have reported results.

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

• NCT05057858 · results posted 15 June 2026

  According to the results reported on ClinicalTrials.gov, this trial enrolled 72 women across four groups of 18 each. Three groups were non-pregnant women randomly assigned to take a HIV prevention pill (known as oral PrEP, containing two medicines called tenofovir and emtricitabine) either 2, 4, or 7 times per week over eight weeks — representing poor, moderate, or perfect adherence to the dosing schedule. The fourth group consisted of pregnant women who also took the medication. The trial was measuring how much of the active drug ingredients built up in participants' blood at different dosing levels, using two types of blood samples: dried blood spots (a simple finger-prick card) and a type of blood cell called peripheral blood mononuclear cells (PBMCs — white blood cells that can be tested for drug levels). The reported data shows that drug levels in the dried blood spots after eight weeks were 359 units (fmol/punch) in the poor adherence group, 749 in the moderate adherence group, 1,389 in the perfect adherence group, and 799 in the pregnant group. Similarly, in the white blood cell samples, the tenofovir-related drug levels were 7.4, 31.2, 59.8, and 49.6 units (fmol per million cells) for poor, moderate, perfect adherence, and pregnant groups respectively. For the second medicine (emtricitabine-related levels) in white blood cells, the reported figures were 483, 2,099, 5,431, and 5,587 units across those same groups. Notably, the emtricitabine component could not be reliably detected in dried blood spot samples for many participants — particularly those taking fewer doses — so those results were not reported. A separate set of mathematically modelled ("fitted") steady-state drug level estimates from dried blood spots were also reported: 416, 832, 1,457, and 895 units for poor, moderate, perfect adherence, and pregnant groups respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT06307028 · results posted 28 April 2026

  According to the results reported on ClinicalTrials.gov, this trial involved 23 participants, all of whom were Black women considered potentially eligible for PrEP (a medication taken to reduce the chances of getting HIV). The trial was testing a programme called SISTA-P, and its main focus was not on whether the programme prevented HIV, but rather on whether the programme itself was practical to run, acceptable to participants, and felt appropriate for the group it was designed for. Of the 23 people who started, 22 completed the study and 1 did not. The reported data shows that participants were asked to rate the programme across several areas using a scale from 1 (strongly disagree) to 5 (strongly agree). For how feasible — that is, how practical and workable — the programme seemed, the average score reported was 4.78 out of 5. For acceptability (how agreeable or welcome the programme felt), the average score was 4.72 out of 5. For appropriateness (how well-suited the programme felt for their situation), the average score was 4.83 out of 5. Participants were also asked about their intentions to use PrEP within the next 12 months, and the average score on that same 1–5 scale was reported as 3.85. The reported data also shows that all 23 enrolled participants were potentially PrEP-eligible Black women, which the researchers had set as a target. The trial originally aimed to enrol 8–12 people per programme cycle, but the researchers adjusted this to smaller groups of 5–8 participants during the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03670316 · results posted 15 April 2026

  According to the results reported on ClinicalTrials.gov, this trial (NCT03670316) enrolled 371 people who smoked — 185 in a group receiving an "Algorithm Treatment" (AT), which appears to be a structured, computer-guided approach to quitting smoking, and 186 in a group receiving "Enhanced Treatment as Usual" (eTAU), a more standard care approach. The trial measured whether people had stopped smoking in the seven days before their follow-up check, as well as several other related measures such as how many cigarettes people smoked per day, whether they tried to go without smoking for at least 24 hours, and how many received a prescription for a quit-smoking medicine. By the end of the study, 134 people in the AT group and 131 in the eTAU group completed the trial. The reported data shows that, for the primary measure — whether participants had not smoked in the past seven days — 16 people in the AT group and 12 people in the eTAU group reported not smoking, while 110 in the AT group and 114 in the eTAU group reported that they had smoked. For the secondary measures, the reported average number of cigarettes smoked per day was 9 in the AT group and 10 in the eTAU group. Regarding 24-hour quit attempts at six months, the data shows two sets of figures — 61 and 68 participants in the AT group, and 72 and 61 in the eTAU group — though the distinction between these two sets of numbers was not fully explained in the submitted data. For prescriptions written by six months, 109 participants in the AT group and 33 in the eTAU group were reported as having received a prescription. It is worth noting that the reported data does not include some details that would help fully interpret these numbers, such as at what time point the primary outcome was measured or what the two separate figures for 24-hour quit attempts represent — these were not explained in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT06582966 · results posted 13 April 2026

  According to the results reported on ClinicalTrials.gov, this trial enrolled 60 participants in a single study group called "DoxyDOT Single Arm." The trial was looking at a dosing approach called doxyPEP — a form of the antibiotic doxycycline taken after potential exposure to certain sexually transmitted infections — given under direct observation (meaning a health worker watched participants take each dose). The study tracked how consistently participants took their weekly doses over the course of the trial, and also collected surveys about how acceptable the approach was to participants. Of the 60 people who started, 56 completed the study and 4 did not. The reported data shows that across all participants over the full study period, a total of 1,417 doses were recorded as taken. This figure represents the combined count of all weekly observed doses confirmed and logged by study staff. No other numerical results — such as survey scores on acceptability or any comparison figures — were included in the structured data submitted to ClinicalTrials.gov, so those details cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01818791 · results posted 11 March 2026

  According to the results reported on ClinicalTrials.gov, this trial involved 909 young people across two groups. One group of 433 participants received a programme called "Making Proud Choices" on its own, while the other group of 476 participants received "Making Proud Choices" combined with an additional support framework called "Getting To Outcomes." The trial was measuring attitudes about abstinence, as well as staff capacity and how closely the programmes were delivered as intended. Of those who started, 275 in the first group and 305 in the second group completed the study. The reported data shows that attitudes about abstinence were measured using a five-point scale, where a higher number meant more favourable attitudes toward abstinence. Two sets of scores appear to have been recorded, likely at different points in time. For the "Making Proud Choices Alone" group, the reported scores were 4.18 and then 4.17. For the "Making Proud Choices + Getting To Outcomes" group, the reported scores were 4.17 and then 4.26. All four scores sit close together near the top of the scale. For the two secondary outcome measures — staff capacity to run the programme and how faithfully the programme was delivered — no numerical results were reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT06503991 · results posted 2 February 2026

  According to the results reported on ClinicalTrials.gov, this trial (NCT06503991) enrolled 100 adults who took part in a program called the COACH Intervention, which involved community health worker (CHW) counselling sessions, doctor's visits, and phone calls over six months. The study was designed to look at how practical and workable (feasible) this program was, and to gather information on blood pressure control, medication habits, and knowledge about high blood pressure. Of the 100 people who started, 96 completed the study and 4 did not. The reported data shows that across all 100 participants, a total of 589 scheduled sessions — including counselling appointments, doctor's visits, and phone calls — were attended over the six-month period. This was the main thing the study set out to measure. For the secondary measures, the reported data shows that at the six-month mark, 91 out of 100 participants reported that they were taking their blood pressure medication as prescribed. Separately, 73 out of 100 participants had blood pressure readings that fell within a controlled range (defined in the study as a top number below 140 and a bottom number below 90). Participants also completed a knowledge quiz about high blood pressure (scored out of 22), and the reported average score at six months was 20.4 out of 22, where a higher score means greater knowledge. It is worth noting that this trial had only one group — everyone received the COACH Intervention — so these numbers reflect that single group only, and there was no separate comparison group reported in the data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT06029712 · results posted 31 December 2025

  According to the results reported on ClinicalTrials.gov, this trial enrolled 35 people in total — 17 in one group and 18 in the other. It was a crossover study, meaning everyone tried both approaches at different times: taking heart failure medicines as separate individual tablets, and taking them combined into a single "polypill." The trial was measuring whether people were more likely to take their medicines consistently with one format compared to the other, using pill counts and questionnaires. The reported data shows that when medicines were taken as a polypill, the overall pill-count adherence score was 83.3%, compared to 74.6% when taken as individual tablets. On a self-reported questionnaire about medication-taking habits (the MMAS-8, scored 0–8 where higher means better), participants scored 4.6 with the polypill and 4.1 with individual tablets — both falling in the "low adherence" range (below 6) on that scale. Treatment satisfaction (scored 0–100, higher meaning more satisfied) was reported as 73.6 points for the polypill and 69.0 for individual tablets. When the researchers looked at adherence broken down by each type of medicine within the combination, the polypill figures were consistently higher across all four medicine categories, ranging from roughly 80–84%, compared to roughly 71–74% for individual tablets. The reported data also shows that scores on a heart-failure quality-of-life questionnaire (KCCQ-12, scored 0–100) were 70.6 for the polypill period and 67.9 for the individual tablets period. Regarding hospital admissions for heart failure during the study, zero were recorded in the individual-tablets group and one in the polypill group. The trial was described as a small pilot study, so it was not designed to draw firm conclusions from these admission numbers. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02591420 · results posted 17 December 2025

  According to the results reported on ClinicalTrials.gov, this trial enrolled 24 people in total — 8 in each of three groups. All three groups had recently acquired HIV. One group received immediate antiretroviral treatment (ART, the standard HIV medication) plus a dummy (placebo) infusion; a second group received immediate ART plus infusions of an antibody called VRC01; and a third group received VRC01 infusions first, with ART starting a short time later. The trial was measuring things like changes in the amount of HIV in the blood, how long it took for the virus to reach very low levels, and whether the VRC01 infusions were associated with any serious side effects. Of the 24 who started, 21 completed the study — all 8 in Group 1, 7 in Group 2, and 6 in Group 3. The reported data shows that for the two groups who started ART straight away, the amount of HIV in the blood (measured on a scientific scale called log copies/mL) dropped by about 1.52 units (Group 1, placebo) and 1.61 units (Group 2, VRC01) over the first seven days. In the group that received VRC01 without immediate ART, the drop over the same period was smaller, at about 0.23 units. The reported data also shows that the median time for the virus to reach a very low level (under 50 copies per millilitre of blood) was 58 days in Group 1, 43.5 days in Group 2, and 87 days in Group 3. Regarding serious side effects possibly linked to the VRC01 antibody infusion, zero participants in Groups 1 and 2 experienced a grade 3 or higher event considered related to the antibody, while 1 participant in Group 3 did — where grade 3 means a severe reaction on a standard medical severity scale. The reported data also includes a range of additional measurements of HIV levels in the blood and in cells at multiple time points up to 24 weeks, with figures varying across the three groups throughout the study period. These numbers are technical and complex, and their full meaning would need to be considered carefully in context. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT06487390 · results posted 9 December 2025

  According to the results reported on ClinicalTrials.gov, this pilot trial (NCT06487390) enrolled 46 healthcare providers who took part in a programme called "PrEP Pro" — a training intervention designed to support providers in offering HIV prevention medication (PrEP) and related sexual health care. Of the 46 who started, 32 completed the study, and 14 did not finish. The trial was primarily measuring whether the programme was practical to run (feasibility) and whether participants found it acceptable, using simple rating scales scored from 1 to 5. The reported data shows that on the feasibility scale, participants gave an average score of 4.28 out of 5, and on the acceptability scale, an average score of 4.31 out of 5 — where higher scores indicate greater feasibility and acceptability respectively. For the secondary measures, the reported data shows that at the time surveyed, 18.75% of participants answered all five HIV knowledge questions correctly. On the sexual history practices scale (scored 1–3), reported subscale averages were 2.5 for attitudes, 3.0 for skills, 3.0 for barriers, and 2.7 for training-related items. For PrEP-related knowledge and attitudes, the reported scores were 16 out of 20 for knowledge, 26 out of 28 for attitudes, and 6 out of 8 for beliefs. Regarding STI screening practices, the reported data shows that 90.63% of providers said they assessed sexual history for adolescent girls and young women at least some of the time, compared with 56.25% for adolescent boys and young men; and 71.88% reported testing girls and young women for STIs at least some of the time, compared with 34.38% for boys and young men. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05540652 · results posted 19 November 2025

  According to the results reported on ClinicalTrials.gov, this trial tested a program called Mindfulness-Based Queer Resilience (MBQR), an online mindfulness program designed for queer (LGBTQ+) people. The main goal was not to test whether the program "worked" in a medical sense, but rather to find out whether it was *feasible* (that is, could it be run practically — could researchers recruit and keep participants?) and *acceptable* (did participants find it satisfactory?). A total of 19 people enrolled in the program. The reported data shows that 19 participants started the program and 18 completed it, with 1 person not finishing. On average, participants attended the live sessions for about 5.84 weeks and completed the at-home practice activities for about 5.32 weeks out of the program's total weeks. For satisfaction, participants filled in two questionnaires. On the Client Satisfaction Questionnaire (an 8-question survey scored from 8 to 32, where higher scores mean greater satisfaction), the reported average score was 26.17 out of 32. On a separate Session Evaluation Form (scored from 10 to 40, where *lower* scores mean greater satisfaction), the reported average score was 16.17 out of 40. It is worth noting that this was a small, single-group study with no comparison group, and its stated purpose was to gather early information about how the program could be run and received — not to draw broader conclusions. The reported data shows the numbers above only; no claims about health outcomes were reported in this results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02990858 · results posted 12 November 2025

  According to the results reported on ClinicalTrials.gov, this trial involved 43 people living with HIV who received a treatment called PRO 140, given as an injection under the skin. The trial was measuring how the treatment affected the amount of HIV in participants' blood (called "viral load"), as well as a type of immune cell called CD4 cells, which are important in HIV. Of the 43 people who started, 23 completed the trial and 20 did not finish. The reported data shows that, on average, participants' HIV viral load changed by 0.13 log10 copies/mL over the course of the treatment period (this is a unit used to measure the amount of virus in the blood on a scientific scale). The average CD4 cell count — a measure of immune system activity — changed by 46 cells per microlitre over the treatment period. About 9.3% of participants (roughly 1 in 10) showed a change in the type of HIV virus detected, shifting from one strain type to a mixed type during the study. Regarding reactions at the injection site, 20 participants had mild (Grade 1) reactions and 19 had moderate (Grade 2) reactions, while no participants had severe (Grade 3) reactions reported in this category. Across the whole trial, 12 participants experienced severe or potentially life-threatening side effects (Grade 3 or 4) as assessed by a standard medical scale, and 1 participant stopped taking the study drug due to a treatment-related side effect. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT06039579 · results posted 30 September 2025

  According to the results reported on ClinicalTrials.gov, this trial tested two experimental treatments — called VH4004280 and VH4011499 — in people living with HIV-1 who were not on other HIV medicines at the time. The trial enrolled 44 participants in total, split across several small groups that received one of two dose levels of either treatment, a pre-specified dose of either treatment, or a dummy treatment (placebo). The main thing the trial set out to measure was how much the level of HIV in participants' blood (measured as "HIV-1 RNA," the genetic material of the virus) changed after up to 11 days of receiving the study treatment. All participants who started the treatment phase completed it. The reported data shows that HIV RNA levels in the blood are measured on a logarithmic scale (log10), where a drop of 1.0 on this scale means the virus level fell to one-tenth of what it was at the start. For VH4004280, the maximum reduction from starting levels was reported as −1.056 (Dose Level 1), −1.391 (Dose Level 2), and −1.983 (Pre-specified Dose), compared with −0.070 in the placebo group. For VH4011499, the maximum reductions reported were −1.834 (Dose Level 1), −1.797 (Dose Level 2), and −2.165 (Pre-specified Dose), compared with −0.176 in the placebo group. For the secondary outcomes, the reported data shows the number of participants who experienced any unwanted medical events (called adverse events) during the treatment and follow-up periods. During treatment, these ranged from 2 to 4 participants per active-treatment group and 1 to 2 in placebo groups; during the follow-up period, they ranged from 1 to 5 per active-treatment group. Where severity was recorded, most events were graded as mild or moderate, though some moderate events were also noted; no Grade 4 or Grade 5 (life-threatening or fatal) events were reported in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05938621 · results posted 22 September 2025

  According to the results reported on ClinicalTrials.gov, this trial involved four groups of healthcare providers, with 25 participants assigned to each group (100 in total). The four groups were: a "standard of care" group (no special programme), a "resilience intervention" group, a "resilience and stigma" group, and an "anti-stigma" group. The trial was measuring whether these different programmes were associated with changes in burnout levels among healthcare workers over a six-month period. Each group's participants were also responsible for caring for varying numbers of patients during the study period. The reported data shows that burnout was measured using a tool called the Copenhagen Burnout Inventory, which gives a score between 0 and 100, where higher numbers mean greater burnout. The results show the *change* in those scores from the start of the study to six months later — a negative number means burnout scores went down over that time. According to the results reported on ClinicalTrials.gov, the standard of care group's score changed by −2.0 points, the resilience intervention group changed by −5.9 points, the resilience and stigma group changed by −5.3 points, and the anti-stigma group changed by −3.9 points. No secondary outcome data was reported in the submitted results. Between 20 and 24 participants in each group completed the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT06229132 · results posted 16 September 2025

  According to the results reported on ClinicalTrials.gov, this trial enrolled 25 transgender and gender-diverse individuals, with 22 completing the study and 3 not finishing. The trial was measuring changes in several areas of mental wellbeing, including depression, anxiety, psychological distress, thoughts of suicide, alcohol use, and fear of future rejection based on gender identity. Each of these areas was tracked using a questionnaire with a numbered scale, with participants completing the measures at two points — the results data shows two scores for each measure, which appear to represent a before and after comparison. The reported data shows that, for depression (scored 0–20, where higher means more symptoms), participants' scores went from 9.68 to 4.82. For anxiety (also 0–20), scores went from 10.1 to 5.05. Psychological distress (scored 0–4) went from 1.46 to 1.11. Suicidal thoughts (scored 0–50) went from 8.00 to 4.50. For alcohol use (scored 0–12), scores went from 2.92 to 2.18. Fear of future rejection based on gender identity (scored 0–36) went from 25.7 to 19.9. In every case, the second score was lower than the first, meaning it was in the direction the scales define as a better result — however, how meaningful these changes are clinically was not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05627258 · results posted 22 August 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT05627258) enrolled 23 participants in total, spread across six groups of between 3 and 5 people each. The trial was measuring how participants responded in the short term after receiving a study product — specifically, it tracked any physical reactions near the site where the product was given (called "local" reactions), any whole-body reactions (called "systemic" reactions), and a range of other health and safety markers, including blood test results, new ongoing medical conditions, and serious medical events. These measurements were collected over varying follow-up periods depending on the group (up to 24 or 48 weeks). The reported data shows that, within 7 days of receiving the study product, most groups had between 2 and 4 participants who reported at least one local reaction (such as something at the administration site), and between 2 and 3 participants per group who reported at least one whole-body reaction. Across all six groups, the reported number of serious adverse events (unexpected medical events significant enough to require attention) was zero. For less serious, unplanned health events reported in the 4 weeks after receiving the product, small numbers were recorded — between 0 and 3 participants per group depending on the group. No participants in any group were reported to have developed a new ongoing medical condition following the study product. One participant in Group 4 was reported to have an abnormal laboratory result recorded as an adverse event, and one participant in Group 3 also had an abnormal laboratory result noted. It is worth noting that this was a very small trial with only a handful of participants in each group, so the numbers above reflect very few individuals. The reported data shows counts of participants, not rates or conclusions about the broader population. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01234116 · results posted 15 August 2025

  According to the results reported on ClinicalTrials.gov, this trial enrolled 16 people in total — 8 in a group receiving a medication called Kaletra, and 8 in a group receiving a medication called Raltegravir. Both medications were being used as post-exposure prophylaxis (PEP) — that is, treatment given after a potential exposure to HIV to try to prevent infection. The trial was measuring two main things: signs of unwanted side effects (such as nausea, vomiting, diarrhoea, and changes in liver test results), and whether any participants went on to acquire HIV during the study. Not everyone finished the trial — 4 of the 8 people in the Kaletra group did not complete it, compared with 1 of the 8 in the Raltegravir group. The reasons for not completing were not detailed in the reported data. The reported data shows that when it came to the primary outcome — recorded adverse events (unwanted physical reactions) — 4 adverse events were counted in the Kaletra group and 4 adverse events were counted in the Raltegravir group. It is worth noting that the data as reported gives only these total counts and does not break down which specific reactions occurred or how severe they were. For the secondary outcome, the reported data shows that zero participants in the Kaletra group and zero participants in the Raltegravir group were recorded as having acquired HIV during the study period. It is important to keep in mind that this was a small descriptive study — meaning it was designed to describe and compare what happened in each group rather than to draw firm conclusions — and the numbers involved were very small. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05630885 · results posted 16 July 2025

  According to the results reported on ClinicalTrials.gov, this trial enrolled 110 people in total — 74 in the group receiving a medicine called CVC (Cenicriviroc) and 36 in the placebo group (a dummy treatment with no active ingredient). The trial was measuring changes in arterial wall inflammation — specifically, how much a specialised type of scan called an 18-FDG-PET scan picked up signs of inflammation in the walls of major blood vessels (the aorta and carotid arteries) after 24 weeks. The scan produces a score called a Target-to-Background Ratio (TBR), which compares the activity in the vessel wall to the activity in the surrounding blood — a lower score suggests less detected inflammation. The reported data shows that for the main (primary) outcome — the change in the TBR score of the most inflamed section of the most inflamed vessel — the CVC group had a ratio of 0.95 compared to their starting point, while the placebo group had a ratio of 0.93. A ratio below 1.0 means the score was slightly lower than at the start for both groups. For the secondary outcomes looking at TBR scores across the aorta and carotid arteries individually, the reported figures were very close to 1.0 in both groups, meaning little overall change from baseline was recorded in either group. Blood sugar (fasting glucose) showed a small rise of 1.0 mg/dL in the CVC group and a small fall of 0.5 mg/dL in the placebo group. Measures of insulin resistance showed modest reductions in both groups. Among the inflammation markers in the blood, one chemical called MCP-1 — which was expected to increase with CVC — was reported at 5.0 times its starting level in the CVC group, compared to staying roughly the same (0.99) in the placebo group; the other two inflammation markers (IL-6 and hsCRP) showed similar small changes in both groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03587857 · results posted 1 July 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT03587857) involved a single group of participants who used a mobile app called WYZ. The trial was a feasibility study — meaning it was designed to test whether running a full-scale study would be practical — rather than to prove whether the app does or does not work. The main things being measured were how many people signed up, how often they used the app, and how they engaged with its features, including medication tracking and a peer chat function. A total of 79 people started the study, and 69 completed it over the six-month period. The reported data shows that 79 participants were recruited, which exceeded the pre-set target of at least 55. On average, participants logged into the app approximately 5.3 times per week and spent around 8.7 minutes per week using it. The reported data also shows that, on average, participants tracked their medication (called ART — antiretroviral therapy, a type of HIV treatment) about 58% of the possible times per week. For the peer chat feature, participants posted an average of 4.8 messages per person per week over the six months. For the secondary outcome, the reported data shows that 69 out of the 79 participants who enrolled completed the study at the six-month mark, which represents the participant retention figure. No other secondary outcome numbers were included in the data submitted to ClinicalTrials.gov, so further details are not available here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01351389 · results posted 19 June 2025

  According to the results reported on ClinicalTrials.gov, this trial enrolled 372 people across two groups — 184 received a "Brief Motivational Intervention" (BMI), which is a structured conversation designed to encourage reflection on behaviour, and 188 received "Brief Advice," a shorter, more straightforward form of guidance. The trial was measuring two main things: how much alcohol participants drank, and how many days they engaged in condomless sex (sex without a condom) in the past month. By the end of the study, 154 people in the BMI group and 173 in the Brief Advice group had completed the trial. The reported data shows the following numbers at the end of the study. For alcohol use, the BMI group reported drinking around 9.1 standard drinks per week, compared to 16.5 in the Brief Advice group. For drinks per month, the reported figures across two separate measurement points were approximately 9.2 versus 12.6, and then 8.4 versus 12.1, for the BMI and Brief Advice groups respectively. For condomless sex, the BMI group reported approximately 0.8 and 0.7 days per month (across two measurement points), compared to 1.3 and 1.7 days in the Brief Advice group. At a further measurement point, the reported figures were 0.7 versus 0.9 days. No additional context about when these measurements were taken was provided in the data as submitted. It is worth noting that the reported data does not include information about whether the differences between the two groups were considered statistically meaningful (that is, whether they were likely due to the interventions rather than chance), so those figures should be read simply as the numbers recorded for each group. The data also does not report separate results for participants who did not complete the trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02732730 · results posted 12 June 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT02732730) involved 427 participants in total — 212 in a "Standard Adherence Support" group and 215 in an "Enhanced Adherence Support" group. The trial was measuring how consistently participants took their medication, specifically by testing a biological marker in blood (called TFV-DP) that can indicate whether someone has been taking their tablets regularly. A level of TFV-DP at or above a certain threshold was used as the study's definition of "high adherence" (meaning taking medication consistently as directed). The reported data shows that at six months — the trial's main measurement point — 40 out of 212 participants in the Standard Adherence Support group and 36 out of 215 participants in the Enhanced Adherence Support group met the definition of high adherence. At twelve months, a secondary measurement point, the reported data shows 18 out of the Standard Adherence Support group and 12 out of the Enhanced Adherence Support group met that same definition. The data does not include a full breakdown of why participants who started the trial did not complete it, beyond the numbers who left each group. It is worth noting that the numbers reported here reflect only those participants who reached the high-adherence threshold — the data as submitted does not report on what happened with the remaining participants in detail. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00622843 · results posted 8 June 2025

  According to the results reported on ClinicalTrials.gov, this trial enrolled 229 people across three groups: 131 HIV-positive participants who received a pneumococcal conjugate vaccine (PCV), 73 HIV-positive participants who received a pneumococcal polysaccharide vaccine (PPV), and 25 HIV-negative participants included for comparison. All participants who started the trial completed it. The trial was measuring how the immune systems of HIV-positive people responded to two different types of pneumococcal (pneumonia-related) vaccines, and also tracking any side effects or changes in key health markers over time. The reported data shows that, for the main immune response measure — which looked at whether participants showed a meaningful rise in a specific type of antibody (a protein the body makes to fight infection) for at least two out of four targeted strains — the numbers varied across groups and strains. For example, across the four strains measured, the number of PCV participants meeting this response ranged from 37 to 68 out of 131, while in the PPV group it ranged from 11 to 23 out of 73, and in the HIV-negative group it ranged from 16 to 22 out of 25. Regarding side effects recorded within 7 days of vaccination, 80 PCV participants, 50 PPV participants, and 1 HIV-negative participant reported at least one such event. For secondary measures, the reported data shows small average changes in CD4+ cell counts (immune cells that HIV affects) and viral load (the amount of virus in the blood) after vaccination across the groups, though not all participants attended every follow-up visit. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT05030766 · results posted 4 June 2025

  According to the results reported on ClinicalTrials.gov, this trial looked at two different approaches to help people quit smoking — Mindfulness Training (MT) and Contingency Management (CM) — both combined with Nicotine Replacement Therapy (NRT). The trial ran in two phases. In Phase 1, 49 people were assigned to MT plus NRT and 46 to CM plus NRT. Those who did not quit in Phase 1 could move into Phase 2, where they received the other approach added on top — 12 people continued in an MT plus NRT group with CM added, and 10 in a CM plus NRT group with MT added. The primary outcome the trial measured was the number of participants who reported not smoking at all in the previous 7 days (not even a puff), confirmed by breath or saliva tests. The reported data shows that in Phase 1, at one measurement point 8 people in the MT group and 12 in the CM group met this measure, and at another point 12 people in the MT group and 9 in the CM group met it. In Phase 2, the reported numbers were smaller — between 1 and 3 participants per group at each measurement point. On the secondary outcomes, the reported data shows that the percentage of participants who stayed in the trial through to their final 3-month check-in ranged from about 33% (CM, Phase 1) to 80% (CM with MT added, Phase 2). Attendance at scheduled phone check-in calls — used to measure how closely participants followed their assigned programme — varied across all groups and phases, with full details not clearly separated in the reported data for all sub-measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT04801758 · results posted 20 April 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT04801758) enrolled 18 adults living with HIV who were already on antiretroviral therapy (ART). Participants were divided into three groups: 7 received a lower dose of an experimental antibody called VRC01 (10 mg/kg), 5 received a higher dose of VRC01 (30 mg/kg), and 6 received a placebo (an inactive substance). All 18 participants completed the study. The trial was measuring what happened when people temporarily paused their HIV treatment — a period called an "analytical treatment interruption" or ATI — including how long it took before their HIV levels rose to a point where restarting treatment was needed, and whether anyone was able to stay off treatment for 24 weeks or more without needing to restart. The reported data shows that the median time (the middle value across the group) before participants needed to restart ART was approximately 7.9 weeks in the lower-dose VRC01 group, 8.9 weeks in the higher-dose VRC01 group, and 7.6 weeks in the placebo group. Notably, zero participants in any of the three groups were able to stay off ART for 24 weeks or more without meeting the criteria for restarting treatment. Regarding adverse events (unexpected health changes tracked during the trial), all participants across all groups experienced at least one adverse event of some kind. One participant in the placebo group experienced a serious adverse event; no serious adverse events were reported in either VRC01 group. Some laboratory test results also showed elevated readings meeting a certain grading threshold in participants across the groups, with the reported data showing this occurred in 2 participants in the lower-dose VRC01 group and none in the higher-dose or placebo groups for one measure, and in 4, 2, and 3 participants respectively across the groups for another measure. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT04994444 · results posted 6 April 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT04994444) involved 49 people in total — 23 in a "preloading" group (where nicotine replacement therapy, or NRT, was started before a quit attempt) and 26 in a "standard treatment" group. The trial was measuring how well people stuck to using nicotine patches over an 8-week period, and also looked at how many people reported not smoking at all in the 7 days before a follow-up check. Not everyone finished the trial — 4 people in the preloading group and 6 in the standard treatment group did not complete it. The reported data shows that, on average, people in the preloading group used their nicotine patches for about 47.4 days out of the 8 weeks (roughly 56 days) of patch supply, while people in the standard treatment group used them for about 32.7 days on average. For the secondary measure — the number of people who reported no smoking in the past 7 days — the reported data shows 4 participants in the preloading group and 4 participants in the standard treatment group met this measure. No further breakdown of those quit figures was reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT03157167 · results posted 5 March 2025

  According to the results reported on ClinicalTrials.gov, this trial enrolled 15 people in total across three groups, each receiving a different dose of a radioactive imaging agent called Tc99m-Tilmanocept. The participants all had HIV and had been diagnosed with Kaposi's sarcoma (KS), a type of cancer affecting the skin and other tissues. The trial was testing whether the imaging agent could be given safely at increasing doses, and whether it could show up on scans in KS-affected areas of the body. The three groups received either 100 micrograms with 5 millicuries of radioactivity, 100 micrograms with 10 millicuries, or 200 micrograms with 5 millicuries. One participant in the first group did not complete the study; all others finished. The reported data shows that the primary outcome — tracking what were called "safety signals" (recorded concerns picked up during health checks including blood tests, heart tracings, and physical examinations) — recorded zero safety signals across all three dose groups. For the secondary outcomes, the trial looked at how many participants had the imaging agent show up in at least one KS lesion on their scans. When the agent was given by intravenous (IV) drip, all 4 participants in the first group and 1 out of 4 in the second group had at least one lesion show up on imaging; in the third group, none of the 6 participants showed lesion detection via IV. However, when the third group also received the agent by injection under the skin (subcutaneous), 4 out of 6 participants had at least one lesion detected. The reported data shows that a virus marker linked to KS (called HHV8, measured to confirm KS cells were present in biopsied tissue) was detected in samples from both the second and third groups, with the third group showing higher average levels. The trial also looked at the intensity of the imaging signal and how well the two injection methods matched up in detecting the same lesions, though the reported data shows these results were limited — for example, the signal intensity analysis was not completed for the first group, as this measurement was introduced after that group had already finished. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT05482360 · results posted 26 February 2025

  According to the results reported on ClinicalTrials.gov, this trial looked at three different support packages designed to help healthcare workers offer HIV prevention medication (known as PrEP) to pregnant and postnatal women at clinics in Kenya. Each package was compared against a control group receiving usual care. Across the baseline and intervention periods, roughly 400 or more women participated in each of the six groups, with all participants completing both phases of the study. The trial measured several things: how many women were screened for PrEP, how completely healthcare workers carried out the required PrEP-related steps during visits, how long women waited and how long their consultations took, and how acceptable and appropriate healthcare workers found each package. The reported data shows that the number of women screened for PrEP (out of those attending antenatal or postnatal services) varied across groups and time points. For example, Package 3 had 49 women screened at one time point compared to 23 in its comparator group, and Package 2 had 93 women screened versus 22 in its comparator. For PrEP fidelity — meaning whether all the required steps were completed during a visit — Package 2 reported 55 women receiving complete care versus 8 in its comparator, and Package 3 reported 61 versus 8. Waiting times ranged roughly from about 31 to 47 minutes across groups and time points, while time spent with a healthcare worker was generally around 12 to 15 minutes across all groups. The reported data shows no single waiting-time figure that was consistently shorter across all packages and periods. When healthcare workers were asked how acceptable and appropriate they found each package — rated on a scale of 4 to 20, where 20 is the highest possible score — the reported scores were generally high. Acceptability scores were reported as 18.5 for Package 1, 18 for Package 2, and 20 for Package 3. Appropriateness scores were reported as 18 for Package 1, 19 for Package 2, and 20 for Package 3. These scores reflect only what healthcare workers reported on the survey scale, and comparator groups were not assessed on these measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT03386578 · results posted 19 February 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT03386578) involved pregnant women living with HIV and their infants, and was studying a medication called tenofovir (part of HIV treatment) taken during pregnancy and after birth. The trial had two main parts. The first part — the pharmacokinetics (PK) component, which looks at how a drug moves through the body — enrolled 20 mothers in each of two groups (40 mothers total), along with their infants. The second, larger part compared women who took pre-exposure prophylaxis (PrEP, a medicine to help prevent HIV) with those who did not, enrolling 229 mothers in one group and 121 in another, plus their infants. A small follow-on step enrolled 13 mothers and 13 infants. The reported data shows that the PK component established a concentration threshold — essentially a target level of the drug measured in a dried blood spot (a small sample of blood on a card) — that the researchers used to define "optimal adherence," meaning taking the full prescribed number of doses each week. That threshold was reported as 965 fmol/punch for one group of mothers and 1,050 fmol/punch for the other. Using that threshold, the trial then measured what proportion of mothers in the PrEP comparison group met that target at different points in time. The reported data shows that 15% of PrEP-exposed mothers met the optimal adherence threshold at study week 4 of pregnancy, rising to 23% at week 8, 27% at week 12, and 31% at the time of delivery, before dropping back to 20% at six weeks after birth. The reported results did not include a corresponding figure for the PrEP-unexposed comparison group for these measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT05549726 · results posted 24 January 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT05549726) enrolled 984 participants in total — 487 in the "Dynamic Choice Prevention" group (which included access to a long-acting injectable option called cabotegravir, or CAB-LA) and 497 in the "Standard of Care" group. The trial was measuring how much of the time participants were covered by biomedical HIV prevention — meaning they were actively using a prescribed prevention method, such as daily prevention pills (PrEP) or post-exposure pills (PEP) — and whether new HIV infections occurred during the study period. The reported data shows that, for the main outcome, participants in the Dynamic Choice Prevention group were covered by a biomedical prevention method for about 69.7% of the days measured, compared to 13.3% of days for those in the Standard of Care group. For the secondary outcome looking at new HIV infections, the Dynamic Choice Prevention group recorded 0 infections per 100 person-years (a way of counting new cases that accounts for how long people were followed), while the Standard of Care group recorded 1.8 infections per 100 person-years. Two other secondary outcomes — one also measuring new HIV infections using a slightly different calculation method, and one measuring prevention use during periods when participants felt they were personally at risk — had no data reported for them on ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT03367754 · results posted 17 January 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT03367754) enrolled a total of 7 participants — 6 in the pembrolizumab (drug) group and 1 in the placebo group. All 7 participants completed the study with none dropping out. The trial was measuring how often participants experienced certain unwanted health events: specifically, moderate immune-related reactions (known as "grade 2 or higher autoimmune events") that needed steroid treatment, or more serious side effects (grade 3 or higher) that may have been linked to the treatment. Grades refer to a standard scale used to describe how severe a health event is, ranging from mild (grade 1) through to life-threatening (grade 4) or fatal (grade 5). The reported data shows that across both groups — the pembrolizumab group and the placebo group — zero participants experienced any of these measured health events at any severity level. In other words, none of the 7 people in the trial recorded a moderate immune reaction requiring steroids, and none recorded a serious or severe side effect considered possibly related to the intervention, according to the reported figures. It is worth noting that this was a very small trial with only 7 participants in total, and the data as submitted does not include any secondary outcome measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT04212091 · results posted 13 December 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT04212091) enrolled a total of 33 participants, split across six groups all receiving a vaccine. The groups ranged in size from 3 to 10 people. The trial was measuring short-term reactions at the injection site (such as pain, tenderness, redness, and swelling), whole-body reactions after vaccination (such as fatigue, headache, nausea, muscle aches, chills, and joint pain), and routine blood test results (including liver-related markers, kidney function, and haemoglobin levels). Most participants completed the study — 30 out of 33 finished, with 3 people not completing (2 from Group 5 and 1 from Group 6). The reported data shows that injection-site pain or tenderness was recorded in all participants in Groups 1 through 4 (3 people in each group), in 8 out of 10 in Group 5, and in 10 out of 10 in Group 6. For redness or swelling at the injection site, all participants in Groups 1 through 4 reported this, as did all 10 in Group 5, and 8 out of 10 in Group 6. For whole-body symptoms, the numbers varied by group: all 3 in Group 1 reported some, compared to 3 out of 4 in Group 2, 3 out of 3 in Group 3, 3 out of 3 in Group 4, 8 out of 10 in Group 5, and 9 out of 10 in Group 6. The reported data shows that blood test results — including liver enzyme levels, kidney function (creatinine), and haemoglobin — were recorded at multiple time points, with median values across groups appearing broadly similar before and after vaccination; however, the full range of individual results was not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT03803683 · results posted 26 November 2024

  According to the results reported on ClinicalTrials.gov, this trial enrolled 523 young people across three groups: 211 received access to an app called mLab, 208 received standard HIV information (the control group), and 104 were given HIV home testing kits. The trial was measuring how many young people in each group got tested for HIV, whether those tests came back negative or positive, and whether participants connected with HIV care services — all tracked at 6 months and again at 12 months. The reported data shows that when it came to HIV testing at 6 months, 154 participants in the mLab app group, 123 in the standard information group, and 68 in the home testing group had been tested. At 12 months, those numbers were 145, 109, and 64 respectively. For the secondary outcome of HIV test results, the reported data shows that across all three groups and at both time points, zero positive results were recorded — meaning all tests that were conducted returned a negative result. For the outcome measuring how many participants linked to HIV care services, the reported data shows zero participants across all three groups at both 6 and 12 months, though it is worth noting this figure would be expected to be zero given no positive results were recorded. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT05789875 · results posted 26 August 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT05789875) enrolled 28 participants in a single group who used a smartphone app called AiCure to record themselves taking their medication. The trial was not testing whether a treatment worked medically — instead, it was a feasibility study, meaning it was designed to find out whether running a larger trial using this app would be practical, and whether participants found the app acceptable to use. The reported data shows that 22 out of 28 participants completed the study. Of those who finished, all 22 reported satisfaction scores on the Client Satisfaction Questionnaire at or above the threshold the researchers set for acceptable satisfaction, and 18 out of 22 scored above the threshold on a separate usability scale (called the System Usability Scale, which measures how easy something is to use). The reported data also shows that participants spent an average of 28 seconds per day in the app. Regarding medication recording, the app's artificial intelligence flagged what it identified as unusual dosing patterns — described in the study as possible "falsified" medication-taking — in approximately 2% of recorded doses on average. The number of logins per week was listed as a primary outcome measure, but no figures for that measure were reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT02709759 · results posted 22 August 2024

  According to the results reported on ClinicalTrials.gov, this trial enrolled 188 people across eight groups, each receiving a different combination of alcohol-reduction approaches. The interventions included two types of counselling sessions — Motivational Interviewing (MI) and Brief Advice (BA) — along with two add-on components referred to as ITM and EI. Participants were spread roughly evenly across the eight groups (around 23–24 people each), and between 14 and 18 people in each group completed the study. The trial's main goal was to track how much alcohol participants were drinking — specifically, the average number of drinks per week and the number of "heavy drinking days" (defined as five or more drinks in a single day) — at both six and twelve months. The reported data shows the following average drinks per week at six months: MI Only – 13.3, BA Only – 14.9, MI + ITM – 7.5, BA + ITM – 5.0, MI + ITM + EI – 9.6, BA + ITM + EI – 7.6, BA + EI – 7.7, and MI + EI – 17.8. At twelve months, the reported figures were: MI Only – 8.3, BA Only – 16.5, MI + ITM – 4.6, BA + ITM – 3.7, MI + ITM + EI – 5.4, BA + ITM + EI – 8.1, BA + EI – 7.0, and MI + EI – 11.6. For heavy drinking days at six months, the reported averages ranged from 1.4 days (BA + ITM) to 6.1 days (MI + EI), and at twelve months from 1.2 days (BA + ITM) to 5.6 days (BA Only). No additional detail about why these differences occurred between groups was reported in the structured data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT03555396 · results posted 3 July 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT03555396) enrolled 132 people in total — 64 in the intervention group and 68 in the standard of care group. Each group was made up of two types of participants: people living with HIV (called "index cases") and a "treatment support partner" — someone close to them who helped support their care. The trial was measuring how well people stuck to their HIV medication (called antiretroviral therapy) over a 180-day period, using an electronic pill bottle that recorded each time it was opened. It also looked at HIV virus levels in the blood, how participants rated their own medication-taking, and whether they were receiving treatment for substance use. The reported data shows that, for the main measure — the number of days the electronic pill bottle was opened out of 180 — the intervention group recorded an average of 10.49 days, while the standard of care group recorded an average of 14.02 days. For the secondary measures, the self-reported medication adherence score (on a scale of 0 to 100, where 100 means perfect adherence) started at similar levels for both groups (69.29 for the intervention group and 68.33 for standard of care), and at the 6-month follow-up the intervention group scored 86.73 compared to 76.23 for standard of care. Regarding HIV virus levels in the blood being low enough to be considered "suppressed," the reported data shows 14 intervention participants and 11 standard of care participants were suppressed at the start, and 14 intervention versus 18 standard of care participants were suppressed at the 6-month follow-up. For substance use treatment access, 1 participant in the intervention group and 3 in the standard of care group reported currently receiving methadone or opioid substitution therapy — noting that this measure appears to reflect a single point in time rather than a before-and-after comparison. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT04893018 · results posted 27 June 2024

  According to the results reported on ClinicalTrials.gov, this trial looked at a drug called efineptakin alfa (also called NT-I7) and tested it at two different dose levels. A total of 8 people took part — 6 received the lower dose and 2 received the higher dose. The main thing the trial was measuring was how many participants experienced adverse events (that is, any unwanted or unexpected medical occurrences during the study). Secondary measures included whether the disease responded to treatment, how long any response lasted, how long participants lived without the disease getting worse, overall survival, and changes in the levels of certain immune cells (called lymphocytes) in the blood. The reported data shows that 100% of participants in both dose groups experienced adverse events. For the secondary measure looking at disease response, the reported data shows that no participants in either group achieved a complete response (where the disease disappears entirely). However, 1 participant in the lower dose group and 2 participants in the higher dose group were reported to have achieved a partial response (where the disease reduced but did not disappear fully). The reported data shows that figures for how long responses lasted, how long participants went without the disease worsening, and overall survival were not reported in the submitted results. Regarding immune cell levels in the blood, the reported data shows that lymphocyte counts appeared to rise over time in both groups, with the median fold-change (a way of describing how many times higher the count became compared to the starting level) reaching around 3.0 times the starting level in the lower dose group and around 3.9 times in the higher dose group at one measured point. It is worth noting that this was a very small trial with only 8 participants across both groups, and only 2 of the 6 participants in the lower dose group and none in the higher dose group were recorded as having completed the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT03898557 · results posted 26 June 2024

  According to the results reported on ClinicalTrials.gov, this trial involved 1,478 people split into two groups: 747 in a "Usual Care" group (the standard approach) and 731 in a "Plan and Pledge" group (an approach that encouraged people to make a plan and commitment around HIV self-testing). The trial was measuring whether people who received an HIV self-test would report their result back through a dedicated WhatsApp number, and how many of those results were positive. The reported data shows that, for the primary outcome — people who reported their self-test result via WhatsApp — 59 people in the Usual Care group reported a result, compared with 63 people in the Plan and Pledge group. The remaining participants in each group (688 in Usual Care and 668 in Plan and Pledge) did not report a result through this channel. For the secondary outcome, which looked specifically at positive HIV test results reported, the data shows 59 reported results in the Usual Care group and 63 in the Plan and Pledge group, with zero recorded in a separate category — though the way the numbers are broken down in the submitted data makes the full picture difficult to interpret clearly. Several other planned measures — including follow-up consent, successful follow-up contact, on-site testing rates, and confirmatory testing rates — had no data reported on ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT02199184 · results posted 11 June 2024

  According to the results reported on ClinicalTrials.gov, this trial enrolled 14 participants, all of whom completed the study. All participants received a combination chemotherapy regimen (DA-EPOCH) together with one of two antibody medicines — ofatumumab or rituximab. The trial was measuring how many people achieved a complete remission (meaning their blood counts returned to normal levels, bone marrow showed very low levels of disease cells, and any disease outside the bone marrow fully cleared), as well as how long participants survived and how long any remission lasted. The reported data shows that out of the 14 participants, 9 were recorded as achieving a complete remission as defined by the trial. For the time-based measures, the reported data shows an overall survival time — meaning the average time from the start of treatment until death or last check-in — of 15.1 months. The event-free survival figure, which tracks the time from starting treatment until the first sign that the disease had returned, was reported as 3.3 months. For those who did reach complete remission, the duration of that remission — from when remission was recorded until it was lost or the last follow-up — was reported as 10.0 months. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03497676 · results posted 14 May 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT03497676) involved two separate groups of participants. The first group (Cohort 1) included 30 people who received a study drug called cabotegravir (CAB) and 25 who received a study drug called rilpivirine (RPV). The second group (Cohort 2) started with 144 participants who received a combination of both drugs, first taken by mouth and then as long-acting injections. The trial was measuring things like how often participants experienced serious or severe unwanted health events (called adverse events) while taking the study drugs. The reported data shows that for Cohort 1, across several measures tracked in the first four weeks — including severe adverse events (grade 3 or higher), severe adverse events judged to be related to the study drugs, serious adverse events related to the study drugs, stopping the study drug due to related adverse events, and deaths related to the study drugs — the reported proportion of participants experiencing these events was 0 (meaning none were recorded in that early period for the CAB group, which was the only group reported for those specific measures). When looking at the full 16-week period for Cohort 1, the reported data shows that 0.24 (about 24 in every 100 participants) in the CAB group and 0.22 (about 22 in every 100 participants) in the RPV group had at least one severe or higher-grade adverse event. Outcome data for Cohort 2 was not reported in the results provided. It is worth noting that the data submitted covers only some of the outcome measures, and figures for a number of other planned measures were not included in what was reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT03902418 · results posted 19 March 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT03902418) enrolled 1,195 pregnant women in a single study group focused on PrEP use — PrEP (pre-exposure prophylaxis) being a daily tablet taken to reduce the chance of getting HIV. Of those who started, 1,092 completed the study and 103 did not. The trial was measuring how many women started taking PrEP during pregnancy and after giving birth, and how consistently they were taking it at certain points in time. The reported data shows that 1,089 participants began taking PrEP during their pregnancy, and 1,009 went on to initiate PrEP after giving birth. To get a sense of how consistently participants were taking the medication, the trial tested blood samples for drug levels. At the 3-month mark while on PrEP, 256 participants had drug levels in their red blood cells above the threshold used in the study (above 40 nanograms per millilitre, which was the level researchers were looking at). For the 6-month check after giving birth, the reported data shows that 86 participants had any detectable drug levels among those who said they had taken PrEP in the previous 30 days, and of those, 51 had levels above that same threshold. For the secondary outcome, looking at whether the type of sexually transmitted infection (STI) testing offered made a difference to PrEP uptake, 89 participants in the point-of-care STI testing group started PrEP compared with 84 in the group receiving standard symptom-based STI assessment — however, the data does not report the total group sizes, so these raw numbers cannot be put into fuller context. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT04558554 · results posted 15 March 2024

  According to the results reported on ClinicalTrials.gov, this trial looked at whether pharmacies could be used as a place for people to start and continue taking PrEP — a medication taken to reduce the chance of getting HIV. The trial had three parts: Study 1a followed 287 people over 13 months at pilot pharmacies; Study 1b followed 106 people over 12 months who had started PrEP at a clinic and could choose to refill at a pharmacy; and Study 2 followed 823 people over 6 months as an extension of the pharmacy pilot. All participants who started each part of the trial completed it, with no dropouts recorded. The reported data shows that 287 people began PrEP at pilot pharmacies during Study 1a, and 661 people did so during Study 2. When it came to continuing (refilling) their PrEP, the data reports that in Study 1a, 153 people were counted as eligible to refill and 134 of them did so at a pilot pharmacy. In Study 1b, 41 people were eligible to refill and 65 refills were recorded across pharmacies or clinics. In Study 2, 476 people were eligible to refill and 185 did so at a pilot pharmacy. For PrEP adherence — measured by checking drug levels in a small number of randomly selected blood spot samples — 16 samples were tested in both Study 1a and Study 2, though the actual drug-level results were not reported in the data submitted. The reported data also shows that during Study 2, 162 people started PEP (a short-term medication taken after a possible HIV exposure), 53 people chose to have an STI (sexually transmissible infection) test at a pilot pharmacy, and only 3 people in Study 1b chose to switch their PrEP refills from a clinic to a pharmacy. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04846569 · results posted 28 February 2024

  According to the results reported on ClinicalTrials.gov, this trial enrolled 43 women living with HIV who were navigating the period after giving birth — a time when staying connected to HIV care can be challenging. Twenty-three were placed in a group that received a counselling-based support programme (called a "Transition Theory-based Intervention"), and 20 were in a comparison group that received an enhanced version of standard care. The trial was exploring whether the programme was practical to deliver and gathering early numbers on things like medication-taking, keeping clinic appointments, and virus levels in the blood at six months after birth. The reported data shows that participants in the intervention group completed an average of about 2.92 counselling sessions, while those in the comparison group completed an average of 1 session. When it came to self-reported HIV medication adherence (measured on a scale where 100 means perfect adherence over the past month), the intervention group scored 82.65 and the comparison group scored 82.73 — very similar numbers. For staying connected to HIV clinic appointments, 17 out of 20 participants in the intervention group and 15 out of 19 in the comparison group had attended a clinic in the three months before the six-month check-in. Regarding virus levels in the blood being kept very low (below 200 copies per millilitre, described as "viral suppression"), 11 participants in the intervention group and 7 in the comparison group met that measure. On a secondary measure of confidence in taking medications (scored from 15 to 75, with higher meaning more confident), the intervention group averaged 63.93 and the comparison group averaged 69.55. The reported data also shows that 11 participants from the intervention group took part in in-depth interviews about how acceptable and useful they found the programme, though detailed findings from those interviews were not reported in the structured data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT03198559 · results posted 9 February 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT03198559) enrolled 2 participants, all in a single treatment group. The study was testing a combination of two drugs — disulfiram (taken continuously for 11 days) and vorinostat (taken on three of those days) — in people living with HIV who were already on antiretroviral therapy that was keeping their virus suppressed. The trial was measuring changes in the amount of HIV detectable in the blood and in immune cells over time. Notably, neither of the 2 participants completed the study. The reported data shows that for the primary outcome — the change in the level of HIV detectable in the blood (plasma HIV RNA) from the start to day 11 — the two participants had fold-change values of 1 and 13.5 respectively (a "fold change" simply means how many times higher or lower a measurement was compared to the starting point; a value of 1 means no change). For a secondary outcome looking at HIV levels in the blood at additional time points across the study, the reported fold-change values for the two participants ranged from 1 (no change) up to 45.9 at various points, then appeared to decrease again. The reported data also shows that both of the 2 participants experienced at least one adverse event (an unexpected medical occurrence during the study period). Additional measurements of HIV activity within immune cells were also reported across multiple time points, with fold-change values varying across those time points for both participants; the data was not reported in a way that allows a straightforward summary of trends for each individual. Because only 2 participants were enrolled and neither completed the trial, the reported data shows results from a very small and incomplete dataset. No conclusions about broader patterns can be drawn from numbers this limited. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT05005130 · results posted 30 January 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT05005130) looked at a program called TASKPEN, which was designed to help people living with both HIV and high blood pressure manage both conditions at the same time through their existing clinic visits. The trial took place across two clinic clusters in Zambia — one called George (Cluster 1) and one called Chilenje (Cluster 2). A total of 448 people were enrolled at the start, with numbers reducing over the course of the study through a midpoint check-in and a final survey. Healthcare providers at the clinics were also included in some measurements. The reported data shows that the main thing being measured was the percentage of participants who had both their HIV and blood pressure under control at the same time. In the standard care group, 52% of participants achieved this combined control, compared with 60% in the TASKPEN group. Looking at HIV control alone, the reported data shows 85% in the standard care group had their HIV virus at a low level, compared with 89% in the TASKPEN group. For how the intervention spread through the clinics, the data shows one clinic in each group adopted the program. The reported data also shows that 29 healthcare providers were trained at the George clinic and 60 at the Chilenje clinic. Healthcare providers were also asked to rate how appropriate and acceptable they found the approach, using a scale of 1 to 5. For appropriateness, providers scored it 4.69 during standard care and 4.18 during TASKPEN. For acceptability, the scores were 4.70 during standard care and 4.34 during TASKPEN. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT04900038 · results posted 14 December 2023

  According to the results reported on ClinicalTrials.gov, this trial enrolled 85 adults who had HIV-1 and had never previously taken antiretroviral (HIV) treatment. Participants were divided into four groups to compare three different doses of an investigational drug called GSK3640254 (100 mg, 150 mg, or 200 mg), each combined with an existing HIV drug called dolutegravir (DTG), against a standard two-drug combination of dolutegravir and lamivudine (3TC). The main thing the trial was measuring was how many participants in each group had their HIV virus levels drop below 50 copies per millilitre of blood at 24 weeks — a standard marker used in HIV research. It is worth noting that the sponsor ended the trial early, and only a small number of participants in each group (2–3 out of 20–22) completed the full study. The reported data shows that at 24 weeks, the percentage of participants with virus levels below 50 copies per millilitre was 95% in the 100 mg GSK3640254 group, 85% in the 150 mg group, 77% in the 200 mg group, and 86% in the standard dolutegravir/lamivudine comparison group. The reported data also shows changes in immune cell counts (CD4+ T-cells, which are tracked in HIV care): average counts appeared to rise across all four groups over the 24 weeks, with increases ranging from approximately 140 to 318 cells per cubic millimetre depending on the group. Regarding serious adverse events (unexpected medical events significant enough to require hospitalisation or other major intervention), 2 were reported in the 100 mg GSK3640254 group and 1 in the comparison group; none were reported in the 150 mg or 200 mg groups. No deaths were reported in any group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT05074251 · results posted 8 December 2023

  According to the results reported on ClinicalTrials.gov, this trial enrolled 180 people across two groups — 86 in the HIV Self Testing group and 94 in the Standard of Care group. The trial was looking at whether providing HIV self-testing kits would lead to more partners of people living with HIV getting tested, compared to the usual testing approach. Most participants completed the study (85 in the self-testing group and 91 in the standard care group). The reported data shows that for the main outcome — how many participants reported that their partner got tested for HIV — 66 people in the HIV Self Testing group reported their partner was tested, compared to 50 in the Standard of Care group. For the secondary outcomes, the number of male partners who tested positive for HIV was 9 in the self-testing group and 6 in the standard care group. The number of those partners who then started antiretroviral therapy (medication used to treat HIV) was 6 in each group. For the final secondary outcome — the proportion of partners who achieved viral suppression (meaning the virus became undetectable in the blood) — no data was reported on ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT04609514 · results posted 19 October 2023

  According to the results reported on ClinicalTrials.gov, this trial (NCT04609514) involved 43 people in total — 22 assigned to an app called "Learn to Quit-HIV" and 21 assigned to a comparison app called "QuitGuide." Both apps were designed for people living with HIV who smoke. The trial was not testing whether the apps helped people quit smoking; instead, it was measuring practical things like how much people used the apps, how many people dropped out over time, and whether the study was able to sign up enough participants. These kinds of measures are typically used in smaller, early-stage studies to see whether a larger trial would be feasible. The reported data shows that, on average over the three-month study period, people in the Learn to Quit-HIV group used their app for about 12 minutes per day, compared with about 1 minute per day in the QuitGuide group. For how often people opened the app each day, the Learn to Quit-HIV group averaged roughly 1.9 interactions per day, while the QuitGuide group averaged about 1.2. The reported data also shows that the number of participants who dropped out grew over time: by the one-month mark, 2 people had left the Learn to Quit-HIV group and 5 had left the QuitGuide group; by two months, those numbers were 4 and 7 respectively; and by three months, it was 7 in each group. Regarding recruitment, the trial aimed to enrol 60 participants but consented 43, which the data records as reaching 85% of the recruitment goal. No data on smoking outcomes was reported in the structured results submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT04542070 · results posted 13 September 2023

  According to the results reported on ClinicalTrials.gov, this trial (NCT04542070) enrolled people living with HIV-1 who were already on treatment, to compare a new every-two-months injectable regimen (referred to as Q2M) against a daily oral tablet called Biktarvy. The injectable group was split into two starting pathways — one group took oral lead-in tablets first (175 people) before moving to injections, and another group went directly to injections (279 people) — while 227 people took Biktarvy daily. The main thing the trial was measuring was how many participants still had detectable levels of HIV in their blood (at or above 50 copies per millilitre) at around the 11–12 month mark. The reported data shows that, at the 11–12 month point, 1.3% of participants in the combined injectable (Q2M) group had detectable HIV levels at or above 50 copies per millilitre, compared with 0.4% in the Biktarvy group. A second, slightly different analysis of the same primary measure reported 1.1% for the injectable group and 0.4% for the Biktarvy group. On the flip side — looking at those with HIV levels *below* 50 copies per millilitre, which is generally what treatment aims for — the reported data shows 89.4% of the injectable group and 93.0% of the Biktarvy group met this threshold at around 11–12 months. At the earlier 5–6 month check, those figures were 92.7% for the injectable group and 97.8% for the Biktarvy group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT04089488 · results posted 22 August 2023

  According to the results reported on ClinicalTrials.gov, this was an observational study — meaning researchers watched and recorded information rather than testing a treatment. A total of 175 people living with HIV who also had a cancer diagnosis took part, and all 175 completed the study. The study was measuring how often people with both HIV and cancer were seen at a small number of clinical sites over a 21-month period, looking at both newly diagnosed cases and existing (ongoing or returning) cases. Participants responded to surveys and had their medical records reviewed. The reported data shows that across the clinical sites, the number of newly diagnosed HIV-and-cancer cases seen at each site over the 21 months ranged from single figures to around 13 people per site. When broken down by cancer type, the reported average rate of new cases per month ranged from 0 (for one cancer category) up to about 1.19 new cases per month for the most common cancer type recorded. For existing cases — people already known to have both conditions — the reported average rate per month at each site ranged from roughly 0.29 to 3.48 cases per month, and by cancer type ranged from 0.14 to 2.14 cases per month. The reported data also shows that for the secondary measure — how diagnostic testing was used — the number of participants who had particular types of testing ranged from 1 to 62 people, though the full labels for each testing category were not included in the data available, so a more detailed breakdown cannot be provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT04143009 · results posted 14 August 2023

  According to the results reported on ClinicalTrials.gov, this was a pilot trial involving women living with HIV who were also experiencing symptoms of depression during or after pregnancy. The trial tested two versions of a counselling programme called the "Friendship Bench" — one adapted version (AFB) and one enhanced version (EFB) — and compared them against enhanced standard care (ESC). A small pre-pilot phase included 12 women (5 in AFB, 3 in EFB, 4 in ESC), while the main pilot enrolled 80 women (40 in EFB and 40 in ESC). The trial was primarily measuring whether the programme was feasible to run and acceptable to participants, rather than testing whether it worked as a treatment. The reported data shows that across both pilot phases, a total of 5 women were enrolled in the AFB group, 43 in the EFB group, and 44 in the ESC group. Nearly all participants stayed in the trial through to six months after giving birth — the reported retention rate was 100% for AFB, and 98% for both EFB and ESC. All of the EFB participants who responded to a follow-up survey reported being "satisfied" or "highly satisfied" with how easy the programme was to participate in (a proportion of 1.0, meaning 100% of respondents). When counselling sessions were observed, 83% of EFB sessions were reported to have covered at least 80% of the required programme checklist items. The reported data also shows results for a combined secondary measure that looked at whether women were both staying engaged in their HIV care and had shown at least a 50% improvement in their depression score (measured using a standard 20-question tool) at six months. In the AFB group, 20% of participants met this combined outcome; in the EFB group, 40% did; and in the ESC group, 14% did. A separate pre-specified measure looked at the proportion of women still scoring at or above the threshold that can indicate a common mental health condition at six months — this was reported as 60% for AFB, 21% for EFB, and 30% for ESC. These numbers describe what was observed and recorded in this small pilot study, and the trial was not designed to draw firm conclusions about whether any approach is better than another. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT03797014 · results posted 18 July 2023

  According to the results reported on ClinicalTrials.gov, this trial enrolled 28 people who were living with both HIV and hepatitis B (HBV) at the same time. All participants received a single combination medicine called B/F/TAF. The trial was measuring two main things at 24 weeks: how many participants had their HIV kept below a very low level in the blood (less than 50 copies per millilitre), and how many had their hepatitis B virus also kept below a very low level (less than 29 IU/mL). Of the 28 people who started, 25 completed the study and 3 did not. The reported data shows that at the 24-week mark, 25 out of 28 participants had HIV levels below the target threshold, and 24 out of 28 had hepatitis B levels below their target threshold. At 48 weeks — a later follow-up point measured as a secondary outcome — the reported data shows that 22 out of 28 participants had HIV below the threshold, and separately, 22 out of 28 had hepatitis B below the threshold. The trial also tracked CD4 cell counts (a type of immune cell used to monitor HIV). The reported data shows that, on average, CD4 counts changed by approximately +32.8 cells per microlitre from the starting point to week 24, and by approximately +76.6 cells per microlitre from the starting point to week 48. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT01935089 · results posted 6 July 2023

  According to the results reported on ClinicalTrials.gov, this trial (NCT01935089) enrolled 20 people, all of whom received Interferon Alpha. Of those 20 participants, 17 completed the study and 3 did not finish. The trial was measuring a specific aspect of HIV — namely, how much HIV genetic material (called HIV DNA) was present inside a type of immune cell known as a CD4+ T cell. This was measured at the start of the study and again at 24 weeks, to see whether that amount changed over time. The reported data shows the primary outcome was the change in HIV DNA copies per CD4+ T cell between the start of the study (baseline) and week 24. The numbers reported appear to show two separate measurements of 113 and 98 HIV DNA copies per CD4+ T cell, however the data as submitted does not clearly distinguish which figure represents the baseline measurement and which represents the week 24 measurement, nor does it provide a clearly labelled "change" figure. As a result, a straightforward before-and-after comparison cannot be fully described from the data available. No secondary outcome measures were included in the submitted results data. It is worth noting that only one group took part in this trial — everyone received the same treatment — so there was no comparison group reported in this dataset. The trial used a laboratory technique called polymerase chain reaction (a highly sensitive method for detecting and measuring genetic material) to count the HIV DNA copies. No other outcome data was reported in the structured results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT03212989 · results posted 12 May 2023

  According to the results reported on ClinicalTrials.gov, this trial (NCT03212989) enrolled 17 participants, all of whom received a combination treatment involving a drug called vorinostat (VOR) and specially prepared HIV-targeting immune cells called HIV-specific T cells (HXTC). The trial had one group only — there was no comparison or placebo group. All 17 participants completed an initial blood collection step, but only 9 went on to receive the full course of treatment and finish the study. The remaining 8 did not complete the trial, though the reasons are not detailed in the reported data. The reported data shows that the main (primary) thing being measured was how many participants experienced a serious unwanted reaction (graded "Grade 3 or above" — meaning significant or severe) that was thought to be possibly or definitely linked to either vorinostat or the T-cell infusions. According to the results reported on ClinicalTrials.gov, the number recorded for this was zero out of the participants treated. The secondary outcome looked at two things together: whether participants showed a measurable HIV-targeted immune response, and whether there was a change in the amount of dormant (latent) HIV still present in their bodies — assessed using laboratory tests. The reported data shows that the number of participants who demonstrated both of these changes at the same time was also recorded as zero. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT02175680 · results posted 14 April 2023

  According to the results reported on ClinicalTrials.gov, this trial enrolled 43 adults, all of whom received a weekly under-the-skin injection of a drug called PRO 140 (at a dose of 350 mg). Forty-one of the 43 participants completed the study; two did not finish. The trial was measuring how long it took for the HIV virus in participants' blood to rebound to a detectable level (called "virologic failure") after they switched to PRO 140 as their only HIV treatment, as well as tracking changes in virus levels and immune cell counts over a 14-week period. The reported data shows that, on average, the time until virologic failure occurred was about 71 days. Virologic failure was defined as two blood tests in a row showing HIV levels of 400 copies per millilitre or higher. Among all participants, approximately 44% (just under half) experienced virologic failure at or before the 14-week mark. For those who did experience virologic failure, the reported data shows their virus level at that point was, on average, about 1.78 units lower (on a logarithmic scale — a mathematical way of expressing large ranges of numbers) than it was at the start of the study. The reported data also shows that virus levels across the group trended downward over most of the 14 weeks, with the largest average reduction recorded at around week 11. Changes in CD4 cells — a type of immune cell often monitored in people with HIV — fluctuated across visits, with an overall average change from the start of the study of approximately +19 cells per cubic millimetre reported at the end of the treatment phase. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT02990325 · results posted 31 March 2023

  According to the results reported on ClinicalTrials.gov, this trial (NCT02990325) enrolled 36 people with HIV who were divided into three groups: 11 people received a 150 mg dose of a study drug called ABX464, 12 people received a 50 mg dose for 28 days, and 13 people received a 50 mg dose for 84 days. All 36 participants who started the trial completed it. The trial was primarily measuring how the drug and one of its breakdown products moved through the body over time — this is called pharmacokinetics, which is simply the study of how a substance is absorbed, distributed, and cleared by the body. The reported data shows the levels of ABX464 and its main breakdown product (called ABX464-N-Glucuronide) measured in the blood and in certain immune cells (called peripheral blood mononuclear cells, or PBMCs — a type of white blood cell). Two key numbers were tracked for each: the peak concentration (the highest level detected in the body) and the total exposure over time (the overall amount the body was exposed to). For the 150 mg group, the peak blood level of ABX464 was reported as 106.1 ng/mL at one time point and 50.9 ng/mL at another, compared to lower figures in the 50 mg groups. The breakdown product reached much higher levels — for example, a peak of 9,918.2 ng/mL in the 150 mg group versus 1,626.8 and 2,036.2 ng/mL in the two 50 mg groups. Levels measured inside the immune cells were also higher in the 150 mg group than in the 50 mg groups across all reported time points. The reported data shows a pattern where higher doses were associated with higher measured drug levels, and the breakdown product was consistently detected at concentrations much greater than the parent drug itself across all groups. No secondary outcome data was included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT03581305 · results posted 21 March 2023

  According to the results reported on ClinicalTrials.gov, this trial enrolled 23 HIV-positive participants and 23 HIV-negative participants, for a total of 46 people across two separate sub-studies. The trial was measuring how HIV affects two brain chemical systems — dopamine and serotonin — using special brain scans called PET scans. In the dopamine part of the study, participants were injected with a tracer called FDOPA and scanned for 90 minutes. In the serotonin part, a different tracer called 11C-DASB was used in the same way. Not everyone who started finished both parts: in the dopamine study, 20 HIV-positive and 22 HIV-negative participants completed it; in the serotonin study, 18 HIV-positive and 22 HIV-negative participants completed it. The reported data shows the following numbers from the brain scans. For the dopamine study, the key measurement (called the "influx constant" or Ki, which reflects how quickly the FDOPA tracer was taken up in the brain) was reported as 0.01415 per minute for the HIV-positive group and 0.01409 per minute for the HIV-negative group in one brain region, and 0.01588 and 0.01592 per minute respectively in another region. For the serotonin study, the key measurement (called "binding potential," which reflects the availability of a particular serotonin-related protein in the brain) was reported as 2.949 for the HIV-positive group and 3.256 for the HIV-negative group. The reported data shows no numerical results were submitted for the three secondary outcome measures, which looked at links between the scan results and other health factors such as heart disease, HIV infection history, and mood or thinking assessments. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT04330989 · results posted 9 January 2023

  According to the results reported on ClinicalTrials.gov, this trial (NCT04330989) enrolled 300 participants across four groups. Two groups (Group 1a and 1b, with 51 and 49 participants respectively) were people living with HIV who were taking antiretroviral treatment (ART — medication to manage HIV). The other two groups (Group 2a and 2b, with 100 participants each) were people taking PrEP — a medication taken by people who do not have HIV to reduce their chances of getting it. Within each pair, one group received a specialised counselling and support program called "Integrated Next Step Counseling" (iNSC) along with training for a personal adherence supporter, while the other group received standard care. The trial was measuring how many people in each group stayed engaged in their care while also meeting specific medication targets by the end of the study. The reported data shows the following numbers at the end of the study. For the HIV/ART groups: 35 out of 51 participants in the iNSC group had both stayed in care and had very low levels of HIV in their blood (below 40 copies per millilitre, a measure of how much virus is present), compared with 30 out of 49 in the standard care group. Using a slightly less strict virus level threshold (below 1,000 copies per millilitre), 37 from the iNSC group and 35 from the standard care group met that combined target. For self-reported tablet-taking (taking more than 95% of doses in the past 30 days) while staying in care, 37 from the iNSC group and 32 from the standard care group were reported to have met this measure. For the PrEP groups: 22 out of 100 in the iNSC group and 26 out of 100 in the standard care group were reported as staying in care with levels of the PrEP medication in their blood indicating they were taking it consistently. The reported data also shows how well the counsellors delivered the iNSC program, scored on a scale of 0 to 100 (where higher means closer to the intended approach). Counsellors in the HIV/ART group scored an average of 89.3, and those in the PrEP group scored 80.4. Regarding satisfaction with the overall program among those who received iNSC, 42 out of 51 participants in the HIV/ART group and 89 out of 100 in the PrEP group reported being satisfied, with very small numbers (1 and 2 respectively) reporting being somewhat unsatisfied, and none reporting lower satisfaction levels. Nine participants across the two iNSC groups did not provide a satisfaction rating. No satisfaction data was reported for the standard care groups, as those participants did not receive the intervention. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT02924389 · results posted 29 December 2022

  According to the results reported on ClinicalTrials.gov, this trial enrolled 22 people living with HIV who had not yet started antiretroviral (HIV) treatment — 16 males and 6 females. The study was measuring how a HIV medication called dolutegravir moves through the body, specifically how much of it appears in the blood, in certain immune cells, and in rectal tissue. Eight of the male participants did not complete the study, while all six female participants did. The reported data shows the following blood concentration measurements for dolutegravir, combining results across all participants. The highest level of the drug reached in the blood (the "peak" concentration) was reported as 2.01 micrograms per millilitre after the first dose and 2.34 micrograms per millilitre during steady state (when the drug has built up to a stable level with regular dosing). The lowest level in the blood at the 24-hour mark was reported as 0.56 micrograms per millilitre. The time it took to reach that peak level was 1.5 hours after the first dose and 3.0 hours during steady state. The total amount of drug the body was exposed to over 24 hours (a measure called "area under the curve") was reported as 22.30 after the first dose and 27.24 during steady state. For rectal tissue, the reported data shows higher dolutegravir concentrations in participants whose HIV was suppressed compared with those whose HIV was not suppressed, across several measurements. The data for dolutegravir levels in immune blood cells (peripheral blood mononuclear cells) was not reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT02969915 · results posted 22 December 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT02969915) enrolled 2,314 people living with HIV — 1,114 in a group that received financial incentives and 1,200 in a group that received usual care only. The trial was measuring whether offering financial incentives made a difference to the proportion of participants who were both alive and had their HIV virus reduced to very low levels in the blood (below 150 copies per millilitre, which researchers call "viral suppression"). Participants were followed up at 6, 12, and 18 months, though not everyone remained in the study at each check-in point. The reported data shows that, for the primary outcome measured at one of the follow-up points, about 49 in every 100 participants (0.494) in the incentives group were alive with very low virus levels, compared with about 35 in every 100 (0.353) in the usual care group. The reported data also shows similar figures across the additional follow-up time points: the incentives group ranged from roughly 47 to 51 in every 100, while the usual care group ranged from roughly 33 to 37 in every 100. When looking at whether participants had very low virus levels at *any* follow-up visit, the reported figures were about 64 in every 100 (0.640) in the incentives group and about 50 in every 100 (0.498) in the usual care group. For those who had not yet started HIV treatment at the beginning of the trial, the proportion who went on to start treatment was reported as approximately 72 in every 100 (0.721) in the incentives group and 71 in every 100 (0.708) in the usual care group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT03369249 · results posted 22 November 2022

  According to the results reported on ClinicalTrials.gov, this trial involved 307 young adults who were split into two groups: 152 people received an intervention called "Link2CARE" and 155 people received what the trial called "Standard of Care" (that is, the usual support available). The trial was measuring sexual risk behaviour — specifically, how many times participants reported having unprotected anal or vaginal sex over a three-month period — as well as substance use, referrals to substance use treatment, whether participants attended treatment sessions, and whether they accepted or underwent STI (sexually transmitted infection) testing. Most participants completed the study: 135 in the Link2CARE group and 139 in the Standard of Care group. The reported data shows that, for the primary outcome — the number of unprotected sex occasions in the past three months — the Link2CARE group reported an average of 32.76 occasions at one time point and 27.70 at another, while the Standard of Care group reported 44.00 occasions at one time point and 32.76 at another. No further breakdown or explanation of these two time points was included in the submitted data. For all of the secondary outcomes — including substance use frequency, referrals to treatment, treatment attendance, and STI testing — the reported data shows that no numerical results were submitted to ClinicalTrials.gov, so those figures are not available to describe. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02858037 · results posted 25 October 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT02858037) involved 1,456 women and looked at the open-label use of a vaginal ring containing a medicine called dapivirine (25 mg) for HIV prevention. "Open-label" means all participants knew they were using the active ring — there was no placebo or comparison group. The trial measured two main things: any unwanted health events (called adverse events) that occurred while using the ring, and how consistently participants used the ring, which was checked by measuring how much of the medicine remained in returned rings. The reported data shows that, out of the 1,456 women who started the study, 52 experienced what were classified as Grade 2 adverse events (meaning moderate unwanted health events), 19 experienced Grade 3 adverse events (more severe unwanted health events), and 2 experienced serious adverse events. Regarding ring use, the residual (leftover) levels of dapivirine measured in returned rings were consistently around 21.0–21.3 mg across different time points, out of the original 25 mg. The reported data also shows two secondary outcomes: HIV-1 infections occurred at a rate of 2.7 events per 100 person-years (a way of counting how often an event happens across all participants over time), and 6 participants who acquired HIV-1 during the study were found to have drug-resistance mutations associated with dapivirine. It is worth noting that some figures — such as a breakdown of what specific adverse events occurred — were not reported in the data submitted to ClinicalTrials.gov, so those details cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02862171 · results posted 25 October 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT02862171) enrolled 941 women who used a vaginal ring containing 25 mg of a medicine called dapivirine. The ring was inserted monthly, for up to three months, with follow-up visits continuing after that. The trial was measuring two main things: how the ring was tolerated (by tracking any unwanted health events that occurred), and how consistently participants used the ring (by measuring how much of the medicine was left in the ring after it was returned). The reported data shows that, out of 941 participants who started, 848 completed the study and 93 did not. For the safety tracking, the data includes counts of various types of unwanted health events — for example, 616 participants experienced at least one such event of any kind, 37 experienced a more serious category of event (graded 3 or 4, meaning more severe), and 3 experienced what are classified as serious adverse events. Regarding how the ring was used, the amount of medicine remaining in returned rings was consistently reported around 20.5–20.8 mg across different visits and groups — noting that the ring starts with 25 mg, this suggests a similar amount of medicine was released from the ring each month, though the full breakdown of these figures across visits was not separately labelled in the submitted data. For the secondary outcomes, the reported data shows an HIV-1 infection rate of 1.8 events per 100 person-years among participants, and 5 participants who acquired HIV-1 during the study were reported to have HIV drug-resistance mutations detected. It is important to note that this was a single-group, open-label trial — meaning there was no comparison group — so all figures relate only to the women who used the dapivirine ring. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT04223778 · results posted 19 September 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT04223778) enrolled 336 people with HIV in each of two groups — a total of 672 participants. One group switched to a combination of two medicines called doravirine and islatravir (DOR/ISL) straight away, while the other group stayed on their existing HIV treatment for the first 48 weeks before also switching to DOR/ISL. The trial was measuring the level of HIV in participants' blood (called HIV-1 RNA, a way of counting virus particles), as well as tracking any unwanted medical events (called adverse events) that occurred during the study. The reported data shows that at the 48-week mark, 0.0% of participants in the DOR/ISL group had a detectable HIV virus level of 50 copies per millilitre of blood or more, compared with 1.5% in the group that stayed on their existing treatment. Looking at those with virus levels *below* the detectable threshold (under 50 copies/mL), the reported figures were 95.2% for the DOR/ISL group and 94.3% for the continuing-treatment group. By week 96, the reported data shows that 1.2% of the original DOR/ISL group had virus levels at or above 50 copies/mL, with 85.7% below 50 copies/mL; for the group that switched over later, 0.9% were above 50 copies/mL at week 96, with 89.6% below 50 copies/mL. Regarding unwanted medical events up to week 48, 80.1% of the DOR/ISL group reported at least one such event, compared with 70.2% in the continuing-treatment group. The reported data also shows that 2.1% of the DOR/ISL group stopped taking the study medicine because of an adverse event, versus 0.3% in the continuing-treatment group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04223791 · results posted 22 August 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT04223791) compared two HIV medicines taken as daily tablets: DOR/ISL and BIC/FTC/TAF. A total of 322 people were assigned to the DOR/ISL group and 321 to the BIC/FTC/TAF group. The main things the trial measured were: the proportion of participants whose HIV levels in the blood remained detectable (at or above 50 copies per millilitre of blood) at certain points in time, and the proportion who experienced any unwanted medical events (called adverse events) during the study. The base study ran for about 144 weeks (roughly two and three-quarter years), with a smaller extension period beyond that. The reported data shows that at Week 48, approximately 0.6% of the DOR/ISL group and 0.3% of the BIC/FTC/TAF group had detectable HIV levels at or above 50 copies/mL. Looking at it the other way, about 93.8% of the DOR/ISL group and 94.4% of the BIC/FTC/TAF group had HIV levels below 50 copies/mL at that same point. By Week 96, the proportion with detectable levels at or above 50 copies/mL remained low (0.6% DOR/ISL; 0.3% BIC/FTC/TAF), though the data also shows a larger "no data available" category in both groups by that stage. By Week 144, the proportion with levels below 50 copies/mL was reported as 51.9% for DOR/ISL and 65.5% for BIC/FTC/TAF, with the higher "no data" figures reflecting participants who had left the study by that point. Regarding adverse events up to Week 48, the reported data shows that 71.1% of the DOR/ISL group and 74.6% of the BIC/FTC/TAF group experienced at least one unwanted medical event during that period. The proportion who stopped taking their assigned medicine because of an adverse event was 2.5% in both groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04808609 · results posted 18 July 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT04808609) enrolled 40 people in total — 20 in the intervention group and 20 in a control group. All 20 people in the intervention group completed the study, while 17 of the 20 in the control group completed it (3 did not finish). The trial was measuring whether participants stopped smoking over a 12-week period, using both a breath test (measuring a gas called exhaled carbon monoxide, or eCO — lower levels suggest less recent smoking) and self-reported answers about their smoking habits. The reported data shows that, for the main outcome — the proportion of participants who reported no smoking in the 7 days before their 12-week visit *and* had a breath test result confirming this — 15% of the intervention group and 11.8% of the control group met this measure. For a secondary outcome based on self-reporting alone (without the breath test), 30% of the intervention group and 23.5% of the control group reported not smoking in the prior 7 days at 12 weeks. The reported data also shows that average eCO levels dropped slightly in both groups from the start of the study to 12 weeks: the intervention group's average decrease was 3.35 parts per million, and the control group's was 2.12 parts per million. Both groups reported smoking around 11–12 cigarettes per day at the start of the trial, and scores on a depression symptom questionnaire and an alcohol screening tool at the start of the study were also similar between the two groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03275350 · results posted 27 April 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT03275350) enrolled 114 people living with HIV who also had alcohol use disorder — 55 were assigned to receive extended-release naltrexone (a monthly injection sometimes used for alcohol problems, referred to as XR-NTX) and 59 received treatment as usual. The trial ran for 24 weeks and was mainly measuring how many participants had their HIV virus reduced to a very low level in the blood (below 200 copies per millilitre, which researchers call "viral suppression"). The reported data shows that, depending on how missing results were counted, the number of participants with viral suppression at 24 weeks varied. When missing results were counted as "not suppressed," 29 out of 55 in the XR-NTX group and 29 out of 59 in the treatment-as-usual group had suppressed virus at 24 weeks; at the start of the study those numbers were 23 and 21 respectively. When only people with available test results were counted, 26 out of those with data in the XR-NTX group and 26 in the treatment-as-usual group were suppressed at 24 weeks (compared with 23 and 19 at the start). In a stricter analysis limited to people who followed the protocol closely, 15 in the XR-NTX group and 23 in the treatment-as-usual group were suppressed at 24 weeks, compared with 11 and 16 at the start. The reported data also shows results for several secondary measures. A general health score (the VACS Index, where a lower number is considered better, on a scale of 0–164) was 65.1 for the XR-NTX group and 68.4 for the treatment-as-usual group at the start, moving to 54.4 and 63.5 respectively at 24 weeks. A measure of immune cell count (CD4 cells, a marker of immune health) was 380.7 and 439.8 cells/mm³ at the start for each group, rising to 459.1 and 505.1 at 24 weeks. Regarding HIV medications being prescribed, 37 XR-NTX participants and 46 treatment-as-usual participants were prescribed antiretroviral therapy at the start, compared with 45 and 43 at 24 weeks. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT01302847 · results posted 22 March 2022

  According to the results reported on ClinicalTrials.gov, this trial enrolled 181 participants in total, spread across eight separate groups (called cohorts). The groups ranged in size from 7 to 36 people. The trial was measuring how participants responded to a study drug regimen — specifically, it was tracking serious unwanted health events (called "adverse events" graded at level 3 or higher, meaning significant or severe), whether any of those events were linked to the study drug, whether anyone had to permanently stop taking the drug because of such events, whether anyone died, and how the drug moved through the body over a 24-hour period (a measurement known as drug exposure in the bloodstream). The reported data shows that the percentage of participants experiencing serious adverse events varied considerably across the eight groups. In some groups the figures were relatively low — for example, 4.3% in Cohort I and 6.7% in Cohort IIB — while in others they were much higher, reaching 57.1% in Cohort IV and 60% in Cohort V-DT. When looking only at serious adverse events considered to be related to the study drug, the reported data shows that nearly all groups recorded 0%, with the exception of Cohort IV, where 14.3% was reported. The reported data also shows that no participant in any group permanently stopped taking the study drug due to a drug-related adverse event. Two deaths were recorded across all groups — one each in the Cohort III-DT and Cohort IV-DT groups — and none in the remaining six groups. For the drug exposure measurement (how much of the drug was in the bloodstream over 24 hours), figures ranged from approximately 52.98 to 82.67 hr\*mg/L across the five cohorts where this was measured. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT04426656 · results posted 2 March 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT04426656) involved 70 participants in total across two groups. Twenty-four people were placed in a "standard of care" group and 46 used a smartphone mini-app. The trial was measuring things related to PrEP — a medication taken to reduce the chance of acquiring HIV — specifically whether participants intended to start using it, whether they actually did start, and where they sat in a five-stage readiness process (ranging from "no interest at all" through to "regularly taking PrEP"). The reported data shows that when participants were asked to rate their intention to start PrEP on a scale from -3 to +3, the standard of care group's average score changed by +0.19, +0.57, and +1.00 at three separate measurement points across the study, while the mini-app group's scores changed by 0.00, -0.09, and -0.40 at those same points. Regarding who actually reported starting PrEP by week 8, the reported data shows 5 out of 24 participants in the standard of care group and 8 out of 46 in the mini-app group did so. The readiness-stage data shows how participants were spread across the five stages (from "no interest" to "staying on PrEP") at the start of the study and at weeks 4, 8, and 12 — for example, by week 12, 8 people in the standard of care group and 17 in the mini-app group were still in the "no interest" stage, while 5 in each group were reported as being in the "action" or "maintenance" stages. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT02568215 · results posted 8 February 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT02568215) enrolled 1,924 people across three groups: 637 received a placebo (inactive infusion), 642 received a lower dose of an antibody called VRC01, and 645 received a higher dose of VRC01. The trial was measuring reactions and body changes that occurred after participants received their infusions — specifically looking at local reactions at the injection site (such as pain, tenderness, redness, and swelling), whole-body symptoms (such as fatigue, headache, nausea, and muscle aches), and routine blood test results. Around 558–562 people in each group completed the study. The reported data shows that for injection-site pain or tenderness, the large majority of participants across all groups reported either no symptoms or mild symptoms. For example, 476 placebo participants, 496 low-dose, and 506 high-dose participants reported mild or no pain, while more noticeable (higher-grade) reactions were recorded in smaller numbers — 19, 26, and 16 participants respectively in the most severe category tracked. For redness or swelling at the injection site, the numbers with higher-grade reactions were even smaller across all groups. For whole-body symptoms, the reported data shows most participants fell into the lower-severity categories, with 473, 487, and 495 participants respectively in the mildest category, and 30, 33, and 42 in the highest category. Routine blood test results — including a liver enzyme (ALT), kidney marker (creatinine), and haemoglobin (a measure of red blood cells) — were reported as median values and appeared broadly similar across all three groups and across the different time points measured. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02716675 · results posted 8 February 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT02716675) enrolled 2,699 participants across three groups: 903 received a placebo, 899 received a low dose of an antibody called VRC01, and 897 received a high dose of VRC01. The trial was measuring how people's bodies responded to the injections — specifically looking at reactions at the injection site (such as pain, tenderness, redness, or swelling), general body symptoms (such as tiredness, headache, muscle aches, nausea, and chills), and routine blood test results. Around 703–703 people in each group completed the study, with roughly 197–211 per group not completing it. The reported data shows that when it came to pain or tenderness at the injection site, the large majority of participants across all groups reported either no symptoms or only mild symptoms — for example, 812 placebo participants, 794 low-dose, and 805 high-dose participants reported grade 1 (mild) pain or tenderness, while only 1, 1, and 4 participants respectively reported a grade 3 (more severe) level. For redness or swelling, most participants again fell into the mild or no-symptom category, with very small numbers (9, 8, and 2 across the three groups) recording a grade 3 response. For general body symptoms like fatigue, headache, or muscle aches, the reported data shows 664, 672, and 691 participants in each group respectively had grade 1 (mild) symptoms, while 39, 45, and 36 had grade 3 symptoms. Routine blood test results — including liver enzyme levels (ALT), kidney function (creatinine), and red blood cell levels (haemoglobin) — were reported as median values and appeared broadly similar across all three groups at each measurement point, with no notable numerical differences reported between placebo and VRC01 groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT03350672 · results posted 30 September 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT03350672) enrolled 37 people across three groups. Ten participants each were placed in "Cohort 1a" (single-dose group) and "Cohort 1b" (seven-dose group), and 17 were enrolled in "Cohort 2" (people already living with HIV on a tenofovir-based tablet), of whom 10 completed the study. The trial was measuring how a substance called tenofovir (TFV) — a component of a HIV medication — showed up in morning urine samples over several days, and at what levels. Specifically, it was tracking how many urine samples contained tenofovir at or above a set concentration (1,000 nanograms per millilitre) to understand how long the drug could be detected after doses were taken. The reported data shows the following results for each group. In Cohort 1a (one dose only), the percentage of urine samples meeting the concentration threshold dropped over seven days of collection: 60% on days one and two, falling to 30% on day three, 20% on day four, 0% on days five and six, and 10% on day seven. In Cohort 1b (seven doses), the percentages across ten days of collection were: 100% on day one, then 80% on days two, three, and four, dropping to 30% on days five and six, 20% on days seven and eight, and 0% on days nine and ten. For Cohort 2 — people living with HIV already taking the medication regularly — the reported data shows that 100% of the single urine samples collected met the concentration threshold. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04109443 · results posted 14 September 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT04109443) looked at whether an online program called "Young Men & Media" was practical and feasible to run — not whether it treated or cured anything. A total of 154 young men were enrolled and split into two groups: 77 received the online media literacy program, and 77 were in a control group (meaning they did not receive the program). Of those who started, 67 in the program group and 65 in the control group finished the study, with 10 and 12 participants respectively not completing it. The reported data shows several practical (feasibility) measures. Out of 422 people who were initially screened online as eligible, 154 enrolled, giving an overall recruitment rate of 36.5%. For the number of participants who completed all of the program's online content, 38 people in the program group did so, while the figure for the control group was reported as zero (as expected, since they did not receive the content). Participant satisfaction with the program content was rated on a 1-to-5-star scale, and the reported average rating was 4.3 out of 5 for the program group. Across both groups combined, 126 out of 154 enrolled participants completed all of the study's assessments. The reported data shows that some other measures — including the banner advertisement click-through rate and the time participants spent on the program content — were not provided in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT03422172 · results posted 13 May 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT03422172) enrolled 48 adults who received a medication called cabotegravir. The trial was set up to track what happened to participants over several stages: a four-week period taking cabotegravir as a daily tablet, a short washout period, a longer injection phase lasting roughly nine months, and then a follow-up period. By the end of the injection phase, 43 of the original 48 participants had completed that stage and went on to complete follow-up as well. The trial was primarily measuring things like unwanted medical events (called adverse events), changes in blood and urine test results, and changes in vital signs such as blood pressure and pulse rate. The reported data shows that during the injection phase, 47 out of 47 participants who received the injections experienced at least one non-serious adverse event, and 1 out of 47 experienced a serious adverse event — that is, one that the researchers considered potentially significant (such as something requiring hospitalisation or considered life-threatening). No participants were withdrawn from the trial because of an adverse event. For blood test results, the reported data shows that most participants stayed at the lowest severity level (Grade 0, meaning no notable change) across the various blood and urine measurements tested, with a small number showing mild changes in some chemistry measures (6 out of 47 recorded a mild Grade 1 change in at least one chemistry value). For vital signs like blood pressure and pulse rate, the reported data shows that 46 out of 47 participants either stayed in the normal range or showed no meaningful change, with 1 participant recorded as shifting outside the normal range for each vital sign measure. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT03242954 · results posted 22 April 2021

  According to the results reported on ClinicalTrials.gov, this trial involved 254 participants in total — 129 adolescents and 125 parents. The adolescents were split into three groups, each shown a different type of consent arrangement (called Consent Conditions 1, 2, and 3) for hypothetical HIV-related research studies. The trial was measuring two things: how willing adolescents said they would be to join a research study (called their "Willingness to Participate" score), and how acceptable parents found each consent arrangement (called their "Willingness to Support" score). All scores were recorded on a 1-to-5 scale, where 1 meant definitely not and 5 meant definitely yes. Every single participant who started the study also completed it — there were no dropouts reported. The reported data shows that adolescent willingness scores were fairly similar across all three consent conditions, sitting at 3.7, 3.7, and 3.5 out of 5 respectively — roughly in the middle of the scale, around the "might or might not participate" to "probably participate" range. When broken down by the type of hypothetical study they were shown, the scores remained similarly close together, ranging from 3.4 to 3.8. For parents, the reported data shows their scores varied more noticeably depending on the consent condition: 2.6 out of 5 for the condition where adolescents could consent on their own (closer to "disagree" that this was acceptable), 3.1 for the condition requiring an adult's permission (around neutral), and 4.4 for the condition requiring a parent's specific permission (closer to "strongly agree"). A similar pattern appeared when parents rated how acceptable each approach was for the two different hypothetical study types. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT02390908 · results posted 12 April 2021

  According to the results reported on ClinicalTrials.gov, this trial involved 294 people in total across five groups. Three groups (across three different clinic sites, totalling 84 people) received an intervention called "PLUS" straight away; a fourth group of 90 people was placed on a waiting list before receiving the same intervention; and a fifth group of 120 people served as a comparison group whose information was drawn from medical records only, with no intervention offered. All 294 participants completed the study — the reported data shows no drop-outs in any group. The trial was measuring several things related to HIV care and alcohol use: the level of HIV in participants' blood (viral load), a measure of immune system health (CD4 count — the number of a particular type of immune cell), how consistently people took their HIV medication (adherence), and how severe their alcohol use was. The reported data shows the following results at the end of the study. For HIV viral load — measured on a mathematical scale used to handle the wide range of values — the three immediate-intervention groups recorded average scores of 3.1, 1.8, and 1.8, while the waiting-list group averaged 2.6 and the no-intervention comparison group averaged 2.5 (lower numbers on this scale mean less HIV detected in the blood). For CD4 immune cell counts, the three intervention groups averaged 632, 696, and 391 cells per cubic millimetre respectively, compared with 398 and 409 in the waiting-list and comparison groups. For medication adherence, the three immediate-intervention groups reported taking their HIV medication on approximately 85%, 87%, and 83% of days in the past month, while the waiting-list group reported around 78% — the no-intervention comparison group's adherence was not reported for this measure. For alcohol use severity (scored 0–40, where higher means more severe), the three intervention groups scored an average of 10.4, 3.3, and 9.1, while the waiting-list group scored 5.9 — again, this measure was not reported for the comparison group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01266902 · results posted 4 March 2021

  According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called rilpivirine (also known as RPV) for people living with HIV. The trial ran across two main periods and involved participants from several related studies. In the first period, 119 people were in one group and 363 were in another; 89 and 282 of those respectively completed that period. A smaller third group of 45 people took part in a second period after the study rules were updated, and 37 of them completed it. The trial was primarily measuring how many participants experienced any unwanted medical events (called adverse events) while taking rilpivirine, and also tracked a range of other measures over a long follow-up period of up to around six and a half years. The reported data shows that for the primary outcome — the number of participants who experienced any adverse event — 32 out of 119 people were recorded in the first group, and 70 out of 363 in the second group. For serious adverse events (those involving hospitalisation, life-threatening situations, lasting disability, or death), the reported numbers were 9 in the first group and 14 in the second. The trial also tracked how long it took for the virus level in the blood to bounce back above certain thresholds; the reported average time to that point was around 1,671 days for the first group and around 1,939 days for the second group (for one threshold), though the data notes these averages are likely underestimates due to the way the study ended. Changes in a measure of immune cell levels (CD4+ cells, which reflect how the immune system is holding up) were also recorded at various time points across both groups, with the reported figures showing varying degrees of change from the starting point across the years of follow-up. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03308097 · results posted 21 February 2021

  According to the results reported on ClinicalTrials.gov, this trial enrolled 65 people in total — 33 in a group that received a mobile phone messaging program about PrEP (a medication taken to reduce the chance of getting HIV), and 32 in a group that received an enhanced standard of care. Almost all participants finished the study: 31 in each group completed it. The trial was measuring things like how often participants attended PrEP-related clinic appointments, how many received a PrEP prescription within 16 weeks, and whether their knowledge about PrEP changed over that time. The reported data shows that, when looking at clinic appointment attendance across all participants (the "full sample"), the mobile messaging group attended an average of 0.58 visits and the standard care group attended an average of 0.55 visits. When looking only at participants who had not already received a PrEP prescription on the day they joined the study (the "restricted sample"), those figures were 0.56 and 0.50 visits respectively. For PrEP prescriptions in the full sample, the reported data shows 16 people in the messaging group and 17 in the standard care group received a prescription; in the restricted sample, 11 in the messaging group and 10 in the standard care group received one. Regarding PrEP knowledge, participants were scored on a scale of 0 to 3. The reported data shows that in the full sample, the messaging group's score increased by an average of 0.50 points and the standard care group's score increased by 1.00 point; in the restricted sample, the increases were 0.55 and 0.83 points respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02797171 · results posted 8 January 2021

  According to the results reported on ClinicalTrials.gov, this trial enrolled 80 participants across six groups — five groups received different versions or doses of a vaccine (totalling 79 people), and one small pre-treatment comparison group had 1 person. The trial was measuring reactions at the injection site (local reactions), reactions felt throughout the body (systemic reactions such as fatigue or fever), and a range of standard blood and chemistry test results. In total, 68 of the 80 participants completed the study, with 12 not completing it across the various groups. The reported data shows that, for local reactions at the injection site, the number of participants who experienced any such reaction ranged from 0 to 19 across the five vaccine groups, with most reactions recorded as lower severity grades. For body-wide reactions, the reported data shows between 6 and 18 participants per vaccine group experienced some level of systemic reaction, again mostly at lower severity grades. A small number of participants in some groups had reactions recorded at higher severity grades, though the full breakdown of all categories was not completely reported in the submitted data. The reported data also shows that standard blood test results — including liver-related measures, kidney function, red and white blood cell counts, and platelets — were recorded across all groups throughout the trial. According to the results reported on ClinicalTrials.gov, no participants in any group (including the pre-treatment group) recorded a blood test result above "Grade 1" on a standard medical severity scale, meaning all values remained within the lower range of the scale used. Some individual average blood test figures were reported for each group, but a full set of figures for every group was not provided for all measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00679926 · results posted 4 December 2020

  According to the results reported on ClinicalTrials.gov, this trial enrolled 15 participants, all placed in a single treatment group. The study was designed to look at how well a once-daily combination of two HIV medicines — Viread (300mg) and Kaletra (800mg/200mg) — could reduce the amount of HIV in the blood of people who had never previously been treated for HIV. The trial was planned to run for 48 weeks. Of the 15 people who started, only 2 completed the study, while 13 did not finish. The reported data shows that, unfortunately, no numerical results were submitted to ClinicalTrials.gov for any of the outcome measures — neither the primary measure (the proportion of participants whose HIV levels in the blood dropped below 50 copies per millilitre at 48 weeks) nor any of the secondary measures (such as changes in CD4 counts, which are a type of immune cell used to track HIV's effect on the body, or the time it took for the treatment to stop working). Because so few participants completed the trial and no measurement data was provided in the submission, the specific numbers for these outcomes were not reported. Given that most participants did not finish the study and that no outcome figures were submitted, the results as registered provide very limited information about what was observed during the trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02778204 · results posted 23 November 2020

  According to the results reported on ClinicalTrials.gov, this trial (NCT02778204) looked at how the HIV medication maraviroc behaves in the bodies of children and teenagers. A total of 47 young participants took part, split into four groups based on their age and whether they had already been taking HIV medicines. The groups were labelled Cohort 1 Stratum 1A (8 participants), Cohort 1 Stratum 1B (7 participants), Cohort 2 Stratum 2A (16 participants), and Cohort 2 Stratum 2B (16 participants). The trial was primarily measuring two things: whether serious unwanted events (side effects) occurred that were linked to the study drug, and whether the amount of the drug in the blood reached a target level considered sufficient based on adult studies. The reported data shows that, across all four groups, zero participants (0%) experienced the types of serious unwanted events that were defined as a "failure" on the safety measure — meaning none met the criteria for life-threatening reactions, severe side effects probably or definitely linked to the drug, or having to permanently stop the drug because of a side effect. For the blood-level (drug concentration) target, the reported data shows that in Cohort 1 (both groups), zero participants fell below the target blood level. In Cohort 2, the reported numbers of participants who did not reach the target blood level varied across two measurement visits: in Stratum 2A, 3 and then 4 participants fell below the target; in Stratum 2B, 4 and then 5 participants fell below it. The reported average drug concentrations in the blood ranged from around 94 to 375 nanograms per millilitre depending on the group and time point measured. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02777086 · results posted 19 October 2020

  According to the results reported on ClinicalTrials.gov, this trial involved 511 people in total — 261 in a group called "StaySafe" and 250 in a "Comparison" group. The trial was measuring knowledge, confidence, and motivation across four areas related to HIV: general HIV knowledge, avoiding risky sexual behaviour, accessing HIV testing and services, and risk reduction skills. Each area was measured using a questionnaire scored on a scale from 10 to 50, where a higher number means greater knowledge, confidence, and motivation in that area. The reported data shows that across all four areas, the StaySafe group recorded slightly higher average scores than the Comparison group at the end of the study. For general HIV knowledge, the StaySafe group scored 42.9 compared to 40.5 for the Comparison group. For avoiding risky sexual behaviour, the scores were 43.1 versus 41.3. For HIV testing and services, the scores were 44.3 versus 42.1. For risk reduction skills, both groups scored relatively closely — 44.3 for StaySafe and 43.0 for the Comparison group. It is worth noting that of the 511 people who started the trial, 165 in the StaySafe group and 151 in the Comparison group completed it, meaning a notable number of participants did not finish. The reported data does not include any further detail about why participants left the study early, and no additional outcome figures beyond these questionnaire scores were included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT03076359 · results posted 29 September 2020

  According to the results reported on ClinicalTrials.gov, this trial involved 320 people living with HIV — 170 in a "Standard of Care" group (receiving usual HIV treatment and support) and 150 in a "Traditional Healer Support Program" group (who received additional support involving traditional healers alongside usual care). All 320 participants completed the study. The trial was measuring two things: how consistently participants had access to their HIV medication over time (called "retention in care"), and the level of HIV in their blood (called "viral load") at 12 months. The reported data shows that for medication coverage — meaning the percentage of days a person had their medication available to them — the Standard of Care group recorded 80% and the Traditional Healer Support Program group recorded 79%. For viral load at 12 months, both groups recorded a result of −20 copies per millilitre of blood. According to the researchers' notes in the data, a negative value in this particular test means no HIV was detected in the blood at that measurement point, which is how results below the detectable threshold are recorded using the testing method used in the region. The reported data shows these figures as the end results of the study; no information about how the numbers changed over time was reported in the submitted data. If any other outcome details were collected but not included in the submitted results, they were not reported and cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03616106 · results posted 3 September 2020

  According to the results reported on ClinicalTrials.gov, this trial (NCT03616106) involved 56 patient participants and 3 interventionists (the people delivering the program). Of the patient participants, 42 completed the study and 14 did not finish. The trial was measuring two things in the patient group over time: CD4 count (a measure of certain immune cells in the blood, counted per cubic millimetre) and viral load (the amount of virus detected in the blood, measured in copies per millilitre). These were recorded at the start of the study (baseline) and then again at 3, 6, and 9 months. The reported data shows the following CD4 count figures for patient participants: the starting (baseline) average was 385.86 cells/mm³, which changed to 373.69 at 3 months, 414.41 at 6 months, and 445.42 at 9 months. For viral load, the reported starting average was 84,326 copies/mL. The reported data shows this figure was 81,470 at 3 months, 91,590 at 6 months, and 45,581 at 9 months. The trial was looking at the association — that is, the relationship — between these baseline figures and the later measurements at each time point. It is worth noting that the submitted results do not include any statistical detail about the strength or significance of those associations, so those figures were not reported and cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT03751020 · results posted 28 August 2020

  According to the results reported on ClinicalTrials.gov, this trial enrolled 108 people in total — 36 in each of three groups: a Control group, an Expressive Writing group (where participants wrote about their thoughts and feelings), and a Self-Affirmation group (where participants wrote about their personal values). The trial was looking at whether these writing exercises made a difference to depression, psychological distress, anxiety, thoughts of suicide, alcohol use, and drug use, measured at the start of the study, shortly after the writing sessions ended, and again three months later. Not everyone finished the study — by the three-month follow-up, 27 people remained in the Control group, 32 in the Expressive Writing group, and 26 in the Self-Affirmation group. The reported data shows the following average scores across the three time points (start, post-intervention, and three-month follow-up). For depression (scored 0–60, higher meaning more symptoms): the Control group scored 24.75, 21.03, and 23.44; the Expressive Writing group scored 25.17, 17.42, and 18.45; and the Self-Affirmation group scored 29.06, 21.73, and 22.92. For psychological distress (scored 0–4): the Control group scored 2.31, 1.84, and 2.14; the Expressive Writing group scored 2.22, 1.82, and 1.77; and the Self-Affirmation group scored 2.63, 2.08, and 2.35. For anxiety (scored 0–63): the Control group scored 21.72, 14.73, and 18.26; the Expressive Writing group scored 20.28, 13.54, and 13.03; and the Self-Affirmation group scored 26.94, 19.47, and 19.73. For suicidal thoughts (scored 0–50): the Control group scored 6.05, 2.36, and 4.63; the Expressive Writing group scored 4.19, 1.21, and 3.87; and the Self-Affirmation group scored 9.42, 2.70, and 5.31. The reported data also shows scores for alcohol use (scored 0–40, higher meaning more hazardous drinking): the Control group scored 5.08, 4.67, and 5.26; the Expressive Writing group scored 4.25, 3.70, and 2.91; and the Self-Affirmation group scored 5.97, 3.73, and 5.58. For drug-related problems (scored 0–15): the Control group scored 0.39, 0.36, and 0.33; the Expressive Writing group scored 0.31, 0.67, and 0.84; and the Self-Affirmation group scored 1.47, 0.57, and 1.58. These numbers are the average scores for each group at each time point as submitted to the registry; no further breakdown of the results was reported in the structured data available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT02128828 · results posted 20 August 2020

  According to the results reported on ClinicalTrials.gov, this trial enrolled 20 adults, all of whom received a treatment called cenicriviroc. Of the 20 who started, 17 completed the study and 3 did not finish. The trial was measuring whether there was any change in overall brain and thinking (neuropsychological) performance after 24 weeks of treatment. To do this, participants completed 14 standardised thinking and memory tests, and their scores were combined into a single overall score called the NPZ-Global score. The reported data shows that, on average, participants' NPZ-Global scores changed by +0.24 units from the start of the study to week 24. To put this number in context, the scoring system used is designed so that a score of 0 represents average performance for a person of similar age, sex, and education — and a difference of 1.0 unit up or down represents one full "standard deviation" (that is, one large step away from the average). The reported change of +0.24 is therefore a relatively small shift in the positive direction on this scale. It is worth noting that the trial only had one group — there was no separate comparison or placebo group reported in the submitted data. The reported data does not include a separate comparison group result, a measure of how much individual results varied, or information about whether this change was considered statistically meaningful (that is, unlikely to be due to chance). Those figures were not included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00925756 · results posted 19 August 2020

  According to the results reported on ClinicalTrials.gov, this trial enrolled 32 adults, all of whom completed the study — none dropped out. All participants received a treatment called maraviroc as an "intensification" add-on, meaning it was added to their existing HIV therapy. The trial was primarily looking at changes in gene activity (how genes in certain immune cells switch on or off) over time, and also tracked changes in immune cell counts and markers of immune cell behaviour at the start of the study, then again at 4 weeks and 24 weeks. The reported data shows that the main (primary) outcome measured changes in the activity of a signalling molecule called TNF across the study period. The result was reported as a 1.44-fold downregulation of TNF — in plain terms, this means TNF activity appeared to decrease by roughly one and a half times compared to the starting point, as measured across the gene analysis. For the secondary outcomes, the reported data shows changes in CD4+ immune cell counts (a type of white blood cell important in immune function). The figures reported included values of 6.50, 46, 36.75, and 100.00 cells per cubic millimetre at various time points, though the data as submitted does not clearly label which number belongs to which time point. A separate secondary measure looked at changes in various immune cell markers, with reported values ranging from around −0.47 to +1.12, though again the submitted data does not clearly match each number to a specific marker or time point. It is worth noting that some details — such as exactly which time point or marker each individual number corresponds to — were not clearly distinguishable in the data as reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02833844 · results posted 21 July 2020

  According to the results reported on ClinicalTrials.gov, this trial enrolled 467 participants across two groups. One group of 157 people received a placebo (a dummy injection) during the first, blinded phase of the study, before switching to the active medicine — evolocumab — in a second open-label phase (where everyone knew what they were receiving). The other group of 310 people received evolocumab throughout both phases. The trial was primarily measuring changes in LDL cholesterol — often called "bad" cholesterol — in the blood after 24 weeks. It also tracked several related measures, including the proportion of participants who reached a commonly referenced cholesterol level and changes in other blood fats. The reported data shows that, at week 24, the placebo group's LDL cholesterol level had changed by approximately +1.68% from their starting point, while the evolocumab group's LDL cholesterol had changed by approximately −55.23% from their starting point. In everyday units (mg/dL, a standard way of measuring cholesterol in blood), the placebo group saw a change of −2.3 mg/dL, compared with −77.5 mg/dL in the evolocumab group. For the secondary measures, the reported data shows that 7.9% of placebo participants and 73.3% of evolocumab participants reached an LDL level below 70 mg/dL at week 24. Additionally, 0.7% of placebo participants and 72.5% of evolocumab participants had their LDL cholesterol reduced by 50% or more from their starting level. Changes in other blood fats — non-HDL cholesterol and apolipoprotein B (a protein linked to cholesterol transport) — also showed larger percentage reductions in the evolocumab group (−48.07% and −45.14% respectively) compared with the placebo group (+2.86% and +2.59% respectively). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00752856 · results posted 7 July 2020

  According to the results reported on ClinicalTrials.gov, this trial enrolled 51 people in total — 26 in one group taking a combination of Kaletra and Isentress twice daily, and 25 in a second group taking Atripla once daily. All 26 people in the first group and 24 of the 25 in the second group completed the study (one person in the Atripla group did not finish). The trial was looking at how quickly HIV levels in the blood dropped in the early days after starting treatment, and also tracked longer-term outcomes at 48 weeks (roughly one year). The reported data shows that in the first two weeks of treatment, the speed at which HIV levels fell — measured in units called log(10) per day, which is simply a way of expressing how steeply the virus count was declining — was 0.47 for the Kaletra/Isentress group and 0.55 for the Atripla group. For the 48-week outcome, the reported data shows that 86% of participants in the Kaletra/Isentress group and 87.5% in the Atripla group had HIV levels that had dropped to an undetectable level in their blood. The trial also tracked a type of immune cell called CD4+ T-cells, which are part of the body's defence system. From the start of the trial to week 4, the average change in these cells was −3.81 cells/mm³ in the Kaletra/Isentress group and −1.18 cells/mm³ in the Atripla group. From the start to week 48, the reported average change was −2.24 cells/mm³ and −5.65 cells/mm³ respectively. The trial did not report on what these specific differences might mean clinically. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT01944371 · results posted 5 May 2020

  According to the results reported on ClinicalTrials.gov, this trial enrolled 30 people in total, divided equally into three groups of 10. Each group received a different daily dose of a drug called disulfiram — either 500 mg, 1,000 mg, or 2,000 mg — for three days. All 30 participants completed the study. The trial was measuring whether disulfiram had any effect on the amount of HIV found in certain immune cells (called CD4 T-cells), in the blood, and stored in the DNA of cells, in people who were already on standard HIV treatment. The reported data shows the main thing being measured was the change in HIV activity inside CD4 T-cells, expressed as a "fold change" — meaning how many times higher the level was compared to the starting point (a fold change of 1.0 would mean no change). The reported figures were 1.7-fold for the 500 mg group, 1.9-fold for the 1,000 mg group, and 1.6-fold for the 2,000 mg group. For HIV detectable in the blood (plasma), the reported fold changes from the starting point to day 3 were 1.50, 0.90, and 1.22 for the three dose groups respectively. For HIV stored in cell DNA, measured from the start to day 30, the reported fold changes were 1.07, 0.83, and 0.91 across the three groups. The trial also tracked how much disulfiram was absorbed into the bloodstream over 72 hours, with higher doses producing higher measured levels (3,186, 8,386, and 22,331 mg-hour/litre for the 500 mg, 1,000 mg, and 2,000 mg groups respectively). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01548599 · results posted 14 April 2020

  According to the results reported on ClinicalTrials.gov, this trial enrolled 140 people living with HIV in Kenya — 72 in the intervention group (which involved a multi-sectoral agricultural programme) and 68 in a control group that did not receive the intervention. The trial measured two main things after one year: how many participants had very low levels of HIV in their blood (known as viral suppression, meaning fewer than 40 copies of the virus per millilitre of blood), and how much a key immune cell count — called a CD4 count, which gives a rough picture of immune system health — changed over that time. A number of secondary measures were also tracked, including food consumption, food insecurity, sexual risk behaviour, and household food spending. The reported data shows that, at the one-year mark, 52 out of 66 participants who completed the intervention arm had HIV viral levels below the 40 copies/mL threshold, compared with 44 out of 66 in the control arm. For CD4 counts, the intervention group showed an average increase of about 81 cells per microlitre from their starting point, while the control group showed an average decrease of about 89 cells per microlitre. On the secondary measures, the reported data shows the intervention group's food consumption score increased by around 9.6 units compared with near zero (0.18) in the control group; food insecurity scores (where a higher number means worse insecurity) fell by about 7.4 points in the intervention group and 3.7 points in the control group; weekly household food spending rose by an average of 304 Kenyan shillings in the intervention group versus 84 shillings in the control group; and approximately 1.85% of intervention participants reported unprotected sex with an HIV-negative or unknown-status partner, compared with 3.13% in the control group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02067039 · results posted 31 March 2020

  According to the results reported on ClinicalTrials.gov, this trial involved 2,665 men who have sex with men (MSM) recruited online. They were divided into two groups: 1,325 people in the "self-testing" group, who were given access to HIV self-test kits, and 1,340 people in the "information only" (control) group, who received information about HIV testing but not self-test kits. The trial followed participants over 12 months and measured things like how often people tested for HIV, whether those who got a positive result then sought further care, and how many new HIV infections were identified across both groups. The reported data shows that for the main outcome — the number of people who tested for HIV three or more times over the 12 months — 777 participants in the self-testing group reached that level of testing, compared with 215 in the information-only group. For the secondary outcomes, 16 people in the self-testing group reported a positive result on a rapid HIV test, and of those, 9 went on to access follow-up testing or care services; in the information-only group, 10 people reported a positive rapid test result, and 1 went on to access follow-up services. Regarding newly identified HIV infections overall (from either self-testing or provider testing), 25 were reported in the self-testing group and 11 in the information-only group. The trial also tracked a separate group of 2,150 people in the social networks of self-testing participants; the reported data shows 34 of those network members reported a positive HIV self-test result. No comparison figure for the control group's social network was reported in the data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT02140775 · results posted 16 March 2020

  According to the results reported on ClinicalTrials.gov, this trial involved 116 people in total — 87 were placed in a group receiving a type of counselling called Behavioural Activation (BA) Counselling, and 29 received Supportive Counselling (SC). The trial was measuring whether participants reached a personal, work-related goal they had set before the counselling began, as well as tracking changes in their activity levels and daily engagement using two questionnaire-based scales. Not everyone finished the trial: 57 out of 87 people completed the BA Counselling group, and 22 out of 29 completed the Supportive Counselling group. The reported data shows that, for the main goal of the trial — whether participants fully achieved their pre-set work-related goal — 29 out of the BA Counselling participants were recorded as having reached their goal, compared with 9 out of the Supportive Counselling participants. For the two secondary measures, the reported data shows average scores on a scale measuring environmental reward (how much positive reinforcement people experienced in daily life, scored 10–40) were 27 for the BA Counselling group and 31 for the Supportive Counselling group. On a second scale measuring activation and engagement in daily life (scored 0–150, where higher scores suggest more activity and less avoidance), the BA Counselling group scored an average of 99 and the Supportive Counselling group scored an average of 102. It is worth noting that the numbers reported for the secondary scales appear to reflect average scores across the groups, though the data submission did not include full details such as the number of participants contributing to each average or results broken down over time. Where such details were not included in the submitted data, they have not been described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01011413 · results posted 21 February 2020

  According to the results reported on ClinicalTrials.gov, this trial compared two different doses of a HIV medication called efavirenz — the standard 600mg dose and a lower 400mg dose — in people living with HIV. A total of 636 people joined the study (312 in the 600mg group and 324 in the 400mg group), with 630 of these going on to actually take the study medication. The trial's main goal was to measure what proportion of participants had very low levels of HIV in their blood (fewer than 200 copies per millilitre) at 48 weeks after starting treatment. The reported data shows that at the 48-week mark, 92.2% of participants in the 600mg group and 94.1% in the 400mg group had HIV levels below that threshold. For secondary measurements — things the trial also tracked but were not the main focus — the reported data shows that average CD4+ T-cell counts (a measure of immune system status) increased from the start of the trial by around 209 cells per cubic millimetre in the 600mg group and 235 cells per cubic millimetre in the 400mg group by week 96. Changes in blood cholesterol and glucose levels were also recorded over 96 weeks, with both groups showing modest increases across most of these measures; specific figures varied slightly between the two groups. Numbers of participants who experienced serious illness or died were also tracked and reported across both groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT01041521 · results posted 11 February 2020

  According to the results reported on ClinicalTrials.gov, this trial enrolled 61 people in the omega-3 fatty acid (Lovaza) group and 56 people in the sugar pill (placebo) group. Of those, 44 people in the Lovaza group and 40 in the sugar pill group completed the study. The trial was measuring two things: levels of triglycerides (a type of fat found in the blood) and vascular function (how stiff or flexible the blood vessels are). The reported data shows that, at the end of the study, the average triglyceride level in the Lovaza group was 130 mg/dL (milligrams per decilitre, a standard unit for measuring substances in blood), compared with 159 mg/dL in the sugar pill group. For vascular function, the trial used a test called carotid-femoral pulse wave velocity, where a lower number indicates less stiffness in the arteries. The reported data shows the Lovaza group recorded an average of 833 metres per second and the sugar pill group recorded 832 metres per second — figures that were very close to each other. No other outcome data was reported in the submitted results. It is worth noting that these numbers are averages reported for each group and do not tell us about any individual person's experience during the trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02970552 · results posted 6 February 2020

  According to the results reported on ClinicalTrials.gov, this trial enrolled 140 pregnant women living with HIV who were considered at risk of giving birth early (preterm birth). They were split into two equal groups of 70 — one group used a vaginal progesterone gel and the other used a placebo (a dummy gel with no active ingredient). The trial was primarily designed to test whether participants could reliably use the gel as instructed — not to measure pregnancy outcomes — and it also gathered information through interviews and surveys about participants' attitudes and experiences with the study. The reported data shows that when it came to the main measure — taking at least 80% of the prescribed doses correctly, checked by testing returned applicators — 62 out of 67 participants in the vaginal progesterone group and 63 out of 67 in the placebo group met this target. For the secondary measures, a subset of participants took part in interviews: 19 from the progesterone group and 11 from the placebo group reported on barriers and facilitators to using the gel. Regarding attitudes toward taking a vaginal medication to prevent preterm birth, 66 out of 67 progesterone-group participants and 60 out of 67 placebo-group participants selected the most positive response option on the satisfaction survey. When asked about the hardest part of taking the medication, the large majority in both groups — 66 in the progesterone group and 62 in the placebo group — selected the response indicating no particular difficulty. Some secondary outcome data from the interviews was not fully reported in the structured results submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT02440789 · results posted 30 December 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 32 participants, all of whom were in a single group receiving a drug called sirolimus. The trial was measuring two broad things: first, whether the drug was associated with certain serious side effects or a significant drop in a key immune cell (called a CD4+ cell, which helps the body fight infection); and second, whether the drug had any effect on markers of HIV activity in the blood and immune cells. Thirty participants actually started taking sirolimus, 16 completed the full 20-week treatment course, and 28 completed the overall study. The reported data shows that 3 out of 32 participants met what the researchers called the "composite safety endpoint" — meaning they either experienced a serious adverse event considered possibly, probably, or definitely related to the drug, or had a meaningful drop in their CD4+ cell count while on sirolimus. For the HIV-related measurements, the reported data shows that a specific marker of immune activity (the proportion of certain immune cells responding to HIV, measured as a percentage) was 0.11% both at baseline and after treatment, with a reported change of −0.01 percentage points — essentially no notable numerical change. Separately, a measure of HIV material found inside CD4+ cells was reported as 2.56 at baseline and 2.35 at a later timepoint, reflecting a change of −0.21 in the units used (a logarithmic scale, meaning each whole-number change represents a tenfold difference). For plasma HIV levels measured by a highly sensitive test, the reported data shows the number of participants with a detectable result ranged between 7 and 9 across the various timepoints measured; further detail on those individual timepoints was not broken down in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03982433 · results posted 13 December 2019

  According to the results reported on ClinicalTrials.gov, this trial (NCT03982433) enrolled 8 participants in a single intervention group, with 7 completing the study and 1 not completing it. The trial was measuring pain levels, alcohol use, and how satisfied participants were with the treatment they received. Because there was only one group in the study, there was no comparison group — the reported numbers simply reflect where participants stood at the end of the trial. The reported data shows that, on average, participants scored 5.0 out of 10 on the pain severity scale (where 0 means no pain and 10 means the worst possible pain), and 2.43 out of 10 on the pain interference scale (where higher numbers mean pain is getting in the way of daily life more). For alcohol use, the reported data shows an average of 2 heavy drinking episodes in the past 30 days, and an average of 13 drinks per week over that same period. It is important to note that the data as submitted does not include figures from before the trial started, so there are no "before and after" numbers to compare these results against. The reported data also shows how participants felt about the treatment itself. On a satisfaction questionnaire scored from 8 to 32 (with higher meaning more satisfied), participants averaged 29.29 out of 32. On a separate perceptions-of-treatment questionnaire scored from 0 to 8, participants averaged 7.04 out of 8. These figures reflect how the participants rated their experience with the intervention, not whether it worked in any medical sense. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT02888756 · results posted 9 December 2019

  According to the results reported on ClinicalTrials.gov, this trial (NCT02888756) enrolled 33 people living with HIV across three groups: 16 received the experimental vaccine called iHIVARNA-01, 9 received a comparator called TriMix, and 8 received a placebo. The trial was measuring two main things: whether the vaccines caused any serious side effects, and whether they prompted the immune system to respond more strongly against HIV (measured using a laboratory test called ELISPOT, which counts immune cells reacting to the virus). All participants completed the vaccination phase, though fewer went on to complete the second phase — a planned pause in their HIV medication known as an "analytical treatment interruption" — with 5, 3, and 3 participants finishing that phase in each group respectively. The reported data shows that, for the primary safety outcome, zero participants in any of the three groups experienced a serious treatment-related side effect (Grade 3 or above, meaning significant or severe) that was linked to the vaccinations. For the immune response outcome, the reported changes from baseline in ELISPOT scores were small and varied across the groups and time points; at the first measurement the iHIVARNA-01 group showed −0.07, the TriMix group 0.18, and the placebo group 0.01, and at the second measurement the figures were −0.08, −0.12, and 0.45 respectively (these numbers represent the change in a laboratory unit used to count immune cell activity). For the secondary outcomes, the reported data shows that the median number of days until the virus rebounded after stopping medication was 50 days for iHIVARNA-01, 55.5 days for TriMix, and 58 days for placebo. No participant in any group had an undetectable viral load (below 50 copies per millilitre of blood) at the final measurement point. Data for one secondary measure — a specific type of immune cell analysis called intracellular cytokine staining — was not reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02012621 · results posted 25 November 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 807 people living with HIV who were taking a medication called tenofovir as part of their treatment. The study was looking at two things: whether a blood test measuring the actual level of the drug in the body (using dried blood spots, a simple finger-prick sample stored on card) lined up with having a very low, undetectable amount of HIV in the blood; and whether people's own reports of how regularly they took their medication also lined up with that same outcome. Participants attended up to three clinic visits, with 688 completing a second visit and 444 completing a third. The reported data shows the results as "adjusted odds ratios" — a way of expressing how much more likely one outcome is compared to another, after accounting for other differences between people. For the drug level measurement, people whose dried blood spot showed a high drug concentration (at or above 1,850 femtomoles per punch, a very small unit of measurement) were reported to have an adjusted odds ratio of 73.5 compared to those with a low drug concentration (below 350 femtomoles per punch) for having an undetectable HIV level at all study visits. The reported data also shows that people who said they took 100% of their doses over three months had an adjusted odds ratio of 8.5 compared to those reporting less than 28.5% of doses taken. A separate analysis looking ahead to the *next* visit reported an adjusted odds ratio of 4.7 when comparing higher versus lower drug concentrations. These reported numbers describe associations observed in this particular group of study participants — they do not on their own prove that one thing directly caused another. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT01896921 · results posted 19 November 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 7 people who were taking a combination of two HIV medications — maraviroc plus either raltegravir or dolutegravir. The trial was measuring how well this drug combination kept the amount of HIV in participants' blood at a very low level (fewer than 50 copies of the virus per millilitre of blood, which is considered undetectable). Of the 7 people who started, 5 completed the trial and 2 did not finish. The reported data shows that at 48 weeks, 5 out of the 7 participants had HIV levels below that very low threshold of 50 copies per millilitre. A separate secondary measurement — taken at an earlier or different time point, though the exact timing was not specified in the data — reported that 4 participants had reached that same low HIV level. The reported data also shows that 3 out of 7 participants experienced adverse events, meaning unwanted or unexpected health issues that were recorded during the trial. No further detail about the nature of those events was included in the data provided. It is worth noting that this was a very small trial with only 7 participants, and the results should be understood in that context. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT02103218 · results posted 18 October 2019

  According to the results reported on ClinicalTrials.gov, this trial involved 212 participants across four groups: daughters in a "Risky Sex Prevention" programme (51 started, 46 completed), daughters in a "Healthy Behaviors" programme (59 started, 51 completed), mothers in the "Risky Sex Prevention" group (48 started, 44 completed), and mothers in the "Healthy Behaviors" group (54 started, 47 completed). The trial was measuring several things related to sexual behaviour in adolescent girls, including a general sexual activity score, the likelihood of having sex without a condom, having sex with more than one partner, and using drugs or alcohol during sex. It also measured the girls' knowledge about HIV and the strength of the mother-daughter relationship. The reported data shows the following numbers across the two daughter groups at follow-up. On the sexual activity scale (where 0 means no activity and 10 means the most activity), the Risky Sex Prevention group scored 2.12 and the Healthy Behaviors group scored 1.90. For the predicted likelihood of having sex without a condom in the past three months, the figures were 8.4% for the Risky Sex Prevention group and 2.4% for the Healthy Behaviors group. The predicted likelihood of ever having had sex with more than one partner was reported as 1.0% and 2.2% respectively. For drug or alcohol use during sex in the past three months, the figures were 1.3% and 5.1%. These are predicted probabilities based on a statistical modelling method, not simple counts of how many participants reported each behaviour. The reported data also shows results for the two secondary measures. On the HIV knowledge questionnaire (scored 0–18, where higher means more knowledge), the Risky Sex Prevention group scored 13.1 and the Healthy Behaviors group scored 10.4 at follow-up. On the mother-daughter bond scale (scored 8–40, where higher means a stronger bond), the scores were 26.8 and 28.9 respectively. Earlier time-point measurements were also reported for most outcomes, and these were generally similar in pattern, though the data does not include information on what any of these differences between groups mean statistically. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT01298596 · results posted 18 October 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 400 women with HIV who had been diagnosed with cervical intraepithelial neoplasia (CIN) — a term for abnormal cell changes on the cervix. Two hundred women were assigned to receive cryotherapy (a freezing treatment applied to the cervix) and 200 were assigned to receive a procedure called Loop Electrosurgical Excision Procedure, or LEEP (where abnormal tissue is removed using a small wire loop and electrical current). The trial followed participants for up to two years and was measuring whether those abnormal cell changes came back, as well as whether either procedure affected the amount of HIV detectable on the cervix in the weeks immediately after treatment. By the end of the study, 172 women in the cryotherapy group and 167 in the LEEP group had completed the trial. The reported data shows that over the two-year follow-up period, 60 participants in the cryotherapy group and 37 participants in the LEEP group had a recorded recurrence of abnormal cervical cell changes. For the secondary outcome, the trial measured changes in the amount of HIV detectable on the cervix (recorded as a technical unit called "log10 copies per swab") at one, two, and three weeks after treatment, compared to before treatment. The reported data shows that in the cryotherapy group, the change from baseline was −0.02 at week one, +0.07 at week two, and +0.05 at week three. In the LEEP group, the reported changes were +0.10 at week one, +0.25 at week two, and +0.26 at week three. These figures represent small shifts in the measured level of HIV on the cervix at those time points. It is important to note that these numbers alone do not tell the whole story — factors such as how many participants were included in each measurement and other aspects of the study design would be needed for a fuller picture, and that additional detail was not included in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT01504841 · results posted 17 September 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled young children who had previously been treated for HIV-1 (the virus that causes AIDS). Participants were divided into age groups: 20 children aged 2 to 6 years (Cohort I) and 6 children aged 1 to 2 years (Cohort II). A third group for children aged 2 months to 1 year (Cohort III) was planned but no children were enrolled. The trial was measuring things like how the body processed the study drug (etravirine, or ETR), how many children stopped treatment due to a suspected drug reaction, how many experienced serious side effects, and how many children's virus levels did not come down enough during treatment. The reported data shows the following numbers across the two enrolled age groups. Regarding stopping treatment due to a suspected drug reaction, 1 child in Cohort I and 0 children in Cohort II did so. For serious side effects (graded 3 or higher in severity, meaning more significant reactions), 4 children in each cohort experienced these. No deaths were recorded during the study. The drug level in the blood over 12 hours (a measure of how much medicine was circulating in the body) was reported as 5,512.85 ng\*h/mL for Cohort I and 4,821.76 ng\*h/mL for Cohort II. On the question of whether the virus was sufficiently suppressed at weeks 24 and 48, the reported data shows that across both time points and both cohorts, small numbers of children — ranging from 1 to 3 per cohort at each check-in — were recorded as not meeting the suppression target, though the data as submitted makes it difficult to match every individual figure precisely to each time point and cohort. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT02339415 · results posted 6 September 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 44 participants in total (22 in each group) and used a "crossover" design — meaning everyone took both the active drug (edoxaban, a blood-thinning medication) and a placebo (a dummy treatment with no active ingredient) at different times, with a washout break in between. The trial was measuring whether edoxaban changed levels of certain proteins in the blood — specifically interleukin-6 (IL-6), a marker linked to inflammation, and D-dimer, a marker linked to clotting activity. By the end of the study, 37 of the 44 participants had completed both periods. The reported data shows that for the primary measure — the change in IL-6 levels after four months — the placebo group showed a change of −0.02 (on a natural log scale used to handle the wide spread of values) while the edoxaban group showed a change of +0.09 on the same scale. For the secondary measure, D-dimer levels, the placebo group showed a change of −0.13 and the edoxaban group showed a change of −0.66 on the same type of log scale, meaning D-dimer appeared to fall more in the edoxaban period than the placebo period. These are the numbers as submitted; what they mean clinically was not described in the structured results data. The reported data also includes counts of bleeding events recorded during the trial. Across several categories of bleeding, the numbers reported while participants were receiving edoxaban were generally higher than when they were receiving placebo (for example, one category recorded 10 events on edoxaban versus 3 on placebo; another recorded 8 versus 2). The full breakdown of what each bleeding category represents was not detailed in the structured data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT00390949 · results posted 29 August 2019

  According to the results reported on ClinicalTrials.gov, this trial involved two groups of participants from communities — a Control Arm (4,662 people at the start) and an Intervention Arm (4,792 people at the start). By the end of the study, around 2,564 and 2,664 people respectively had completed it. The trial was measuring the rate of new HIV infections across communities, as well as a range of other things including self-reported genital sores or discharge, whether people said their sexually transmitted infection (STI) symptoms went away after treatment, how many people reported having more than one casual sexual partner, and how many people had attended a peer education programme. The reported data shows that for the main measure — new HIV infections per 100 person-years (meaning the number of new infections counted across every 100 people followed over one year) — the Control Arm recorded 1.49 and the Intervention Arm recorded 2.04. For the secondary measures, the reported data shows that self-reported genital ulcers were noted in 9.04% of the Control Arm and 7.47% of the Intervention Arm. Self-reported genital or urethral discharge was recorded in 11.91% of the Control Arm and 10.50% of the Intervention Arm. The percentage of people who said their STI symptoms went away after treatment was 71.58% in the Control Arm and 60.44% in the Intervention Arm. Reporting more than one casual partner in the past three years was recorded at 14.59% (Control) and 13.38% (Intervention). Attendance at a peer education or programme meeting was reported by 20.25% of the Intervention Arm and 4.75% of the Control Arm. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT02898597 · results posted 5 August 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 49 people who smoked and were trying to quit. Participants were split into two groups: 25 people received video-based support and 24 received telephone-based support. The trial was measuring how many people reported staying smoke-free since their nominated quit day, with that self-report checked using a saliva test at three months and six months after quitting. The reported data shows that, of those who started the trial, 21 out of 25 people in the video group completed the study, while only 12 out of 24 people in the telephone group completed it — meaning 12 people in the telephone group did not finish. When it came to the primary outcome — the number of participants who reported abstaining from smoking — the reported figures were 8 out of 25 in the video group and 1 out of 24 in the telephone group. No additional outcome measures were included in the data submitted to ClinicalTrials.gov, so no further figures can be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT02951052 · results posted 13 June 2019

  According to the results reported on ClinicalTrials.gov, this trial (NCT02951052) involved 616 people living with HIV-1 who were already on HIV treatment. They were split into two groups of 308 each: one group switched to a new long-acting injectable combination (cabotegravir and rilpivirine, given by injection every four weeks), while the other group stayed on their current daily HIV medication. The trial ran for 48 weeks and was primarily measuring how many people in each group had a detectable level of virus in their blood — specifically, whether the level rose to 50 or more copies per millilitre of blood — as a way of comparing the two approaches. The reported data shows that at the 48-week mark, 5 out of 308 participants in the injectable group had virus levels at or above 50 copies per millilitre, compared with 3 out of 308 in the group who stayed on their existing treatment. Looking at the flip side — those with virus levels below 50 copies per millilitre, which is the goal of HIV treatment — 285 people in the injectable group and 294 in the current-treatment group reached that level. When a slightly higher threshold of below 200 copies per millilitre was used, those numbers were 286 and 295 respectively. The trial also tracked "confirmed virologic failure" (two consecutive blood test results showing virus levels of 200 copies or more after previously being suppressed); by the end of the study, cumulative counts in this category were 3 in the injectable group and 4 in the current-treatment group, though the reported data shows these numbers built up gradually over the course of the trial. Average virus levels in the blood, measured on a scientific scale, were 1.505 (injectable group) and 1.518 (current treatment group) at week 48. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT03045861 · results posted 29 May 2019

  According to the results reported on ClinicalTrials.gov, this trial (NCT03045861) tested four different doses of an investigational drug called GSK2838232 — 20 mg, 50 mg, 100 mg, and 200 mg — in people living with HIV-1. The trial ran in two parts, each lasting up to 10 days. In Part A, 10 participants received the 100 mg dose. In Part B, 7 participants received the 20 mg dose, 8 received the 50 mg dose, and 8 received the 200 mg dose. The trial was measuring how much the level of HIV in participants' blood (called HIV-1 RNA, essentially a count of virus copies) changed after taking the drug, as well as tracking any adverse events (unwanted medical occurrences) and changes in blood and urine test results. The reported data shows that the main measurement — the largest drop in HIV-1 virus copies in the blood from the starting point — varied across the dose groups. The 20 mg group showed a reported maximum decline of approximately 42,095 copies per millilitre; the 50 mg group showed approximately 49,066 copies per millilitre; the 100 mg group showed approximately 32,948 copies per millilitre; and the 200 mg group showed approximately 33,149 copies per millilitre. Regarding adverse events, the reported data shows that 3 participants in the 20 mg group, 3 in the 50 mg group, 5 in the 100 mg group, and 5 in the 200 mg group experienced at least one adverse event. No serious adverse events were reported in any group. The reported data also shows no participants had abnormal liver function results of potential clinical concern, and no participants had abnormal urine test results. A small number of participants across some groups had certain blood chemistry or blood count readings outside the ranges considered clinically important, with the specific numbers varying by dose group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT01295515 · results posted 23 April 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 7 people, all of whom completed the study — none dropped out. All participants received interferon treatment. The trial was measuring levels of HIV genetic material (both RNA and DNA) inside cells and in the bloodstream, before and after the interferon treatment was given. RNA and DNA are the genetic building blocks that the HIV virus uses to copy itself inside the body. The reported data shows that, for the primary outcomes, HIV RNA levels inside cells (measured in copies per million cells) across individual participants ranged from readings of 90 to 850 before treatment and 12 to 390 after treatment, though no overall summary average was reported for the group as a whole — only the individual values were listed. Similarly, HIV DNA levels inside cells ranged from 150 to 1,200 before treatment and 10 to 520 after treatment, again as individual participant figures rather than a single group average. For the secondary outcomes, plasma HIV RNA (the amount of virus in the bloodstream) was reported at very low levels across time points, ranging from 0.02 to 9.1 copies per millilitre. The fold change in the ratio of HIV RNA to DNA — a way of expressing how much one measurement shifted relative to another — ranged from 0.408 to 4.37 across the 7 participants. The reported data also shows that all 7 participants had at least one adverse event (an unwanted or unexpected experience during the trial) recorded and assessed for severity and its relationship to the study treatment, though a breakdown of those events was not included in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT02475655 · results posted 18 April 2019

  According to the results reported on ClinicalTrials.gov, this trial (NCT02475655) enrolled 60 people living with HIV who were on antiretroviral therapy (ART). Forty participants were assigned to take ruxolitinib (a medicine that affects the immune system) alongside their usual HIV treatment, while 20 participants received no study treatment and acted as a comparison group. The trial was primarily looking at whether certain pre-defined "safety milestone" events occurred — these were a list of specific concerning changes, such as a significant drop in immune cells (CD4+ cells), the HIV virus becoming detectable again in the blood, serious infections, or serious side effects. The trial also measured changes in a marker of inflammation in the blood called interleukin-6 (IL-6). The reported data shows that during the treatment period, 2.5% of participants in the ruxolitinib group (roughly 1 out of 40 people) experienced any of the pre-defined safety milestone events, compared with 0% in the no-treatment group over the same early period. When each individual type of safety milestone event was looked at separately for the first five weeks, the reported data shows 0% for both groups across all individual categories listed. Three participants in the ruxolitinib group stopped taking the study treatment early. For the inflammation marker IL-6, the reported data shows that levels in the ruxolitinib group changed by a factor of 0.93 from the starting point to weeks 4–5 (meaning very little change, slightly below the starting level), while in the no-treatment group the factor was 1.10 (slightly above the starting level). Over the entire follow-up period — including after the treatment phase ended — 7.5% of participants in the ruxolitinib group experienced at least one safety milestone event. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT02831673 · results posted 18 April 2019

  According to the results reported on ClinicalTrials.gov, this trial (NCT02831673) enrolled 719 adults living with HIV-1 (359 in one group, 360 in the other) across a double-blind phase running to Week 96, followed by an open-label phase to Week 148, and then a continuation phase to Week 280. The trial compared two HIV treatment combinations: dolutegravir plus lamivudine (DTG + 3TC) against dolutegravir plus a two-drug tablet of tenofovir and emtricitabine (DTG + TDF/FTC). The main thing being measured was the proportion of participants whose blood HIV levels dropped below 50 copies per millilitre — a level considered undetectable using the study's measurement method — at 48 weeks. The reported data shows that at the 48-week mark (the primary measure), 90% of participants in the DTG + 3TC group and 93% in the DTG + TDF/FTC group had HIV levels below 50 copies per millilitre. At the earlier 24-week check, the reported figures were 92% and 93% respectively. By Week 96, those figures were 84% and 89%, and by Week 144 they were 79% and 83%. The reported data also shows that in both groups, the midpoint time for HIV levels to first drop below 50 copies per millilitre was 29 days. Separately, a measure of immune cell counts (CD4+ cells, which can reflect immune health) was also tracked — at Week 48, the average count was reported as approximately 688 cells/mm³ in the DTG + 3TC group and 675 cells/mm³ in the DTG + TDF/FTC group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT00461552 · results posted 5 March 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 14 people in total, split evenly into two groups of 7 — one group received leptin (a naturally occurring hormone) and the other received a placebo (an inactive treatment). The trial was measuring fasting triglycerides (a type of fat found in the blood, measured after not eating overnight) as its main outcome, and body weight as a secondary outcome. All 7 people in the leptin group completed the study, while 5 out of 7 completed it in the placebo group, with 2 not finishing. The reported data shows that, at the time outcomes were measured, the leptin group had an average fasting blood triglyceride level of 237 mg/dL, compared to 341 mg/dL in the placebo group. For body weight, the reported data shows an average of 68.6 kg in the leptin group and 73.3 kg in the placebo group. The data as submitted does not include information about how these numbers changed from the start of the trial, so it is not possible to say from this data alone how much each group's levels shifted over the course of the study. It is worth noting that this was a very small trial with only 14 participants across both groups, and the results reflect only what was observed in this specific group of people under the conditions of this study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT03078556 · results posted 21 February 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 154 healthy adult participants across two parts (approximately 77–78 per part). It was a pharmacokinetic study — meaning it tracked how two HIV medicines, dolutegravir (DTG) and lamivudine (3TC), moved through the body after being swallowed. The trial compared taking the two drugs as separate tablets versus taking them together in a single combined tablet (called a fixed-dose combination, or FDC). Two different combined tablet designs were tested: a "monolayer" version (Part 1) and a "bilayer" version (Part 2). Each participant received different treatments in sequence, with rest periods in between. The reported data shows the key measurements were: how much of each drug was absorbed into the bloodstream in total (measured as an area under a concentration curve, essentially a running total of drug levels over time), and the highest drug level reached in the blood (the peak concentration). For Part 1, the reported total drug exposure figures for DTG were 43.1 (separate tablets) versus 54.9 (monolayer combined tablet) in the units used, and for 3TC were 12.3 versus 12.8. Peak blood levels for DTG were 2.41 versus 3.08, and for 3TC were 2.67 versus 3.19. For Part 2, the reported total exposure figures for DTG were 47.2 (separate tablets) versus 54.6 (bilayer combined tablet), and for 3TC were 12.8 versus 13.6. Peak blood levels for DTG were 2.55 versus 2.91, and for 3TC were 2.44 versus 3.22. All measurements were taken in the fasted (not having eaten) state. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT00978068 · results posted 28 December 2018

  According to the results reported on ClinicalTrials.gov, this trial enrolled 176 HIV-positive adults (87 in one group and 89 in the other) who were living in an area where malaria is common. The trial was comparing two different types of HIV treatment combinations to see how often participants developed malaria while taking them. One group took a drug combination called LPV/r plus two other HIV medicines, and the other group took either nevirapine or efavirenz plus two other HIV medicines. Most participants finished the study — 83 in the first group and 80 in the second. The reported data shows that for the main thing being measured — how often malaria occurred relative to the time participants were monitored — the LPV/r group had a rate of 1.32 malaria episodes per person-year, compared with 2.25 episodes per person-year in the nevirapine/efavirenz group. For serious (complicated) malaria specifically, the rates were very similar: 0.024 versus 0.026 episodes per person-year. Looking at the chance of getting a first malaria episode within six months, the reported figures were 40.7% in the LPV/r group and 52.5% in the other group. For participants who were treated for malaria with a specific antimalarial medicine (artemether-lumefantrine), the reported data shows that within 28 days of that treatment, malaria parasites were detected again in 14.0% of the LPV/r group compared with 40.8% of the other group; and within 63 days, recurrent malaria was reported in 28.1% versus 54.2% respectively. Regarding unwanted side effects in the 28 days after antimalarial treatment, 71.0% of malaria episodes in the LPV/r group and 79.3% in the other group were accompanied by a recorded adverse event of moderate severity or higher that was considered possibly related to study drugs. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT02120716 · results posted 12 December 2018

  According to the results reported on ClinicalTrials.gov, this trial involved 50 pregnant women across two groups. Thirty-one participants were placed in the "Health Check-Up of Expectant Moms" (HCEM) group, which received a computer-based programme, while 19 participants were placed in a comparison group that received a different form of attention and support. The trial was primarily measuring whether the computer programme and its software were acceptable and easy to use for participants, and secondarily looking at self-reported sexual risk behaviour and alcohol or drug use before and after the programme. The reported data shows that, among those in the HCEM group, satisfaction with the computer software scored an average of 4.8 out of 5, and satisfaction with the specific components of the HCEM programme (such as videos and information resources) scored an average of 6.6 out of 7. Regarding sexual risk behaviour (specifically, sex without a condom), the reported data shows that 27% of participants in the HCEM group reported a reduction in this behaviour by follow-up, compared with 5% in the comparison group. For alcohol or drug use, the reported data shows that 77% of the HCEM group and 58% of the comparison group reported using alcohol or drugs at the start of the study; by the 4-month follow-up, those figures were reported as 23% and 42% respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02263326 · results posted 13 November 2018

  According to the results reported on ClinicalTrials.gov, this trial enrolled 89 people living with HIV who were already on an HIV treatment regimen (known as ART). Participants were split into two groups: 44 people switched to a two-drug combination called dolutegravir plus lamivudine, while 45 people stayed on their existing HIV treatment. The trial ran for 48 weeks and was primarily measuring "treatment failure" — defined as the virus becoming detectable again in the blood (above 50 copies per millilitre), losing contact with the study, or stopping the assigned treatment. The reported data shows that treatment failure occurred in approximately 6.8% of people in the dolutegravir plus lamivudine group (roughly 3 out of 44) and approximately 6.7% of people in the group who stayed on their current treatment (roughly 3 out of 45). For the secondary outcomes, the reported data shows that around 90.9% of the switch group and 88.9% of the stay-on-current-treatment group had undetectable virus levels at 48 weeks. Regarding immune cell counts (CD4 cells, which reflect immune health), the switch group showed an average rise of 39 cells/mm³ from the start of the study, compared to 28 cells/mm³ in the other group. Changes in cholesterol and kidney function (measured by creatinine clearance) were also tracked — the reported figures showed small changes in both directions across both groups, with no large differences noted between them. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01484340 · results posted 6 November 2018

  According to the results reported on ClinicalTrials.gov, this trial enrolled 560 people who smoked — 281 in a group that received counselling only, and 279 in a group that received nicotine replacement therapy (NRT) plus counselling. All participants completed the study. The trial was measuring smoking status using two types of breath and urine tests: one that detects carbon monoxide (CO) in exhaled breath (measured in parts per million, or ppm), and one that detects cotinine (a substance the body produces after absorbing nicotine) in urine. A CO reading of 7 ppm or below, or a cotinine reading below 0.4 micrograms per millilitre, was used to indicate that a person had stopped smoking. The reported data shows that, on the primary outcome measures, both groups had an average exhaled CO reading of 11 ppm — the same result for both the counselling-only group and the NRT-plus-counselling group. For the urine cotinine test, the counselling-only group recorded an average of 1.7 micrograms per millilitre, and the NRT-plus-counselling group recorded an average of 1.5 micrograms per millilitre. Both of these average figures are above the thresholds the trial used to define abstinence from smoking. The reported data also shows two sets of secondary outcome measurements using the CO breath test. In one set, the counselling-only group averaged 9 ppm and the NRT-plus-counselling group averaged 11 ppm. In the other set, both groups averaged 10 ppm. No further detail about when these secondary measurements were taken was provided in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02897141 · results posted 10 October 2018

  According to the results reported on ClinicalTrials.gov, this trial involved 80 adults living with HIV, split evenly into two groups of 40. One group used an app-based programme called mVIP, while the other group received an attention control (a comparison condition designed to account for the effect of simply receiving some form of support). The trial ran for 12 weeks and measured several things, including how much physical symptoms bothered participants, quality of life, engagement with healthcare providers, medication-taking behaviour, and how easy the technology was to use. Of the 80 people who started, 77 completed the trial — 38 in the mVIP group and 39 in the control group. The reported data shows that for the main outcome — how much 13 common HIV-related symptoms bothered participants — both groups reported lower bother scores after 12 weeks compared to the start. The difference-between-groups score (a way of comparing how much each group changed relative to the other) was reported as ranging from around -0.007 to -0.541 across four individual symptoms measured, where a more negative number means the intervention group reported less bother compared to the control group. For the secondary outcomes, quality-of-life scores (measured by two different tools — the RAND-36 and the PROMIS-29) were reported at similar levels in both groups at follow-up, with no large numerical gaps between the mVIP and control groups. Scores for engagement with healthcare providers, medication adherence, and technology usability were also reported as broadly similar between the two groups — for example, medication adherence scores on one scale were 12.97 (mVIP) versus 12.69 (control), and on a percentage-based scale were 85.97% versus 87.03%. It is worth noting that the reported data does not include all the context needed to interpret what these numbers mean in a clinical sense, and some details — such as which specific symptoms corresponded to which difference scores — were not fully labelled in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT02362503 · results posted 18 September 2018

  According to the results reported on ClinicalTrials.gov, this trial enrolled 371 adults with HIV-1 who had few or no remaining treatment options. The trial was split into two parts: a short blinded phase of up to 8 days, where 69 participants received a placebo and 203 received fostemsavir (600 mg twice daily), and a longer open-label phase of up to 96 weeks where all participants — including an additional 99 who joined separately — received fostemsavir alongside their other HIV medications. The trial was measuring how much the level of HIV-1 virus in the blood (called "viral load") changed over time. The reported data shows that during the short 8-day blinded phase, the average change in viral load (measured on a scientific scale called log10, where a reduction of 1.0 means the virus level dropped tenfold) was −0.17 for the placebo group and −0.79 for the fostemsavir group. For a secondary measure looking at how many participants achieved a meaningful drop in viral load by Day 8, the reported data shows that about 65% of the fostemsavir group had a drop greater than 0.5 on that scale, compared with about 19% in the placebo group; and about 46% of the fostemsavir group had a drop greater than 1.0, compared with about 10% in the placebo group. During the longer open-label phase, when all randomised participants were receiving fostemsavir, the reported data shows that 53% had viral load below 40 copies per millilitre at Week 24, 54% at Week 48, and 60% at Week 96. Regarding safety tracking, the reported data shows that 92 participants in the randomised group experienced a serious adverse event (an unexpected medical problem considered serious) during treatment, and 14 stopped the study due to an adverse event. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT02431247 · results posted 14 September 2018

  According to the results reported on ClinicalTrials.gov, this trial enrolled 725 adults living with HIV — 362 in the group taking a single combined tablet called D/C/F/TAF, and 363 in a comparison group taking two separate medicines (DRV/COBI plus FTC/TDF). After the first phase of the trial, participants in the comparison group were switched to D/C/F/TAF for a further period. The trial was primarily measuring how many people in each group had the amount of HIV in their blood (called viral load) fall below a very low level — fewer than 50 copies per millilitre — at 48 weeks. It also tracked a range of other measurements over time, including immune cell counts and kidney-related markers. The reported data shows that at 48 weeks, 91.4% of people in the D/C/F/TAF group and 88.4% of people in the comparison group had HIV levels below 50 copies per millilitre, as measured by the primary method used. For secondary measures at 48 weeks, immune cells known as CD4+ cells (a marker of immune health) increased from the start of the trial by an average of about 190 cells/mm³ in the D/C/F/TAF group and about 172 cells/mm³ in the comparison group. A kidney marker called serum creatinine rose by an average of 0.05 mg/dL in the D/C/F/TAF group and 0.09 mg/dL in the comparison group. After participants from the comparison group switched to D/C/F/TAF, some viral load measurements were also reported for that switch group, with figures ranging up to 96.9% below certain thresholds at later time points, though the full breakdown across all sub-measures is detailed in the trial record. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT00084149 · results posted 13 September 2018

  According to the results reported on ClinicalTrials.gov, this trial enrolled 54 people in total — 36 in a group that received cyclosporine (a medication that affects the immune system) alongside their usual HIV treatment, and 18 in a group that did not receive cyclosporine. Of those who started, 28 in the cyclosporine group and 13 in the no-cyclosporine group completed the study. The trial was measuring levels of HIV genetic material (called proviral DNA) in blood cells — essentially looking at how much of the virus's genetic blueprint was detectable in participants' white blood cells. The reported data shows that the primary measurement — proviral DNA in blood cells — came out at 1.88 log10 copies/mL in the cyclosporine group and 1.92 log10 copies/mL in the no-cyclosporine group. (The "log10" scale is a way of expressing very large or small numbers more simply — a difference of 0.04 on this scale represents a relatively small numerical difference.) The reported data also shows several secondary measurements: at two additional time points, proviral DNA readings were 2.12 vs 1.96 and 2.22 vs 2.13 for the cyclosporine and no-cyclosporine groups respectively. HIV viral load (the amount of active virus in the blood) was reported as 1.70 log10 copies/mL in both groups. The number of participants with a viral load below 50 copies/mL — a common benchmark in HIV monitoring — was reported as 27 out of 36 in the cyclosporine group and 13 out of 18 in the no-cyclosporine group. Regarding side effects linked to the study medication, 1 participant in the cyclosporine group and 0 in the no-cyclosporine group were reported to have had a related adverse event. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT02573948 · results posted 8 August 2018

  According to the results reported on ClinicalTrials.gov, this trial involved people who inject drugs in two stages. First, a larger group of 603 people took part in a survey-style recruitment phase. From that group, 250 people were enrolled into a follow-up study where they were checked in on over roughly one year (52 weeks). The trial was measuring how many people stayed in the study, and tracking whether participants who did not already have hepatitis C (HCV) or HIV went on to acquire either infection during that year. The reported data shows that 194 of the 250 people who joined the follow-up study were still participating at the final check-in at week 52 — 56 people did not complete this phase. Among those who did not have hepatitis C at the start, 18 people recorded a new HCV infection over the course of the year. The reported rate of new HCV infections was 19.4 per 100 person-years (meaning that for every 100 people followed for a full year, roughly 19.4 new infections were recorded). For HIV, the reported data shows zero new infections among those who did not have HIV at the start, giving a reported rate of 0 per 100 person-years. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT02607956 · results posted 6 June 2018

  According to the results reported on ClinicalTrials.gov, this trial (NCT02607956) enrolled 657 people living with HIV-1 — 327 received a single combination tablet called B/F/TAF, and 330 received a two-drug regimen called DTG + F/TAF. The trial was measuring the proportion of participants whose level of HIV in the blood (known as "viral load") fell below certain very low thresholds at set points in time — specifically at 48 weeks, 96 weeks, and 144 weeks. The trial ran in two phases: a blinded phase where participants did not know which treatment they were on, followed by an open-label extension where all participants took B/F/TAF and knew what they were receiving. The reported data shows that at the 48-week mark (the main measurement point), 89.4% of participants in the B/F/TAF group and 92.9% in the DTG + F/TAF group had viral loads below 50 copies per millilitre of blood — a level considered very low. Using an even stricter threshold of below 20 copies per millilitre, the reported figures were 82.2% and 87.1% respectively. At 96 weeks, the reported data shows those proportions were 84.1% (B/F/TAF) and 86.5% (DTG + F/TAF) at the less-than-50 threshold, and 77.5% and 80.3% at the less-than-20 threshold. By 144 weeks, the reported figures were 81.9% and 84.0% at the less-than-50 threshold, and 77.5% and 79.1% at the less-than-20 threshold. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT01561755 · results posted 13 April 2018

  According to the results reported on ClinicalTrials.gov, this trial enrolled 12 people in total — 6 received intravenous immunoglobulin (a treatment made from donated blood proteins, given through a drip) and 6 received a placebo (an inactive substitute). All 6 in the treatment group completed the trial, while 5 of the 6 in the placebo group completed it (one did not finish, though the reason was not reported here). The trial was measuring lower-limb muscle strength as its main focus, along with several secondary measures including walking ability, bladder and bowel function, overall physical functioning, and participants' own sense of how they had changed. The reported data shows that for the primary measure — lower-limb strength recorded in pounds of force — multiple readings were reported across both groups. The treatment group's figures included readings of 14.0, 12.4, 1.7, and 28.2 pounds of force, while the placebo group's corresponding figures were 1.9, 10.3, −6.0 (a negative number, indicating a recorded decrease), and 6.2 pounds of force. For the secondary measures, the reported data shows the two-minute walking test averaged 93.49 metres in the treatment group and 112.08 metres in the placebo group. On the bladder function scale (0 = normal, 5 = most severe), both groups scored similarly at around 2.6 and 2.5 respectively. On the bowel function scale (same 0–5 range), the treatment group averaged 1.3 and the placebo group averaged 2.07. On the Hughes Function Score (a 0–5 scale of physical ability), both groups averaged approximately 3, meaning participants generally needed a walker or cane. Participants' own impression of change (on a 1–7 scale where 1 = marked improvement and 7 = marked worsening) averaged 3.58 in the treatment group and 3.7 in the placebo group, both sitting close to the "minimal improvement" to "no change" range. It is worth noting that with only 12 participants in total, this was a very small trial, and the data as submitted does not include sufficient context to explain all individual measurement points listed under the strength outcome. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT00458393 · results posted 24 January 2018

  According to the results reported on ClinicalTrials.gov, this trial (NCT00458393) enrolled 2,499 people in total — 1,251 in the group receiving a combination pill called TDF/FTC and 1,248 in the group receiving a placebo (a dummy pill with no active ingredient). The trial was measuring whether TDF/FTC could reduce the number of new HIV infections, and it also tracked certain changes in blood markers related to kidney function and phosphorus levels, as well as broader side-effect events. Around 942–953 participants in each group completed the study. The reported data shows that when it came to confirmed new HIV infections, 48 people in the TDF/FTC group acquired HIV compared with 83 people in the placebo group. For kidney-related changes (a measure called creatinine reaching at least a mild threshold), 32 people in the TDF/FTC group and 24 in the placebo group recorded this change. For a more serious phosphorus-related change in the blood, 13 people in the TDF/FTC group and 10 in the placebo group were recorded. The reported data also shows that moderate-to-severe-or-worse laboratory abnormalities were recorded in 70 people (TDF/FTC) and 79 people (placebo), while moderate-to-severe-or-worse clinical side-effect events were recorded in 157 people (TDF/FTC) and 162 people (placebo). For the secondary outcome looking at liver flares among participants who already had Hepatitis B, the reported data shows zero participants in either group experienced this event. It is worth noting that these numbers describe what was counted and recorded in the trial — they do not on their own tell us what caused any individual outcome. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT01949116 · results posted 10 January 2018

  According to the results reported on ClinicalTrials.gov, this trial (NCT01949116) enrolled 176 people living with HIV — 86 in the low-dose methotrexate (LDMTX) group and 90 in the placebo group — and followed them for 36 weeks. The trial was measuring two main things: whether the treatment was associated with any pre-defined safety concerns, and whether it changed a measure of blood vessel function called flow-mediated vasodilation (FMD) — a test that looks at how much a large arm artery widens in response to increased blood flow, expressed as a percentage. Most participants completed the study (78 in the LDMTX group and 84 in the placebo group). The reported data shows that, for the main safety outcome, 11 out of 86 participants in the LDMTX group reached at least one of the pre-defined safety milestones over 36 weeks, compared with 5 out of 90 in the placebo group. For the main blood vessel measure at 24 weeks, the LDMTX group showed an average change in FMD of +0.24 percentage points from their starting point, while the placebo group showed a change of +0.15 percentage points. At the earlier 12-week check, the reported data shows the LDMTX group had an average change of +0.32 percentage points in FMD, while the placebo group showed a change of −0.06 percentage points. For the secondary measure of reactive hyperemic flow rate at 24 weeks (how quickly blood rushes back through the artery after it is briefly restricted), the LDMTX group showed an average change of −11.40 cc/min and the placebo group showed +13.76 cc/min. Changes in resting artery diameter were small in both groups at both time points, as reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT01939197 · results posted 17 November 2017

  According to the results reported on ClinicalTrials.gov, this trial (NCT01939197) enrolled a total of 318 participants across several groups and phases. The trial was studying treatments for hepatitis C virus (HCV) infection, specifically looking at how many participants had no detectable virus in their blood 12 weeks after finishing treatment — a measure called SVR12 (sustained virologic response at 12 weeks). This is a standard way researchers check whether the virus remains undetectable after a course of treatment. The trial was conducted in multiple parts, testing different treatment combinations across participants with different strains (genotypes) of hepatitis C. The reported data shows that, for the main group of 200 participants in Part 2 with genotype 1 hepatitis C, 97% achieved SVR12 — meaning 97 out of every 100 participants in that group had no detectable virus at the 12-week post-treatment check. In the earlier testing phases (Part 1a), the reported SVR12 figures were 93.5% in one group and 90.6% in another. In Part 1b, both groups reported 100% SVR12. For participants with genotype 4 hepatitis C in Part 2, the reported SVR12 rate was 96.4%. Two smaller groups in Part 2 (Arms F and G) reported SVR12 rates of 75% and 80% respectively. Regarding virus rebounding during treatment in Part 1a, 0% of one group and 3.1% of the other group had a detectable rebound while still on treatment. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT00855413 · results posted 17 October 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 15 people who had recently been diagnosed with acute HIV infection — meaning they had been infected relatively recently. All 15 participants completed the study. The trial was measuring how the levels of HIV in participants' blood (called HIV RNA, sometimes referred to as "viral load") and immune cell counts (called CD4 cells, which are a key part of the immune system) changed over time after they began treatment. The reported data shows that, at 24 weeks into the study, 13 out of 15 participants had HIV RNA levels below 200 copies per millilitre of blood — the threshold the trial used to define a "virologic response" at that point. By 48 weeks, 9 out of 15 participants had HIV RNA levels below an even lower threshold of 50 copies per millilitre. Before starting treatment, the reported median (middle value) HIV RNA level across participants was 1,000,000 copies per millilitre. The reported data also shows that the median time it took for participants' HIV RNA levels to fall below 200 copies per millilitre was 59 days. Regarding CD4 immune cell counts, the reported median change from the start of the study to week 24 was an increase of 158 cells per cubic millimetre of blood, and from the start to week 48 the reported median increase was 349 cells per cubic millimetre. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT02063880 · results posted 25 July 2017

  According to the results reported on ClinicalTrials.gov, this trial (NCT02063880) involved 183 people in total — 90 in a group who started HIV treatment urgently (called "Urgent ART") and 93 in a group who started treatment a short time later (called "Early ART"). The trial was measuring death from any cause as its main outcome, and also tracked two other things: a condition called IRIS (where the immune system recovers but causes inflammation in the body) and side effects that might be linked to the medications. The reported data shows that, for the main outcome of death from any cause, 21 out of 90 participants in the Urgent ART group and 18 out of 93 participants in the Early ART group passed away during the study. For the first secondary outcome, 10 participants in the Urgent ART group and 12 in the Early ART group showed signs of IRIS (based on review by an independent panel). For the second secondary outcome, 23 participants in the Urgent ART group and 15 in the Early ART group experienced side effects that were considered potentially linked to their medications. The reported data also shows that 28 people in the Urgent ART group and 27 in the Early ART group did not complete the study, though the reasons for this were not broken down in the submitted results. No other outcome figures beyond those described above were included in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT00988442 · results posted 17 July 2017

  According to the results reported on ClinicalTrials.gov, this trial (NCT00988442) enrolled 59 people in total — 30 in a group that received enhanced nursing telephone support alongside standard care, and 29 who received standard care alone. The trial was looking at how well HIV was being controlled in people taking HIV medicines (antiretroviral therapy), and whether extra support from nurses over the phone made any difference to the numbers measured. The main thing the trial measured was how many participants had their HIV reduced to a very low level (fewer than 200 copies of the virus per millilitre of blood) at 48 weeks. The reported data shows that at week 48, 4 out of 30 people in the telephone support group and 5 out of 29 people in the standard care group had reached that low virus level. For the secondary measures, the reported data shows that 4 people in the telephone support group changed their HIV medicine regimen early, compared with 7 in the standard care group. Changes in CD4 cell count — a measure of immune system cells — were also tracked; at week 12, the telephone support group's count had risen by an average of 11 cells/mm³ and the standard care group's by 27 cells/mm³; at week 24 those figures were 37 and 9 respectively; and at week 48 they were 63 and 80 respectively. Regarding confirmed instances where the virus was not being adequately controlled at or after week 24, the reported data shows 16 participants in each group experienced this, though the breakdown of how those numbers were split across sub-categories was not clearly distinguishable in the submitted data. It is worth noting that very few participants were recorded as having completed the study in the formal sense — 0 in the telephone support group and only 1 in the standard care group — and no explanation for this was provided in the submitted results data, so caution is warranted when interpreting these figures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT00270296 · results posted 5 June 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 730 participants in total, spread across three treatment groups: 285 in the TZV arm, 275 in the Kaletra arm, and 170 in the NVP arm. The trial was measuring two main things in pregnant women living with HIV — how well each treatment kept the amount of HIV virus in the blood at a very low level (below 400 copies per millilitre of blood, which researchers call "virologic suppression"), and how many babies born to these women tested positive for HIV. The reported data shows that, looking at virologic suppression, 274 out of 285 participants in the TZV group, 256 out of 275 in the Kaletra group, and 160 out of 170 in the NVP group had their HIV levels brought below that threshold. For the second measure — HIV-positive infants — the reported data shows 6 infants in the TZV group tested positive for HIV, compared to 1 infant in the Kaletra group and 1 infant in the NVP group. It is worth noting that not all participants completed the study: 99 in the TZV group, 90 in the Kaletra group, and 61 in the NVP group did not finish. The reported data does not include further detail about why participants did not complete the study, and no additional outcome measures were reported beyond these two primary measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT00972725 · results posted 13 April 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 28 adults in total — 13 in a group that received an experimental malaria vaccine called GSK732461 together with an anti-malaria medicine called Nivaquine (chloroquine), and 15 in a group that received GSK732461 alone. All 28 participants completed the study with no one dropping out. The trial was measuring how the immune system responded to the vaccine — specifically, whether certain immune cells (called CD8+ T cells) became active against malaria-related proteins — and also tracking what symptoms and health events participants experienced after vaccination. The reported data shows that when looking at immune cell responses, only 1 participant in the combination group and 3 participants in the vaccine-only group showed a detectable CD8+ T cell response to at least one malaria protein; no participants in either group showed responses to two, three, or all four proteins measured. Regarding symptoms at the injection site, the reported data shows that all 13 participants in the combination group and 14 of 15 in the vaccine-only group reported at least one local symptom such as pain, redness, or swelling. For general symptoms like fatigue, headache, or gut upset, 9 of 13 in the combination group and 14 of 15 in the vaccine-only group reported at least one. Broader health events (called unsolicited adverse events) were reported by 8 of 13 and 13 of 15 participants respectively. The reported data shows that no participants in either group experienced a serious adverse event, and no participants experienced any of the specific immune-related disorders that were being monitored. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT01810289 · results posted 27 February 2017

  According to the results reported on ClinicalTrials.gov, this trial involved two groups of HIV-positive patients at clinics in what appears to have been a resource-limited setting. The first group — the "pre-intervention" group — included 7,277 people, and the second group — the "post-intervention" group — included 4,747 people. The trial was measuring whether a clinic-based program changed how quickly eligible patients started HIV treatment, and tracked several related outcomes including deaths, attendance at appointments, and virus levels in the blood. The reported data shows that, among patients who were eligible to start HIV treatment, 2,585 people in the pre-intervention group and 3,753 people in the post-intervention group went on to begin treatment within 14 days of becoming eligible. For the secondary outcomes, reported deaths (measured in a randomly selected sub-group one year after becoming treatment-eligible) were 3% in the pre-intervention group and 2% in the post-intervention group. Attendance at scheduled appointments within one year was reported at 84% in both groups. When a random sample of patients had their blood virus levels checked one year after becoming eligible for treatment, 58% of the pre-intervention group and 66% of the post-intervention group had their virus suppressed to a low level. No data was reported for the outcome measuring transmission of HIV from mothers to babies during pregnancy or birth. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT00249470 · results posted 16 December 2016

  According to the results reported on ClinicalTrials.gov, this trial involved 56 people in total, split evenly into two groups of 28. One group was called "Abstinence & Work" and the other "Work Only." All 56 participants completed the study — none dropped out. The trial was measuring cocaine use (through urine tests), opiate use (also through urine tests), and self-reported risky behaviours linked to HIV, such as injecting drugs or using crack cocaine. The reported data shows that, for the main measure — the percentage of urine samples that tested negative for cocaine — the Abstinence & Work group returned cocaine-negative results 29% of the time, compared with 10% for the Work Only group. For the opiate urine tests, the Abstinence & Work group had 55.4% of samples test negative for opiates, while the Work Only group had 62.5% negative. For the HIV risk behaviour measure, 28% of participants in the Abstinence & Work group reported no injection drug use or crack cocaine use, compared with 16.1% in the Work Only group. It is worth noting that these numbers are simply the figures submitted to ClinicalTrials.gov — they describe what was recorded during the trial for these two groups, and no further breakdown (such as how confident researchers were in the differences, or what other factors may have played a role) was included in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT02121795 · results posted 30 November 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 334 people in each of two groups — 668 participants in total. All participants were adults living with HIV-1 who were already on a stable HIV treatment regimen. The trial compared two different "backbone" medicines: one group took a combination called F/TAF alongside a third HIV medicine, and the other group took a combination called FTC/TDF alongside a third HIV medicine. The main thing the trial was measuring was how many people in each group had their HIV viral load (the amount of virus detectable in the blood) drop below 50 copies per millilitre of blood after 48 weeks — a level considered very low by clinical standards. The reported data shows that at 48 weeks, 94.3% of participants in the F/TAF group and 93.0% in the FTC/TDF group had a viral load below that 50-copies threshold. When an even lower threshold of 20 copies per millilitre was used, the reported figures were 91.6% for the F/TAF group and 90.9% for the FTC/TDF group at 48 weeks, and 83.5% versus 86.1% respectively at 96 weeks. The trial also measured bone mineral density (essentially, a measure of bone strength) at the hip and spine using a type of X-ray scan. The reported data shows that hip bone density changed by an average of +1.236% in the F/TAF group and −0.071% in the FTC/TDF group over 48 weeks; spine bone density changed by +1.662% and −0.109% respectively. A type of immune cell called CD4+ cells — higher counts generally indicate a stronger immune response in people with HIV — changed by an average of 20 cells per microlitre in the F/TAF group and 21 cells per microlitre in the FTC/TDF group over 48 weeks. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT00326963 · results posted 16 August 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 140 adults living with HIV-1 who were given a combination treatment including enfuvirtide alongside a protease inhibitor and other antiretroviral (HIV) medicines. The trial was measuring how well this combination reduced the amount of HIV virus detectable in participants' blood — known as "viral load" — at several points over 24 weeks. Of the 140 people who started, 107 completed the study and 33 did not. The reported data shows that the main goal of the trial was to count how many participants had a viral load below 50 copies per millilitre of blood (a very low, hard-to-detect level) at week 24. According to the results reported on ClinicalTrials.gov, around 79 participants (approximately 60%) reached this threshold at that point, depending on the analysis method used. At earlier time points, the reported figures were lower — around 21% at week 4 and roughly 49% at week 12 had viral loads below 50 copies/mL. The reported data also shows results using a less strict cut-off of 400 copies/mL: roughly 57% were below this level at week 4, around 68% at week 12, and approximately 72–73% at week 24. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT01107834 · results posted 20 July 2016

  According to the results reported on ClinicalTrials.gov, this trial involved 60 people in total — 30 healthy volunteers and 30 people who had been exposed to HIV and were taking a type of HIV medication known as HAART (a combination of antiretroviral drugs). All 60 participants completed the study with no dropouts. The trial used ultrasound scans of the heart (echocardiography) to compare various measures of how the heart was sized and how well it was pumping and relaxing between the two groups. The reported data shows the following numbers for the two main (primary) measures: the size of the heart's main pumping chamber relative to body size (left ventricular mass index) was recorded as 67 g/m² in the healthy group and 60 g/m² in the HIV/HAART-exposed group. The measure of how much the heart muscle shortens with each beat (fractional shortening) was 36% in the healthy group and 37% in the HIV/HAART-exposed group. For the additional (secondary) measures, the reported data shows: a measure of how the heart muscle deforms during a beat (global strain rate) was −22.3% in the healthy group and −21.1% in the HIV/HAART-exposed group; heart muscle speed during the pumping phase was 9.3 cm/s versus 9.1 cm/s; a ratio describing how the heart fills with blood in two stages during its resting phase was 2.1 versus 1.8; and the speed of the heart wall during the early relaxation phase was 16.3 cm/s versus 15.0 cm/s. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01449006 · results posted 20 May 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 17 people in total — 8 in the standard HIV treatment (HAART) group and 9 in the maraviroc group. The trial was looking at whether adding maraviroc to standard HIV treatment made any difference to brain and cognitive (thinking and memory) functioning in people living with HIV. It tracked participants at the start of the study, at 6 months, and at 12 months. Not everyone finished the study: all 9 people in the maraviroc group completed it, while 3 of the 8 people in the standard treatment group did not complete it. The reported data shows that the main thing being measured was overall thinking and memory performance, expressed as a score where lower (more negative) numbers indicate greater thinking difficulties. At the start, the standard treatment group scored –0.94 and the maraviroc group scored –0.81. At 6 months, the scores were –1.03 (standard treatment) and –0.51 (maraviroc). At 12 months, the scores were –0.93 (standard treatment) and –0.56 (maraviroc). The reported data also shows measurements of a marker of brain inflammation in spinal fluid (called neopterin), where both groups showed higher levels at 12 months compared to their starting levels (standard treatment: from 11.5 to 13.25 nmol/L; maraviroc: from 12.57 to 15.71 nmol/L). Additionally, brain chemistry ratios measured by a specialised brain scan (MRS) in two brain regions were recorded at baseline and 12 months for both groups; the reported numbers across all measured brain chemicals showed only small numerical differences between the groups and across time points. It is worth noting that this was a very small trial, and the numbers of participants who completed it were limited, which the trial itself does not comment on further in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT01815736 · results posted 14 April 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 963 people in the group that switched to a combination HIV medication called E/C/F/TAF, and 480 people who stayed on their existing HIV treatment. The trial was measuring how well each approach kept the level of HIV virus in the blood very low (below 50 copies per millilitre, a standard marker used in HIV care), as well as changes in bone density, kidney function, and some side-effect-related symptoms over time. The reported data shows that at the 48-week mark, 95.6% of participants in the E/C/F/TAF group and 92.9% of those staying on their existing treatment had HIV levels below that threshold. At 96 weeks, those figures were 92.8% and 89.1% respectively. For bone density — a measure of how solid bones are — the reported data shows the E/C/F/TAF group had an average increase of around 1.9% at the hip and 1.9% at the spine by week 48, while the group staying on existing treatment had small average decreases of around 0.1% at both sites. For a kidney marker called serum creatinine (a substance in the blood used to check kidney function), the changes reported were very small in both groups. Among participants who had previously been on a specific medication called efavirenz, those who switched to E/C/F/TAF reported an average improvement in a symptom score (covering dizziness, sleep, and concentration) of about 1.6 points out of 20, compared with about 0.1 points in the group that stayed on their existing treatment. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT02071082 · results posted 4 April 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 79 people across two groups: 4 people who had never been treated for either HIV or hepatitis B (called the treatment-naïve group), and 75 people who already had their HIV well-controlled with existing treatment (called the HIV-suppressed group). The trial was measuring how well a treatment kept HIV levels very low in the blood, and how well it reduced hepatitis B virus (HBV) levels in the blood. It also looked at whether a liver enzyme called ALT — which can be raised when the liver is under stress — returned to a normal range. These measurements were taken at 24 weeks and again at 48 weeks into the study. The reported data shows that at 24 weeks, 100% of participants in the treatment-naïve group and 94.4% in the HIV-suppressed group had HIV levels below the detectable threshold of 50 copies per millilitre of blood. For hepatitis B, 33.3% of the treatment-naïve group and 86.1% of the HIV-suppressed group had HBV levels below the detectable threshold at 24 weeks. At 48 weeks, the reported data shows 66.7% of the treatment-naïve group and 91.7% of the HIV-suppressed group had undetectable HIV levels, while the same proportions — 66.7% and 91.7% respectively — also had undetectable HBV levels at that point. The reported data also shows that at 24 weeks, 100% of the treatment-naïve participants who had an elevated ALT at the start had it return to a normal range, compared with 50% in the HIV-suppressed group. By 48 weeks, those figures were 66.7% and 40.0% respectively. It is worth noting that only 2 of the original 4 treatment-naïve participants and 68 of the original 75 HIV-suppressed participants completed the study, so the treatment-naïve group's numbers are based on very few people and should be interpreted with that in mind. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT01705574 · results posted 10 March 2016

  According to the results reported on ClinicalTrials.gov, this trial involved 583 adults with HIV-1 — 293 in one group and 290 in another — during the main double-blind phase (where neither participants nor researchers knew who received which treatment). The trial was measuring how well two different HIV medication combinations kept the amount of HIV virus in participants' blood below a very low level (less than 50 copies per millilitre of blood, which is considered undetectable). One group took a single combined tablet called STB, and the other took a combination called ATV+RTV+TVD. After the main phase, some participants continued into an open-label extension (where everyone knew what treatment was being given), running to a total of 96 weeks. The reported data shows that at the 48-week mark of the double-blind phase, 87.2% of participants in the STB group and 80.8% in the ATV+RTV+TVD group had HIV levels below the 50 copies/mL threshold. A measure of immune system health — called CD4+ cell count, which reflects the number of certain protective blood cells — rose from the starting point by an average of 221 cells/μL in the STB group and 212 cells/μL in the ATV+RTV+TVD group over 48 weeks. At 96 weeks, 84.5% of those who had been taking STB throughout still had HIV levels below that same threshold. During the open-label extension phase at week 48, 94.3% of one group and 86.8% of another still had undetectable HIV levels, with CD4+ cell counts also continuing to change across the groups — though the reported figures varied and some extension-phase data was not broken down in the same way as the main phase. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT01218802 · results posted 8 March 2016

  According to the results reported on ClinicalTrials.gov, this trial involved 147 participants who were split into two groups: 72 people received rosuvastatin (a cholesterol-lowering medicine) and 75 received a sugar pill placebo. The trial was measuring two things over roughly two years (96 weeks): changes in bone density (how solid and strong bones appear on a special scan called a DEXA scan) and changes in the thickness of the walls of arteries in the neck (called carotid IMT), which researchers used as a way to track a marker related to heart and blood vessel health. Not everyone finished the study — 62 people in the rosuvastatin group and 57 in the placebo group completed it. The reported data shows the following numbers for bone density change: the rosuvastatin group had an average change of −0.03% from their starting measurement, while the placebo group had an average change of −0.53%. For the artery wall thickness measurement, the rosuvastatin group had an average change of +1.21%, compared to +4.04% in the placebo group. These are simply the numbers that were recorded and reported — they describe what was measured in these two groups of participants during this particular trial. It is worth noting that the reported data does not include some additional details (such as measures of variability around these averages) that would normally help put the numbers in fuller context. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT01818596 · results posted 18 February 2016

  According to the results reported on ClinicalTrials.gov, this trial (NCT01818596) enrolled 252 people across two groups: 246 participants who had previously received HIV treatment (Cohort 1, "treatment-experienced") and 6 participants who had not previously received HIV treatment (Cohort 2, "treatment-naive"). The trial was measuring changes in kidney function and bone turnover markers over 24 to 48 weeks in people taking a combination HIV medication called E/C/F/TAF. Kidney function was tracked using a measure called eGFR — essentially an estimate of how well the kidneys are filtering the blood — calculated in three different ways. Of the 246 people in Cohort 1, 215 completed the study; all 6 in Cohort 2 completed it. The reported data shows that, at the 24-week mark, kidney function scores changed only slightly from where they started. Using one calculation method (Cockcroft-Gault), the average starting scores were around 55.6 and 60.2 for the two groups, with changes of –0.4 and –0.3 respectively (meaning very small decreases). Using a second method (CKD-EPI based on a protein called cystatin C), starting scores were around 69.7 and 70.2, with small increases of 3.8 and 3.9. A third method (CKD-EPI based on creatinine) showed starting scores around 54.1 and 54.4, with small decreases of –1.8 and –2.6. A smaller sub-group had their kidney function measured directly; the reported data shows a starting value of 60.1 mL/min, with a change of –0.6 at 24 weeks and +1.4 at a later time point. The reported data also shows changes in two markers related to bone turnover — substances in the blood that can reflect how quickly bone is being broken down or rebuilt. For the treatment-experienced group (Cohort 1), one marker (CTX) showed percentage changes of –3.9% at week 24 and –2.2% at week 48, while the treatment-naive group (Cohort 2) showed changes of +16.9% and 0.0% at those same time points. A second bone marker (P1NP) showed percentage changes of –12.98% and –25.29% in Cohort 1, and +6.44% and +2.27% in Cohort 2, at weeks 24 and 48 respectively. These are simply the numbers recorded — no conclusions about what they mean for health outcomes should be drawn from this summary alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT01511016 · results posted 27 January 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 17 people in total — 8 received a placebo injection and 9 received a hormone called metreleptin (a laboratory-made version of leptin, a naturally occurring substance in the body). Of those, 6 in the placebo group and 7 in the metreleptin group completed the study, with 2 people in each group not finishing. The trial was measuring how the body breaks down fat — specifically, how quickly it releases fatty acids into the bloodstream (called lipolysis) and how quickly it burns those fatty acids for energy (called fatty acid oxidation). It also looked at blood cholesterol, blood sugar levels, and insulin levels after a sugar drink. The reported data shows the following numbers for the two main (primary) outcomes related to fat breakdown. For total lipolysis (the overall rate at which fat is broken down and released), the placebo group measured 0.649 and the metreleptin group measured 0.767 (both in units of mmol of fatty acids per kilogram of body weight per hour). For net lipolysis (a slightly different measure of the same process), the placebo group measured 0.386 and the metreleptin group measured 0.508 in the same units. For the secondary outcomes, the reported data shows fatty acid oxidation (fat burning) at 0.239 for placebo and 0.214 for metreleptin; non-HDL cholesterol (a type of blood fat) at 136 mg/dL for placebo and 127 mg/dL for metreleptin; blood sugar response after a sugar drink (measured as a total area over two hours) at 6,268 for placebo and 6,647 for metreleptin; and insulin response after the sugar drink at 1,580 for placebo and 2,868 for metreleptin. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT01345630 · results posted 14 January 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 797 people in total — 396 in one group who received a combination called MVC+DRV/r, and 401 in another group who received FTC/TDF+DRV/r. Both groups were taking combinations of HIV medicines, and the trial was comparing the two regimens. The main thing the trial was measuring was the proportion of participants whose HIV levels in the blood dropped below 50 copies per millilitre (a very low, hard-to-detect level) at 48 weeks. It is worth noting that relatively few participants — 35 in one group and 42 in the other — were recorded as having formally "completed" the trial, with the majority recorded as "not completed" for various reasons. The reported data shows that, using a specific counting method set by the US Food and Drug Administration, 77.3% of participants in the MVC+DRV/r group and 86.8% of participants in the FTC/TDF+DRV/r group had HIV levels below 50 copies per millilitre at 48 weeks. Under this counting method, anyone with a missing result, or who stopped their treatment or dropped out for any reason, was counted as not having reached that level. The reported data also shows that, looking at side effects (called adverse events), 360 participants in the MVC+DRV/r group and 365 in the FTC/TDF+DRV/r group experienced non-serious side effects during the study. Serious side effects were recorded in 41 and 40 participants respectively. More severe (grade 3 or 4) side effects were reported in 65 participants in the MVC+DRV/r group and 71 in the FTC/TDF+DRV/r group. A total of 22 people in the MVC+DRV/r group and 23 in the FTC/TDF+DRV/r group stopped taking part in the trial because of side effects. These numbers describe what was recorded and reported — this summary does not draw any conclusions about whether one treatment was better or safer than the other. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT01497899 · results posted 8 January 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 171 people living with HIV who had not previously been on HIV treatment. Participants were randomly assigned to one of two treatment combinations — one containing a newer form of a medicine called TAF (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide, or E/C/F/TAF), and one containing an older form called TDF (E/C/F/TDF). The main thing the trial was measuring was how many people in each group had very low levels of HIV in their blood (fewer than 50 copies per millilitre) after 24 weeks. A separate open-label extension phase then continued with additional participants across all groups, though the primary results focus on the initial comparison between the two groups. The reported data shows that at the 24-week mark, 88.4% of people in the TAF group and 89.7% of people in the TDF group had HIV levels below that threshold. At 48 weeks, the reported figures were 88.4% for the TAF group and 87.9% for the TDF group. The reported data also shows changes in a type of immune cell called CD4+ cells (a marker of immune system health) — on average, CD4+ counts rose by around 165–179 cells per microlitre at week 24 and 177–204 cells per microlitre at week 48 across the two groups, compared to where they started. Changes in the amount of HIV in the blood (measured on a scientific scale) were also reported as broadly similar between the two groups at both time points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT01780506 · results posted 8 January 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 438 people in the E/C/F/TAF group and 434 people in the E/C/F/TDF group during the main double-blind phase, where neither participants nor researchers knew which treatment each person was receiving. A smaller follow-on open-label phase (where both parties knew the treatment) included around 90–95 people from each group. The trial was measuring whether people living with HIV could reach a very low, difficult-to-detect level of the virus in their blood — specifically below 50 copies per millilitre — and also tracked a type of immune cell called CD4+ cells, which are an indicator of immune system activity. The reported data shows that at the 48-week mark (roughly one year), 93.1% of participants in the E/C/F/TAF group and 92.8% in the E/C/F/TDF group had virus levels below 50 copies per millilitre. At 96 weeks, those figures were 89.2% and 88.2% respectively, and at 144 weeks (nearly three years), 86.9% and 83.1%. When a stricter cut-off of below 20 copies per millilitre was used, the reported proportions were 86.4% (TAF group) and 87.3% (TDF group) at week 48, 84.4% and 83.6% at week 96, and 84.6% and 80.1% at week 144. The reported data also shows changes in CD4+ immune cell counts from the start of the trial. In the E/C/F/TAF group, the average count rose by 235 cells per microlitre by week 48, 285 by week 96, and 323 by week 144. In the E/C/F/TDF group, the corresponding figures were 221, 271, and 310 cells per microlitre. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT01078233 · results posted 17 September 2015

  According to the results reported on ClinicalTrials.gov, this trial (NCT01078233) looked at people living with HIV who were taking raltegravir, an antiretroviral medication. In total, more than 6,600 participants were included across six overlapping groups: a "Raltegravir Cohort" (656 people taking raltegravir), a "Historical Cohort" (1,681 people whose data came from an earlier period), a "Concurrent Cohort" (3,199 people whose data was collected at the same time as the raltegravir group), and three combined groups drawn from these. The trial was measuring how often four specific events occurred — cancer (any type), serious liver problems, body-fat changes (known as lipodystrophy, meaning unusual loss or build-up of fat in certain parts of the body), and death from any cause. Results were recorded as the number of events for every 100 person-years of follow-up (a way of counting how many events happened after accounting for how long each person was observed). The reported data shows the following event rates per 100 person-years. For cancer of any type, the Raltegravir Cohort recorded 1.29 events, the Historical Cohort 1.17, and the Concurrent Cohort 0.81. For serious liver events, the figures were 0.11 (Raltegravir), 0.90 (Historical), and 0.28 (Concurrent). For body-fat changes, the reported rates were 0.15 (Raltegravir), 1.04 (Historical), and 0.64 (Concurrent). For deaths from any cause, the rates were 0.86 (Raltegravir), 1.27 (Historical), and 0.68 (Concurrent). These numbers describe how frequently each event was recorded in each group during the observation period; they do not on their own explain why any differences between groups may exist. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT01296815 · results posted 27 July 2015

  According to the results reported on ClinicalTrials.gov, this trial involved 14 people in total, split into two groups of 7. One group received HAART (a combination of HIV medications) on its own, while the other group received HAART together with injections of a medicine called bevacizumab. All 14 participants completed the trial. The study was measuring how many people in each group had a "complete response" — meaning their condition showed no remaining signs of disease according to a standardised assessment method called RECIST criteria. The reported data shows that in the HAART-only group, 1 out of 7 participants had a complete response. In the group that received HAART combined with bevacizumab injections, 3 out of 7 participants had a complete response. These are the figures as submitted by the trial sponsor. A secondary outcome measuring safety and side effects was listed as part of the trial, but no numerical data for that outcome was reported in the ClinicalTrials.gov results entry, so those figures are not available here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT01766076 · results posted 21 May 2015

  According to the results reported on ClinicalTrials.gov, this trial enrolled 30 adults in total, split into two groups of 15. It used a "crossover" design, meaning each group took both atorvastatin (a cholesterol-lowering medicine) and a placebo (a dummy pill with no active ingredient) at different times — one group took the active medicine first, then switched to the placebo, while the other group did the reverse. All 30 participants completed the trial. The trial was measuring changes in a marker of immune system activity in the blood — specifically, how active certain immune cells (called CD4 T-cells) were after 12 weeks on each treatment. The reported data shows that, after 12 weeks, the group taking atorvastatin had an average 60% change in the level of these activated immune cells, while the group taking the placebo had an average 21% change. These numbers represent the average percentage change from each person's starting level. No other outcome measures were included in the submitted results data. It is worth noting that the trial's results as submitted cover only this one measurement, and no additional details about side effects or other outcomes were reported in the data available on ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT00525733 · results posted 9 March 2015

  According to the results reported on ClinicalTrials.gov, this trial (NCT00525733) enrolled 40 people living with HIV-1, split into two groups: 14 people received a standard 3-drug therapy, and 26 people received an experimental 5-drug therapy. The trial ran for 48 weeks and was measuring how many participants in each group had no detectable HIV-1 in their blood (using a very sensitive test called the Single Copy Assay) at the end of that period. Not everyone who started the trial finished it — 3 people in the standard therapy group and 3 people in the experimental therapy group did not complete the study. The reported data shows that after 48 weeks, 3 out of the 14 participants in the 3-drug standard therapy group had no detectable virus in their blood using this sensitive test. In the 5-drug experimental therapy group, 9 out of 26 participants had no detectable virus. These are the raw numbers as submitted; no further breakdown or additional outcome measures were included in the reported data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT01686503 · results posted 5 February 2015

  According to the results reported on ClinicalTrials.gov, this trial looked at different ways of giving an inactivated polio vaccine (IPV) booster shot to adults. A total of 231 people were enrolled across four groups: one group received two-fifths of the standard dose injected into the skin (intradermal), another received one-fifth of the standard dose injected into the skin, a third received the full standard dose injected into the muscle (intramuscular), and a fourth received two-fifths of the standard dose injected into the muscle. Most participants completed the study — 65, 63, 64, and 32 people respectively finished across the four groups. The trial measured levels of polio-neutralising antibodies (proteins in the blood that can recognise the polio virus) before and after the booster shot. The reported data shows that before the booster, antibody levels across all four groups were broadly similar and relatively low. For the three polio virus types measured, starting levels ranged roughly from 11 to 53 units across the groups. After the booster shot, the reported data shows antibody levels rose considerably in all four groups. For the group receiving two-fifths of the standard dose injected into the skin, post-booster levels were reported as 1,715, 2,188, and 2,375 units across the three polio types. For the one-fifth intradermal group, levels were 976, 1,438, and 1,698. For the full-dose intramuscular group, levels were 1,249, 1,489, and 1,792. For the two-fifths intramuscular group, levels were 1,328, 1,938, and 2,075. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT01495702 · results posted 26 January 2015

  According to the results reported on ClinicalTrials.gov, this trial enrolled 439 people in total — 292 in the Stribild group and 147 in the NNRTI+FTC/TDF group (a comparison combination of HIV medicines). The trial was measuring how well each treatment kept the level of HIV in the blood (called "viral load") very low, specifically below 50 copies per millilitre of blood, at 48 weeks and again at 96 weeks. It also tracked changes in CD4+ cell counts — a type of immune cell often monitored in people living with HIV — over the same timeframes. The reported data shows that at 48 weeks, 93.4% of participants in the Stribild group and 88.1% in the NNRTI+FTC/TDF group had viral loads below the 50 copies/mL threshold. At 96 weeks, those figures were 86.6% for the Stribild group and 80.4% for the comparison group. For CD4+ cell counts, the reported data shows that at 48 weeks, the Stribild group's count had risen by an average of 56 cells per microlitre from their starting level, compared with 58 cells per microlitre in the comparison group. At 96 weeks, the reported increases were 83 cells per microlitre (Stribild) and 101 cells per microlitre (NNRTI+FTC/TDF). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT00708162 · results posted 6 November 2014

  According to the results reported on ClinicalTrials.gov, this trial enrolled 361 people in the elvitegravir group and 363 in the raltegravir group — both medicines being treatments for HIV. The trial was comparing how many people in each group reached and kept their HIV viral load (the amount of virus detectable in the blood) below certain thresholds over time. Participants went through a randomised phase (where they were assigned to one group or the other) and, for some, a follow-on open-label phase (where both the participant and their doctor knew which medicine they were receiving). The reported data shows that the main thing being measured was the proportion of people whose HIV viral load dropped below 50 copies per millilitre of blood by week 48. According to the results reported on ClinicalTrials.gov, 59.0% of the elvitegravir group and 57.8% of the raltegravir group reached this level. At week 96, those figures were reported as 47.6% and 45.0% respectively. When a slightly less strict threshold of 400 copies per millilitre was used, the reported data shows 68.1% (elvitegravir) and 67.2% (raltegravir) at week 48, and 57.0% versus 56.1% at week 96. A second measuring method (called the "Snapshot" approach, which looks at a single point in time rather than tracking changes over the whole period) reported similar figures: roughly 59–60% versus 57–58% at week 48, and around 52–53% in both groups at week 96. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT01565889 · results posted 1 October 2014

  According to the results reported on ClinicalTrials.gov, this trial had two parts. Part A enrolled 38 people who were living with HIV and were already taking antiretroviral (HIV) medicines. They were split into five smaller groups, each taking a different combination of HIV drugs alongside sofosbuvir (SOF), a hepatitis C medicine. The aim of Part A was to measure how the body absorbed and processed these drugs when taken together — in other words, to check whether the drug levels in the blood were affected by combining them. Part B enrolled 23 people who had both HIV and hepatitis C, and they received sofosbuvir together with two other hepatitis C medicines (pegylated interferon and ribavirin). Part B was measuring how many participants had no detectable hepatitis C virus in their blood 12 weeks after finishing treatment — a result known as SVR12. The reported data shows that in Part A, the drug-level measurements varied across the five groups. For sofosbuvir specifically, the total drug exposure over a dosing period (AUCtau, a measure of how much drug was in the bloodstream over time) ranged from about 628 to 2,269 units (h·ng/mL) depending on the group, and the peak blood concentration (Cmax, the highest level reached) ranged from roughly 285 to 1,229 ng/mL. Some measurements for certain drug combinations were not reported in the submitted data. For Part B, the reported data shows that 91.3% of participants (21 out of 23) had no detectable hepatitis C virus at 12 weeks after finishing treatment (SVR12). The same figure of 91.3% was also reported at both 4 weeks and 24 weeks after treatment ended. The reported data shows that 0% of participants experienced a viral breakthrough during treatment, while 8.7% experienced a viral relapse (the virus became detectable again after treatment ended). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT00947271 · results posted 17 September 2014

  According to the results reported on ClinicalTrials.gov, this trial enrolled 1,010 participants in total, split across four groups that each received a different combination of two DVDs (DVD 1 or DVD 2) and two types of assessment (Assessment 1 or Assessment 2). The trial was measuring how many sexual partners participants reported over the following year, checked at four points in time (3, 6, 9, and 12 months after the intervention). A secondary measure tracked how many participants were newly diagnosed with a sexually transmitted infection (STI) over that same year. Participation numbers dropped somewhat over time — by the 12-month check-in, roughly 183 to 195 people per group completed that stage, out of the 250–254 who started in each group. The reported data shows that the average number of sexual partners reported in the previous three months was fairly similar across all four groups at every time point. At 3 months, the reported averages ranged from about 2.04 to 2.19 partners; at 6 months, from about 1.92 to 2.18; at 9 months, from about 1.83 to 2.11; and at 12 months, from about 1.78 to 1.90. In other words, the numbers were close across groups at each check-in point throughout the year. For the secondary measure, the reported data shows the number of participants newly diagnosed with an STI across the full year of follow-up: 33 in the first group, 36 in the second, 46 in the third, and 36 in the fourth. No further breakdown of this figure (such as by type of infection or timing) was reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00976404 · results posted 12 September 2014

  According to the results reported on ClinicalTrials.gov, this trial involved 28 adults living with HIV who were already on standard HIV treatment. Participants were split into two groups of 14: one group received two additional HIV medicines (maraviroc and raltegravir), while the other received those same two medicines plus an experimental HIV vaccine (a DNA prime followed by a viral-vector booster shot). The trial was primarily measuring whether this approach could reduce the amount of HIV genetic material — called HIV DNA — hiding inside certain immune cells (white blood cells known as PBMCs) over 56 weeks. All 28 participants completed the study. The reported data shows that for the main outcome — change in HIV DNA levels in blood immune cells at week 56 — both groups showed virtually no change from their starting point. The medicines-only group had a change of 0.00 (on a logarithmic scale, meaning no measurable shift), while the vaccine group had a change of 0.04, also essentially flat. For HIV DNA measured in rectal tissue, the reported changes were similarly very small: +0.08 in the medicines-only group and −0.02 in the vaccine group. For a type of immune cell called CD4+ T cells (which help fight infection), the medicines-only group had an average change of −1 cell per mm³ and the vaccine group had a change of +23 cells per mm³. One immune response measurement — the body's T-cell activity against a part of the virus called Env — was reported as 28 units in the medicines-only group and 86 units in the vaccine group at week 36. The reported data also shows that serious adverse events (harmful reactions of grade 3 or 4, meaning significant or severe) considered related to the study treatments were recorded as 1 event in the medicines-only group and 3 events in the vaccine group; the data does not provide further detail about what those events were. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT00161382 · results posted 24 June 2014

  According to the results reported on ClinicalTrials.gov, this trial involved 1,445 participants in total — 598 in the intervention group and 847 in the control group. The trial was measuring whether a school-based program would influence the number of young people who began having sex (including vaginal, oral, or anal sex) by the time they reached ninth grade. Only students who reported no sexual experience at the start of the study were included in this part of the analysis. The study also intended to measure secondary outcomes including knowledge, self-confidence, attitudes, perceived social norms, and barriers related to sexual activity. The reported data shows that, among those who had not been sexually active at the start of the trial, 308 participants in the intervention group and 509 participants in the control group were recorded as having initiated sexual activity by the ninth-grade follow-up point. It is worth noting that not all participants completed the study — 249 people in the intervention group and 289 in the control group did not finish. As for the secondary outcomes (knowledge, self-confidence, attitudes, perceived norms, and barriers), no numerical results were reported in the data submitted to ClinicalTrials.gov, so those figures are not available to describe here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT01227824 · results posted 23 June 2014

  According to the results reported on ClinicalTrials.gov, this trial enrolled 411 participants in each of two groups — one taking dolutegravir (DTG, one tablet once a day) and one taking raltegravir (RTG, twice a day) — for a double-blind phase lasting 96 weeks, meaning neither participants nor researchers knew who was taking which medicine during that time. A separate open-label phase (where everyone knew which medicine was being taken) then followed for a further group of 338 participants, lasting a median of around 1,267 days. The trial was primarily measuring how many people in each group had their HIV-1 virus reduced to very low levels (below 50 copies per millilitre of blood) by 48 weeks. The reported data shows that by week 48, 88% of participants in the DTG group and 85% in the RTG group had HIV-1 levels below 50 copies per millilitre. Looking at a secondary measure at week 96, 332 participants in the DTG group and 314 in the RTG group had HIV-1 levels below 50 copies per millilitre. When a slightly higher threshold was used (below 400 copies per millilitre), the reported numbers at week 96 were 338 participants in the DTG group and 321 in the RTG group. The reported data also shows that when researchers looked for signs that the virus had developed resistance to the class of medicines used in this trial (called integrase inhibitors), they found this in 0 participants in the DTG group and 1 participant in the RTG group at week 48, and in 1 participant in the DTG group and 2 participants in the RTG group at week 96. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT01562886 · results posted 19 June 2014

  According to the results reported on ClinicalTrials.gov, this trial enrolled 14 adults who were taking a combination HIV treatment made up of rilpivirine and Truvada (a fixed-dose tablet containing two other HIV medicines). Thirteen participants completed the study, and one did not finish. The trial was looking at two things: how much of the drug rilpivirine was able to pass from the bloodstream into the fluid surrounding the brain and spinal cord (called cerebrospinal fluid, or CSF), and whether participants' HIV levels in the blood stayed below a detectable threshold during the study. The reported data shows that after 60 days on the treatment, the amount of rilpivirine measured in the cerebrospinal fluid was, on average, about 1.4% of the amount measured in the blood — meaning for every unit of the drug in the blood, roughly 1.4 units per 100 made it into the cerebrospinal fluid. For the second measure, the reported data shows that 2 out of the 13 participants who completed the study had HIV levels in their blood above 50 copies per millilitre — the point at which the virus becomes detectable using the test used in this trial. The results for the remaining participants were below that detectable level. No other outcome figures were included in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT00786422 · results posted 13 June 2014

  According to the results reported on ClinicalTrials.gov, this trial enrolled 25 participants, all of whom received the blood-thinning medication rivaroxaban (also known as Xarelto). The trial was measuring how the drug moves through the body (pharmacokinetics) and how it affects the blood's ability to clot (pharmacodynamics) in this particular group of patients. Of the 25 who started the treatment phase, 14 completed it, and 11 did not. A follow-up period then began with 20 participants, of whom 17 completed it. The reported data shows several measurements related to how rivaroxaban behaved in the body. A clotting test called prothrombin time (PT) — which measures how quickly blood clots — showed a starting (baseline) value of 15.8 seconds on average, and a calculated rate of change linked to drug levels of 0.0389 units. For the amount of drug in the bloodstream over a 24-hour period at steady levels, two sub-groups were reported: an initial treatment group (2,836 µg·h/L) and an extended treatment group (2,319 µg·h/L). The peak drug concentration in the blood was reported as 200 µg/L for the initial group and 167 µg/L for the extended group, while the lowest drug concentration during a dosing period was 42 µg/L and 35 µg/L respectively. The reported data also shows that 12% of participants experienced what the trial defined as "clinically relevant bleeding" overall, with 8% recorded for each of the two sub-categories (major bleeding, and non-major bleeding that still required some form of medical attention). No other outcome figures beyond these were included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT00142935 · results posted 6 June 2014

  According to the results reported on ClinicalTrials.gov, this trial involved 87 people in total who were about to be released from prison and had a history of opioid (heroin) use. They were divided into three groups to compare different approaches to connecting people with methadone maintenance treatment (a programme where people take daily doses of methadone to reduce dependence on heroin) in the community after release. The three approaches were: starting methadone while still in prison plus a referral and a payment after release (29 people); a referral and payment after release only (28 people); and a referral after release only, with no payment (30 people). By the end of the study, 26, 20, and 23 people respectively had completed their follow-up. The reported data shows that, looking at who attended their first community methadone clinic appointment within 30 days of release, 23 out of 29 people in the prison-start group did so, compared with 11 out of 28 in the referral-plus-payment group and 6 out of 30 in the referral-only group. Among those who did attend, the reported median number of days from release to that first appointment was 2 days in the prison-start group, 9 days in the referral-plus-payment group, and 5 days in the referral-only group. When participants were asked at the six-month interview whether they had injected illicit drugs in the past 30 days, 3 people in the prison-start group, 6 in the referral-plus-payment group, and 8 in the referral-only group said yes. The reported data also shows that, at the six-month interview, self-reported heroin use in the past 30 days was recorded for 6 people in the prison-start group, 8 in the referral-plus-payment group, and 11 in the referral-only group. Regarding overdoses, death records showed no fatal overdoses in the prison-start group, and one each in the other two groups within six months of release. Self-reported non-fatal overdoses in the six months prior to the interview were reported by 3, 3, and 2 people across the three groups respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT00110812 · results posted 12 May 2014

  According to the results reported on ClinicalTrials.gov, this trial enrolled 267 people living with HIV across three groups: 91 people who received no IL-2 (a type of immune-signalling protein), 89 who received IL-2 without antiretroviral therapy (ART — the standard HIV medicines), and 87 who received IL-2 alongside short courses of ART around the time of each IL-2 cycle. The trial was primarily measuring changes in CD4+ T cell counts — a type of immune cell that HIV affects — over 32 weeks. Most participants completed both the main study period and an extended follow-up phase. The reported data shows that, over 32 weeks, the average CD4+ T cell count changed by minus 21.8 cells per cubic millimetre in the no IL-2 group, rose by 113.7 in the IL-2 without ART group, and rose by 110.4 in the IL-2 with ART group. For secondary outcomes, the reported data shows that at 12 months the average CD4+ T cell count change was minus 8.4, plus 59.0, and plus 49.8 in each respective group. Regarding HIV levels in the blood (measured on a logarithmic scale, meaning small differences represent large real-world changes), changes from baseline were minus 0.39, minus 0.07, and minus 0.01 across the three groups. In terms of stopping IL-2 early (fewer than 3 cycles by week 32), 12 participants in the IL-2 without ART group and 32 in the IL-2 with ART group did so. Two participants in the IL-2 with ART group developed genetic changes in the virus associated with antiretroviral medicines. Fasting cholesterol levels were reported as 173.4, 167.0, and 164.6 mg/dl across the three groups respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT00869518 · results posted 21 April 2014

  According to the results reported on ClinicalTrials.gov, this trial (NCT00869518) enrolled 12 people in total — 6 in a group that received a medicine called rifabutin, and 6 in a group that received a placebo (a dummy treatment with no active ingredient). The trial was looking at whether rifabutin could clear a type of bacteria called *Staphylococcus aureus* from places on the body where it commonly lives, such as the nose, throat, and groin. Ten of the 12 participants completed the trial (5 in each group), with one person from each group not finishing. The reported data shows that for the primary outcome — which measured how many participants had the bacteria fully cleared at the main assessment point — the result was zero in both the rifabutin group and the placebo group. For one of the secondary (follow-up) outcome measures, which looked at bacterial clearance at a different time point, the reported data shows 3 participants in the rifabutin group and 1 participant in the placebo group had the bacteria cleared. Another secondary outcome measuring the same thing had no numbers reported in the data submitted to ClinicalTrials.gov. For the secondary outcome tracking whether participants had a return of skin infections, the reported data shows zero participants in either group experienced this during the follow-up period. It is worth noting that this was a very small trial, and some outcome data was not reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT01339416 · results posted 21 April 2014

  According to the results reported on ClinicalTrials.gov, this study followed 8,202 people who were receiving care for HIV. All 8,202 participants completed the study, with no dropouts recorded. The study was an observational registry — meaning researchers tracked what was already happening in clinical care rather than testing a specific treatment — and it measured how often certain serious health events occurred among people living with HIV over time. The unit used to express these rates is "per 100 person-years," which is a way of counting how many events happened for every 100 people followed over one year. The reported data shows the following event rates for the primary outcomes. For cancers, the overall rate of non-AIDS-defining cancers (those not directly linked to immune deficiency) was reported at 0.62 per 100 person-years, while AIDS-defining cancers occurred at rates of 0.30, 0.27, and 0.02 per 100 person-years across the specific types measured. For serious infections linked to immune deficiency (called AIDS-defining opportunistic infections), the reported rates across the different infection types ranged from 0.15 to 2.04 per 100 person-years, with the highest rate recorded for one particular infection category. Heart attack (myocardial infarction) was reported at 0.27 per 100 person-years, liver failure at 0.16 per 100 person-years, and viral encephalitis (inflammation of the brain caused by a virus) at 0.003 per 100 person-years. For the secondary outcome, the reported rate of rhabdomyolysis — a condition involving the breakdown of muscle fibres — was 0.10 per 100 person-years. The reported data does not identify which specific infection types correspond to each of the individual infection-rate figures listed, so a precise breakdown by infection name is not available from the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT00625404 · results posted 16 April 2014

  According to the results reported on ClinicalTrials.gov, this trial (NCT00625404) enrolled 2,120 people in total — 1,062 in the Truvada group and 1,058 in the placebo group (a placebo is a dummy pill with no active ingredient). The trial was measuring whether Truvada (a combination HIV medication taken as a daily pill) could reduce new HIV infections among participants, and it also tracked a range of blood test results and unwanted health events to see how the two groups compared over time. The reported data shows that when it came to new HIV infections, 33 people in the Truvada group and 35 people in the placebo group were recorded as becoming HIV-positive during the study. Regarding blood test findings, 4 people in the Truvada group and 2 in the placebo group had a confirmed kidney-related result (a measure called serum creatinine) reach a concerning level. Low phosphorus levels in the blood reaching a notable threshold were recorded in 45 people on Truvada and 40 on placebo. Elevated liver enzyme results (ALT) at a similar threshold were seen in 6 Truvada participants and 8 placebo participants, while another liver enzyme (AST) reached that level in 3 Truvada participants and 1 placebo participant. The total number of recorded unwanted health events during and shortly after taking the study product was 2,257 in the Truvada group and 2,384 in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT01414413 · results posted 7 April 2014

  According to the results reported on ClinicalTrials.gov, this trial involved two large community groups in what appears to be a study comparing two different approaches to HIV treatment (ART — antiretroviral therapy) start-up. One group of 8,194 adults lived in communities where HIV testing and treatment assessment could be done at home, while the other group of 8,466 adults lived in communities where people went to a clinic for those same steps. The trial was measuring things like how many people started HIV treatment, how many got tested for HIV at home, and how many people shared a positive HIV result with a community health worker. The reported data shows that during the first six months, 181 people in the home-based group started HIV treatment, compared to 63 people in the clinic-based group. When it came to home HIV testing over the first year, 5,287 people in the home-based group requested a test, compared to 4,433 in the clinic group. The reported data also shows that 490 people in the home-based group told their community counsellor they had a positive HIV result, compared to 278 in the clinic group. Regarding "loss to retention" — meaning people who started treatment but then dropped out of care within six months — 52 were recorded in the home-based group and 15 in the clinic-based group. For two other secondary outcomes — how well people stuck to their treatment (adherence) and adult death rates — no results data was reported on ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT01741350 · results posted 27 February 2014

  According to the results reported on ClinicalTrials.gov, this trial (NCT01741350) involved 304 participants in total — 149 in the CHRP group and 155 in a control condition. The trial was measuring two things: how well participants could demonstrate the correct steps for cleaning a needle or syringe (as a practical skills test, scored from 0–100%), and how safely they reported their own drug-use behaviour around sharing needles (scored on a scale of 0 to 4, where a higher number means safer reported behaviour). Participants were assessed at the start of the trial, then again at 4 weeks, 3 months, 6 months, and 12 months. The reported data shows that, at the start of the trial (before any intervention), both groups scored similarly on the needle-cleaning skills test — around 41% of correct steps for the CHRP group and about 43% for the control group. After the intervention (at the 4-week check), the CHRP group's score rose to roughly 76%, compared to about 53% for the control group. At 3 months the figures were approximately 70% versus 60%, at 6 months about 74% versus 63%, and at 12 months around 73% versus 64%. For the self-reported drug-use behaviour scale, the data shows scores at one recorded time point of 3.25 for the CHRP group and 3.39 for the control group, though the specific time point for this measurement was not clearly distinguished in the reported data. No additional time-point breakdowns for the behaviour scale were reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT01231516 · results posted 31 January 2014

  According to the results reported on ClinicalTrials.gov, this trial compared two HIV medications — dolutegravir (DTG, taken once daily) and raltegravir (RAL, taken twice daily) — in people living with HIV who had not previously been treated. A total of 360 people were assigned to the DTG group and 364 to the RAL group at the start of the blinded phase of the trial (where neither participants nor doctors knew which treatment was being given). The trial ran in two phases: a blinded phase up to 48 weeks, followed by an open-label phase (where the treatment was known) that continued up to around 480 weeks. The main thing being measured was the proportion of participants whose HIV levels in the blood dropped to an undetectable level (below 50 copies per millilitre) by week 48. The reported data shows that at week 48, 71% of participants in the DTG group and 64% in the RAL group had HIV levels below 50 copies per millilitre, as measured using a standardised counting method. At the earlier 24-week check, 281 out of 357 people in the DTG group and 252 out of 362 in the RAL group had reached that same low level. Using a slightly less strict threshold (below 400 copies per millilitre), the reported data shows that at week 24, 307 people in the DTG group and 287 in the RAL group met that measure; at week 48 those numbers were 278 and 257 respectively. The reported data also includes measurements of CD4+ cells — a type of immune cell that HIV affects — and how those counts changed over time. At the start of the trial, median CD4+ counts were around 204 cells per cubic millimetre in the DTG group and 193 in the RAL group. By week 48, both groups showed increases, with median counts of around 334 and 326 respectively. Additionally, the trial tracked how many participants whose virus was not being controlled developed signs that the virus had changed in ways that could make it harder to treat with this class of medication: this was reported in 4 participants in the DTG group and 17 in the RAL group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT00824421 · results posted 24 January 2014

  According to the results reported on ClinicalTrials.gov, this trial enrolled 195 people in total — 66 in the lersivirine 500 mg group, 66 in the lersivirine 750 mg group, and 63 in the efavirenz 600 mg group. All three groups were taking treatments for HIV-1 (the most common type of HIV). The main thing the trial was measuring was how many participants had the amount of HIV in their blood drop below a very low level (fewer than 50 copies of the virus per millilitre of blood) after 48 weeks. The trial also tracked this at earlier and later time points, and looked at other measures of how much virus was in the blood over time. The reported data shows that at the 48-week mark — the primary measurement point — 78.5% of participants in both the lersivirine 500 mg and lersivirine 750 mg groups had virus levels below that low threshold, compared with 85.7% in the efavirenz group. At 24 weeks, the reported figures were 83.1% for both lersivirine groups and 87.3% for efavirenz. By 96 weeks, the proportions were 70.8%, 67.7%, and 77.8% respectively. A similar pattern was seen when using a slightly higher threshold (400 copies per millilitre), and when using a separate analysis method that also accounted for people who stopped treatment or were lost to follow-up. The reported data also shows changes in the actual amount of virus measured in the blood (on a scientific scale used to handle very large numbers). Starting levels were similar across all three groups (around 4.6 on that scale). At 48 weeks, the average reduction was approximately 2.44 units in the lersivirine 500 mg group, 2.63 units in the lersivirine 750 mg group, and 2.68 units in the efavirenz group. These reductions were somewhat smaller by the 96-week mark across all groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT00931463 · results posted 17 January 2014

  According to the results reported on ClinicalTrials.gov, this trial (NCT00931463) enrolled 541 adults living with HIV — 271 in one group and 270 in the other. Both groups received the same base medication (ritonavir-boosted lopinavir), but one group also took two additional older HIV medicines (called 2N(t)RTIs), while the other group added a newer type of medicine called raltegravir instead. The trial's main goal was to measure how many people in each group had very low levels of HIV in their blood (fewer than 200 copies per millilitre) after 48 weeks. The reported data shows that at the 48-week mark, 219 out of 271 participants in the older-medicines group, and 223 out of 270 participants in the raltegravir group, had HIV levels below that threshold. The trial also looked at these numbers in several additional ways. When only participants who closely followed the trial rules were counted (known as the "per-protocol" group), the reported figures were 211 in each group. When the analysis applied a stricter rule — counting anyone with missing data or who stopped their assigned treatment as not reaching the target — the numbers were 208 and 210 respectively. Among participants who started with a higher amount of HIV in their blood (more than 100,000 copies per millilitre), the reported figures were 31 and 39. Among those who started with lower levels (100,000 copies or fewer), the figures were 188 and 184. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT01448486 · results posted 3 January 2014

  According to the results reported on ClinicalTrials.gov, this trial (NCT01448486) involved six people in total — three in a group receiving a medication called Raltegravir, and three in a group receiving a standard combination HIV treatment known as HAART. All six participants completed the study. The trial was measuring two things: changes in thinking and memory abilities (called neurocognitive function) over 12 months, and changes in a marker of brain inflammation found in spinal fluid (called cerebrospinal fluid neopterin). The reported data shows that thinking and memory abilities were scored using a system where lower (more negative) numbers indicate greater difficulty. At the start of the study, the Raltegravir group had an average score of −0.83 and the standard treatment group had −0.39. At six months, the scores were −0.55 (Raltegravir) and −0.48 (standard treatment). At 12 months, they were −0.47 (Raltegravir) and −0.54 (standard treatment). For the spinal fluid marker, the reported data shows the Raltegravir group had readings of 11.67 nmol/L at one time point and 17.00 nmol/L at another, while the standard treatment group had readings of 34.00 nmol/L and 12.00 nmol/L respectively. It is worth noting that with only three people in each group, these numbers reflect a very small number of participants. Because of the very small number of people involved, the reported figures give only a limited snapshot and should be interpreted with great caution. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT01309243 · results posted 27 November 2013

  According to the results reported on ClinicalTrials.gov, this trial enrolled 400 people in one group and 399 in another — just under 800 people in total. All participants were people living with HIV-1 who had not previously been treated. One group received a combination pill containing three medicines: emtricitabine, rilpivirine, and tenofovir (referred to here as FTC/RPV/TDF). The other group received a different three-medicine combination: efavirenz, emtricitabine, and tenofovir (EFV/FTC/TDF). The trial measured how many people in each group had very low levels of HIV in their blood (below 50 copies per millilitre, a level considered undetectable by the test used) at 48 weeks and again at 96 weeks, as well as some other blood measurements. The reported data shows that at 48 weeks — the main measurement point — 85.8% of participants in the FTC/RPV/TDF group and 81.6% in the EFV/FTC/TDF group had HIV levels below the 50 copies/mL threshold. At 96 weeks, the reported figures were 77.9% and 72.4% respectively. The reported data also shows changes in a type of immune cell called CD4 cells (a measure of immune system activity): on average, CD4 counts rose by 200 cells/μL in the FTC/RPV/TDF group and 191 cells/μL in the EFV/FTC/TDF group by week 48, and by 278 versus 259 cells/μL by week 96. For cholesterol, the reported data shows that fasting total cholesterol changed by an average of +1 mg/dL in the FTC/RPV/TDF group compared with +22 mg/dL in the EFV/FTC/TDF group at week 48; a type of cholesterol called HDL ("good" cholesterol) changed by +2 mg/dL versus +8 mg/dL in the same groups over the same period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT00242216 · results posted 17 October 2013

  According to the results reported on ClinicalTrials.gov, this trial compared two HIV medications — atazanavir and fosamprenavir — in a total of 76 participants (39 in the atazanavir group and 37 in the fosamprenavir group). The trial was measuring how well each medication reduced the amount of HIV virus in the blood, as well as changes in a key immune system marker called CD4 cell count (a type of white blood cell that helps the body fight infection). By the end of the study, 21 participants in the atazanavir group and 15 in the fosamprenavir group had completed the trial, with 18 and 22 respectively not completing it. The reported data shows that, for the main measure, 89% of participants in the atazanavir group and 73% of participants in the fosamprenavir group had their virus level fall below 400 copies per millilitre of blood — a threshold used in the trial to assess viral suppression. For the secondary measure, the atazanavir group had an average increase of 139 cells per cubic millimetre in their CD4 cell count from the start of the trial, while the fosamprenavir group had an average increase of 117 cells per cubic millimetre. These numbers reflect what was recorded and reported; they do not on their own tell us whether any difference between the two groups is meaningful. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT01092338 · results posted 18 September 2013

  According to the results reported on ClinicalTrials.gov, this trial looked at two different daily doses of Vitamin D3 supplements — 4,000 international units (IU) per day and 7,000 IU per day — in children with sickle cell disease. A total of 44 children took part, split evenly into two groups of 22. The trial was measuring two things: whether either dose raised a marker in the blood called 25D to a target level (32 ng/ml or above), and whether either dose caused a potentially harmful rise in blood calcium linked to very high 25D levels (above 160 ng/ml). The reported data shows that when it came to the blood calcium safety check, zero participants in either group had both elevated blood calcium and a 25D level above 160 ng/ml. For the second measure — reaching the target 25D blood level of 32 ng/ml or above — the reported data shows that 16 out of 21 children who completed the study in the 4,000 IU/day group reached that target level, and 19 out of 21 children who completed the study in the 7,000 IU/day group reached it. One child in each group did not complete the study, and no reasons were reported in the data for why they left. It is worth noting that this was a small study with just over 20 children in each group, and the data as submitted covers only these specific measurements. No other outcome figures were reported in the structured results on ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT00145795 · results posted 27 August 2013

  According to the results reported on ClinicalTrials.gov, this trial enrolled 20 people with HIV — 10 in each group. One group received a combination treatment called Kaletra added to their existing HIV medicines, while the other group continued on their current treatment without any change. The trial was measuring two main things: how much a key immune cell (called a CD4+ T cell — a type of white blood cell that HIV attacks) recovered over time, and how much of a certain type of cell death (called apoptosis, meaning cells dying off prematurely) was occurring in those immune cells at 3 and 6 months. The reported data shows that for the main outcome — CD4+ T cell counts (measured in cells per cubic millimetre of blood) — at 3 months, the Kaletra group recorded an average of 41.56 cells/mm³ compared to 49.40 cells/mm³ in the current-regimen group. At 6 months, the reported figures were 116 cells/mm³ for the Kaletra group and 32 cells/mm³ for the current-regimen group. For the secondary outcomes measuring the percentage of immune cells undergoing that premature cell death, the reported data shows figures ranging from roughly 10% to 19% across the different cell types and time points in both groups, with the specific numbers varying between the two groups at 3 and 6 months. Of the 20 participants who started, 19 completed the trial (one in the Kaletra group did not complete it; the reason was not reported in this data). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00312923 · results posted 15 July 2013

  According to the results reported on ClinicalTrials.gov, this trial enrolled 54 people in total — 28 in the treatment group and 26 in the control group. The trial was measuring levels of certain fats in the blood, specifically LDL cholesterol (often called "bad" cholesterol) and triglycerides (another type of fat found in the blood). Not everyone who started the trial finished it: 19 of the 28 people in the treatment group completed the study, as did 20 of the 26 people in the control group. The reported data shows that, at the end of the study, the average LDL cholesterol level was 116.34 mg/dl (milligrams per decilitre, a standard unit for measuring substances in blood) in the treatment group, compared with 118.84 mg/dl in the control group. For triglycerides, the reported average was 173.73 mg/dl in the treatment group and 186.69 mg/dl in the control group. These are simply the numbers recorded — no further breakdown of the results, such as how much these levels may have changed from the start of the trial, was included in the data reported to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT01018095 · results posted 15 July 2013

  According to the results reported on ClinicalTrials.gov, this trial involved 270 people in total — 135 in a group that received a 7-day course of treatment and 135 in a group that received a single dose. The trial was looking at Trichomonas vaginalis (a sexually transmitted parasitic infection, sometimes called "TV") and measuring how many participants still tested positive for the parasite after treatment. Not everyone finished the trial: 79 people in the 7-day group and 73 in the single-dose group completed it. The reported data shows that at the main "test of cure" check-up visit — the primary measurement point — 11 participants in the 7-day dose group tested positive for the parasite, compared with 21 participants in the single-dose group. At a later follow-up visit (the secondary measurement point), the reported data shows 8 participants in the 7-day dose group tested positive, compared with 19 in the single-dose group. These numbers reflect only the participants who returned for those visits, and the data does not include a breakdown of those who did not complete the trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT00613379 · results posted 31 May 2013

  According to the results reported on ClinicalTrials.gov, this trial involved 31 people in total, split across three groups of roughly 10–11 participants each (Arm 1: 10, Arm 2: 10, Arm 3: 11). All 31 participants who started the trial also completed it. The trial was measuring changes in the amount of HIV virus present in participants' blood (known as "viral load") after they began treatment — specifically, looking at the biggest change from their starting level during the course of the study. The reported data shows that viral load was measured on a "log10" scale, which is a way of expressing very large numbers more simply — a change of 1 on this scale represents a tenfold change in the actual number of virus copies. According to the results reported on ClinicalTrials.gov, the maximum change from the starting viral load was minus 1.67 log10 copies/mL in Arm 1, minus 1.83 log10 copies/mL in Arm 2, and minus 0.32 log10 copies/mL in Arm 3. A negative number indicates that viral load went down from the starting point during the study period. No other outcome measures were reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT00641641 · results posted 27 May 2013

  According to the results reported on ClinicalTrials.gov, this trial enrolled 16 participants, all of whom completed the study — none dropped out. The trial was looking at a drug intervention and measuring changes in the amount of HIV virus detected in participants' blood (known as "viral load"), which is expressed in a unit called log copies per millilitre. A higher number means more virus is present in the blood, and a lower number means less. The reported data shows that the primary outcome measured was the average change in HIV viral load from the start of the trial to across 12 follow-up assessments. The result reported was a value of 5.4 log copies per millilitre. It is important to note that this figure represents the average level measured, but the data as submitted does not make it straightforward to determine the direction of change (i.e., whether this reflects an increase or decrease from the starting point), and no secondary outcome measure data was reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT00796822 · results posted 17 May 2013

  According to the results reported on ClinicalTrials.gov, this trial enrolled 26 people in total — 13 in a group receiving a medicine called pentoxifylline and 13 in a group receiving a placebo (a dummy treatment with no active ingredient). The trial was looking at whether pentoxifylline had any effect on blood vessel function and on a marker of inflammation in the body. Ten of the 13 people in the pentoxifylline group completed the study, while all 13 in the placebo group completed it. The primary thing the trial measured was a change in something called "flow-mediated dilation" — a way of testing how well the inner lining of a blood vessel responds to increased blood flow, measured as a percentage change from the start of the study to week 8. The reported data shows that the pentoxifylline group had an average change of −1.93 percentage points, while the placebo group had an average change of −1.06 percentage points — meaning both groups showed a small decline in this measure over the eight weeks. The trial also measured a substance in the blood linked to inflammation (soluble TNF-Receptor I, reported in units called pg/mL). The reported data shows the pentoxifylline group had an average increase of 65.9 pg/mL in this marker, while the placebo group had an average decrease of 83.2 pg/mL. No further breakdown of these results — such as whether the differences between groups were considered statistically meaningful (i.e., unlikely to be due to chance) — was included in the data reported to ClinicalTrials.gov, so those figures cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT00931801 · results posted 11 March 2013

  According to the results reported on ClinicalTrials.gov, this trial enrolled 43 people in total across three groups: a Control Arm (14 people), Intervention Arm No. 1 (15 people), and Intervention Arm No. 2 (14 people). The trial was looking at whether people living with HIV who were already on a stable treatment regimen could maintain very low (undetectable) levels of the virus in their blood after switching to one of two alternative drug combinations involving raltegravir and atazanavir. The main thing being measured was whether the amount of HIV in participants' blood stayed below 40 copies per millilitre — a level considered "virologically suppressed" — over 48 weeks. The reported data shows that, of those who completed the study, all participants in the Control Arm (13 people) and Intervention Arm No. 1 (14 people) maintained that suppressed level of HIV at week 48, while 10 out of the 14 who completed Intervention Arm No. 2 did so. Three participants in Intervention Arm No. 2 did not maintain suppression, and one had a result that was not fully confirmed. For the secondary outcomes, the reported data shows that immune cell counts (CD4 cells, which help the body fight infection) changed modestly across groups over 48 weeks: the Control Arm recorded an average increase of about 75 cells per cubic millimetre, Intervention Arm No. 1 an increase of about 12, and Intervention Arm No. 2 a decrease of about 32. Across all participants combined, the average change was an increase of 21 cells per cubic millimetre. Regarding how well participants stuck to their prescribed doses (called adherence), all three groups reported very high levels at both the start and end of the study — between roughly 95% and 100% — with little to no change over 48 weeks. Quality of life was self-reported on a scale from 0 (death) to 100 (perfect health); at the start, scores ranged from about 77 to 93 across the three groups, and by week 48 those scores had changed only slightly — ranging from a decrease of 2.5 points to an increase of 0.8 points — with no large shifts reported in any group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT00414518 · results posted 20 February 2013

  According to the results reported on ClinicalTrials.gov, this trial (NCT00414518) involved 16 people in total — 7 in a group that had a planned break from HIV treatment (called a treatment interruption), and 9 in a group whose treatment was guided by their CD4 T cell count (a measure of immune system health). All 16 participants completed the study. The trial was measuring HIV virus levels in the blood at 24 weeks, the number of participants who experienced serious health events, and something called a "viral set point" — the level at which the amount of virus in a person's blood tends to stabilise after the immune system starts responding to HIV. The reported data shows that at 24 weeks, the average amount of HIV virus in the blood (measured on a logarithmic scale, meaning small differences in number represent large differences in actual virus amounts) was reported as 4.86 log10 copies per millilitre in the treatment interruption group and 4.26 log10 copies per millilitre in the CD4-guided therapy group. For the viral set point measure, the reported figures were 4.86 log10 copies per millilitre in the treatment interruption group and 4.24 log10 copies per millilitre in the CD4-guided group. Regarding serious health events — including AIDS-defining illnesses, severe side effects, or acute HIV illness — the reported data shows that 1 participant in each group experienced such an event. It is worth noting that with only 7 and 9 participants in each group respectively, this was a very small study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT01335191 · results posted 15 February 2013

  According to the results reported on ClinicalTrials.gov, this trial (NCT01335191) enrolled 27 participants in total — 16 people received a vaccine called TUTI-16 (at a dose of 1.0 mg) and 11 people received a placebo (an inactive substance used for comparison). All 27 participants completed the study with no dropouts recorded. The trial was measuring whether the body produced a particular type of immune response — specifically, the level of antibodies (proteins the immune system makes in response to something it encounters) targeting a component called "Tat," which is associated with HIV. The reported data shows that the primary outcome measured was the level of anti-Tat antibodies in the blood, expressed in nanograms per millilitre (ng/mL — a standard unit for measuring tiny amounts of a substance in blood). In the group that received TUTI-16, the reported average antibody level was 698 ng/mL. In the placebo group, the reported average antibody level was 4 ng/mL. No secondary outcome measure data appears to have been submitted or reported in the structured results available on ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT01102972 · results posted 31 December 2012

  According to the results reported on ClinicalTrials.gov, this trial (NCT01102972) enrolled 296 people in total — 199 in one group and 97 in another — who were living with HIV. The study compared two different combinations of HIV medicines: one group took abacavir/lamivudine plus atazanavir (ABC/3TC + ATV), and the other took tenofovir/emtricitabine plus atazanavir/ritonavir (TDF/FTC + ATV/RTV). The main thing the trial measured was the proportion of participants whose level of HIV in the blood (called "viral load") dropped below a very low threshold — 50 copies per millilitre — at 24 weeks. It also looked at this at 48 weeks, and at a slightly higher threshold of 400 copies per millilitre. The reported data shows that, at the 24-week mark using the primary method of counting results (called TLOVR — a way of tallying who responded and who did not over the course of the study), approximately 86.9% of participants in the ABC/3TC + ATV group and 86.6% in the TDF/FTC + ATV/RTV group had viral loads below 50 copies per millilitre. When the same threshold was looked at using alternative counting methods at 24 weeks, the reported figures ranged from about 84.9% to 94.5% for the first group, and from about 87.6% to 97.7% for the second group. At 48 weeks, the reported figures at the 50-copies threshold ranged from approximately 76.4% to 91.1% for the first group and from about 79.4% to 96.3% for the second group, depending on which counting method was used. The reported data also shows results for the higher threshold of 400 copies per millilitre. At 24 weeks, roughly 88.4% of the first group and 86.6% of the second group met this threshold using the primary counting method, with figures ranging up to about 98.9% under alternative methods for both groups. At 48 weeks, approximately 81% of the first group and 84% of the second group were reported as reaching that threshold. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT00665847 · results posted 21 December 2012

  According to the results reported on ClinicalTrials.gov, this trial (NCT00665847) enrolled 101 people who were taking a HIV treatment called TMC125 (also known as etravirine) combined with an individually tailored background HIV medication regimen. Of the 101 participants who started, 76 completed the study and 25 did not finish. The trial was measuring how often participants experienced new or worsening health events (called treatment-emergent adverse events) while on the medication over a 48-week period, as well as how the drug moved through the body and how many participants had very low levels of HIV virus in their blood at 24 weeks. The reported data shows that 89 out of 101 participants (about 88%) experienced at least one new or worsening health event during the treatment period. These events were rated on a scale from Grade 1 (least severe) to Grade 4 (most severe). The reported data shows that around 23% of participants had a Grade 1 event, approximately 33% had a Grade 2 event, about 27% had a Grade 3 event, and roughly 12% had a Grade 4 event. Regarding the virus levels in the blood at 24 weeks, the reported data shows that 52.5% of participants had HIV viral levels below 50 copies per millilitre of blood — a commonly used measurement point in HIV research. The trial also measured how the drug was absorbed and processed by the body, reporting average drug exposure over 12 hours of 5,216 ng·h/mL, a peak blood level of 589 ng/mL, and a trough (lowest point) blood level of 346 ng/mL. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT00090779 · results posted 18 December 2012

  According to the results reported on ClinicalTrials.gov, this trial enrolled 130 people living with HIV who had never previously been treated with antiretroviral (HIV) medicines. They were split into two groups: 66 people in the "IT Arm" (who received antiretroviral treatment for the first 36 weeks, then stopped) and 64 people in the "DT Arm" (who deferred, or delayed, starting treatment). The trial was measuring things like the level of HIV in the blood (called "viral load") and certain immune system counts (CD4 counts, which reflect how well the immune system is functioning) over a period of roughly 72–76 weeks off treatment. The reported data shows that for the main outcome — a ranking of HIV viral load levels at 72 and 76 weeks — the IT Arm had an average rank of 26.0, compared to 49.3 for the DT Arm. (A lower rank here indicates a lower viral load position within the group.) In a related primary measure using slightly different time points, the reported ranks were 26.0 for the IT Arm and 48.5 for the DT Arm. For a third primary measure, 2 participants in the IT Arm and 8 participants in the DT Arm experienced a serious HIV-related illness or a significant drop in their CD4 immune cells. On secondary measures, 7 people in the IT Arm and 23 people in the DT Arm met the criteria that would require them to start or restart HIV treatment. The reported data also shows small changes in CD4 counts over time in both groups, with the IT Arm showing slightly larger reductions, though all figures were modest. Eight people in the IT Arm stopped treatment before the 36-week point. It is worth noting that not everyone completed each stage of the trial — for example, in the first phase, 11 people in the IT Arm and 15 in the DT Arm did not complete that stage. The secondary outcome on CD4 count changes was reported across multiple time points, but the specific time points for each individual figure were not clearly labelled in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT00109590 · results posted 6 November 2012

  According to the results reported on ClinicalTrials.gov, this trial enrolled 175 women across three groups. All of the women had received a single dose of the HIV medicine nevirapine (NVP) during labour to reduce the risk of passing HIV to their babies — a common practice at the time. The trial was measuring whether adding a short course of another HIV medicine combination (lopinavir/ritonavir, or LPV/r) after delivery could reduce the chances of the virus developing resistance to nevirapine. Resistance means the virus changes in a way that could make a medicine less useful in future. The three groups were: women who took LPV/r for 7 days after birth (Arm A, 57 women), women who took no extra medicine (Arm B, 58 women), and women who took LPV/r for 30 days after birth (Arm C, 60 women). The reported data shows that, when looking at resistance detected at any point up to eight weeks after delivery, 7.1% of women in Arm A, 12.5% in Arm B, and 5.3% in Arm C had one or more new nevirapine resistance changes detected in their blood. When the measurement was narrowed to two specific time points (day 10 and week 6 after delivery), the reported figures were 3.6% in Arm A, 7.1% in Arm B, and 5.3% in Arm C. For a separate drug called LPV/r, a pharmacokinetic measurement (how much of the drug was present in the blood over time) was reported as 99.7 micrograms per hour per millilitre within 72 hours after delivery; the corresponding figure at day 30 was not reported in the data. For resistance to other medicines used in the study (ZDV, ddI, and LPV/r itself), the reported data shows figures of 0% or very close to 0% across the groups, with the exception of 1.78% in Arm B for one of those medicines. The reported data also shows that, among serious unwanted events (graded as severe or higher on a standard medical scale), 2 women in Arm A and 2 women in Arm C experienced such events, compared with 0 in Arm B. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT01106586 · results posted 22 October 2012

  According to the results reported on ClinicalTrials.gov, this trial enrolled 353 people in the Stribild group and 355 people in the ATV/r + FTC/TDF group (a combination of atazanavir boosted with ritonavir, plus two other antiviral medicines). The trial was measuring how well each treatment kept the amount of HIV in participants' blood below a very low level (fewer than 50 copies of the virus per millilitre of blood), which is often described as "undetectable." The trial tracked participants over roughly three and a half years, with check-ins at 48 weeks, 96 weeks, 144 weeks, and 192 weeks. It is worth noting that a large number of participants — 285 in each group — did not complete the full study period, though the reasons for this were not detailed in the data provided here. The reported data shows that at the 48-week mark (the trial's main measurement point), 89.5% of participants in the Stribild group and 86.8% in the ATV/r + FTC/TDF group had virus levels below the target threshold. At 96 weeks, those figures were 83.3% and 82.3% respectively, and at 144 weeks they were 77.6% and 74.6%. At the final 192-week check, the reported figures were 78.4% for Stribild and 73.1% for the comparison group. A separate measurement method (tracking whether participants reached and stayed below the threshold continuously) showed 86.1% and 84.8% at 48 weeks for Stribild and the comparison group respectively. The reported data also shows changes in participants' CD4 cell counts — a measure of immune system cells — from the start of the trial to each time point. In the Stribild group, the average increase was 207 cells per microlitre at 48 weeks, 256 at 96 weeks, 280 at 144 weeks, and 338 at 192 weeks. In the ATV/r + FTC/TDF group, the corresponding figures were 211, 261, 293, and 340 cells per microlitre. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT00772590 · results posted 24 August 2012

  According to the results reported on ClinicalTrials.gov, this trial (NCT00772590) enrolled 73 people across four groups. Each person received one of four treatments: a combination of Raltegravir (an HIV medication) and Hyper-immune Bovine Colostrum (a specialised supplement derived from cow's first milk after birth), Hyper-immune Bovine Colostrum alone, Raltegravir alone, or a placebo (a dummy treatment with no active ingredient). All 73 participants completed the study. The trial was measuring changes in CD4+ cell count — CD4+ cells are a type of immune cell that doctors monitor in people living with HIV, as they play an important role in the body's defences. The reported data shows the main outcome measured was the average change in CD4+ cell count from the start of the trial to the end, measured in cells per microlitre of blood. The group receiving both Raltegravir and Hyper-immune Bovine Colostrum had a reported average change of 8.62 cells per microlitre. The Hyper-immune Bovine Colostrum-only group showed a reported average change of 2.68 cells per microlitre. The Raltegravir-only group had a reported average change of 8.68 cells per microlitre. The placebo group had a reported average change of 21.87 cells per microlitre. No secondary outcome measure data was reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT00527618 · results posted 31 July 2012

  According to the results reported on ClinicalTrials.gov, this trial enrolled 34 people in total (16 in one group and 18 in the other). All participants had both HIV and genital herpes (HSV-2) infections. The trial used a "crossover" design, meaning each person took both medications at different times — one group started with acyclovir (400 mg twice daily) for 12 weeks, then switched to valacyclovir (1000 mg twice daily), while the other group did the reverse, with a two-week break in between. The trial was measuring the amount of HIV in the blood and the level of genital herpes activity while people were taking each medication. The reported data shows that the median level of HIV in the blood was 4.08 log10 copies per millilitre (a unit used to measure tiny amounts of virus) during the acyclovir period, and 3.68 log10 copies per millilitre during the valacyclovir period. For genital herpes activity, the proportion of daily swabs that detected the herpes virus was 8.2% on acyclovir and 7.8% on valacyclovir. The percentage of days on which participants recorded visible genital herpes sores was 4.0% on acyclovir and 1.0% on valacyclovir. When herpes virus was detected in swabs, the amount present was reported as 3.0 log10 copies per millilitre for both medications. A smaller sub-study also tracked how quickly HIV levels in the blood changed in the first three days of starting valacyclovir, reporting a decline rate of 0.20 log10 copies per millilitre per day. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT00055237 · results posted 26 July 2012

  According to the results reported on ClinicalTrials.gov, this trial enrolled 19 people in total across two groups. Seventeen participants had HIV-associated Kaposi's Sarcoma (a type of cancer linked to HIV infection), and two participants had Classic Kaposi's Sarcoma (the same cancer in people who do not have HIV). All 19 participants who started the study also completed it. The trial was primarily measuring how many participants showed a measurable reduction or disappearance of their cancer lesions (skin growths) after treatment. The reported data shows that, for the primary outcome — called the "response rate" — 31% of participants in the HIV-associated Kaposi's Sarcoma group showed either a partial response (meaning their lesions shrank or flattened by at least half for at least four weeks) or a complete response (meaning no detectable signs of the cancer remained for at least four weeks). This figure was only reported for the HIV-positive group; a response rate for the two participants with Classic Kaposi's Sarcoma was not reported in the data. For the secondary outcome, the reported data shows that all 19 participants across both groups experienced at least one adverse event (an unwanted or unexpected health occurrence during the trial), though a detailed breakdown of what those events were was not included in the summary data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT00098722 · results posted 16 May 2012

  According to the results reported on ClinicalTrials.gov, this trial investigated a medicine called maraviroc in people living with HIV. The trial had three groups during its main (double-blind) phase: one group took maraviroc once a day (186 people), another took it twice a day (194 people), and a third group took a placebo — a dummy pill with no active medicine (94 people). The trial went on to include open-label and observation phases involving additional hundreds of participants. The main thing the trial was measuring was the amount of HIV virus detectable in participants' blood (called "viral load"), specifically how much it changed over 24 and 48 weeks compared to where it started. The reported data shows that at the start of the trial, average viral load levels were similar across all three groups (around 4.84–4.89 on a logarithmic scale, which is a way of measuring very large or small numbers more manageably). After 24 weeks, the reported data shows the viral load had decreased on average by about 1.95 units (log scale) in the once-daily maraviroc group, about 1.97 units in the twice-daily maraviroc group, and about 0.93 units in the placebo group. At 48 weeks, the reported decreases were approximately 1.72, 1.87, and 0.76 units respectively. For the secondary outcomes, the reported data shows that at 24 weeks, roughly 55% of once-daily and 61% of twice-daily maraviroc participants had viral load below 400 copies per millilitre of blood, compared with about 23% in the placebo group; similar patterns were reported at 48 weeks. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT00982189 · results posted 18 April 2012

  According to the results reported on ClinicalTrials.gov, this trial enrolled 37 people in total, split across four groups of roughly nine to ten participants each. The four groups each received a different combination of two medications — lisinopril (a blood pressure medicine) and pravastatin (a cholesterol medicine) — or placebo substitutes for one or both. The trial was measuring three main things: whether participants reported experiencing side effects, whether they took more than 90% of their prescribed doses (checked by counting leftover pills), and whether a score used to estimate a person's 10-year risk of a heart-related event (called the Framingham Risk Score) changed over four months. The reported data shows that when it came to side effects, one person in the lisinopril-only group reported them, nobody in the pravastatin-only group did, two people in the group taking both medicines did, and one person in the group taking neither did. For pill-taking, the numbers who took more than 90% of their doses were: 2 out of 10 in the lisinopril-only group, 7 out of 9 in the pravastatin-only group, 5 out of 9 in the combined group, and 6 out of 9 in the no-active-medicine group. For the Framingham Risk Score, the reported changes from the start to month four were small reductions across all groups: roughly −1.6 percentage points in the lisinopril-only group, −0.7 in the pravastatin-only group, −1.5 in the combined group, and −0.3 in the no-active-medicine group. The reported data also shows small changes in blood pressure, blood cholesterol levels, and a measure of how flexible small blood vessels are, though the breakdown of those figures across all individual groups was not fully reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT00783614 · results posted 17 April 2012

  According to the results reported on ClinicalTrials.gov, this trial involved 22 people in total, split across four groups: those receiving antiretroviral therapy (ART — a treatment for HIV) plus aspirin (6 people), ART plus a placebo (a dummy pill with no active ingredient, 6 people), a deferred treatment approach plus aspirin (5 people), and deferred treatment plus placebo (5 people). All 22 participants completed the study. The trial was measuring two things: whether participants reported any side effects or new symptoms during the study, and various blood markers — substances in the blood that can indicate inflammation, blood vessel injury, and clotting activity. The reported data shows that when it came to self-reported side effects and adverse events (unexpected health changes), 1 person in the ART and Aspirin group reported experiencing something, as did 1 person in the Defer and Aspirin group. No side effects or adverse events were reported by participants in either of the placebo groups. As for the blood marker measurements — which were listed as a primary outcome — no numerical results were submitted to ClinicalTrials.gov, so those figures are not available to describe. Because the blood marker data was not reported, the picture from this trial is incomplete. The reported data shows only the side effect and adverse event counts described above. Given the very small number of participants across all four groups, it is worth noting that this appears to have been a small-scale study, and the numbers reflect only those 22 individuals. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT00474201 · results posted 9 April 2012

  According to the results reported on ClinicalTrials.gov, this trial enrolled 15 participants, and all 15 completed the study — none dropped out. The trial was looking at how a drug called gemfibrozil (commonly used to help manage cholesterol and triglycerides) behaves in the body under two different conditions: first, when taken on its own; and second, when taken alongside another medication called lopinavir-ritonavir (an HIV treatment). The key measurement was something called the "area under the curve" (AUC) — this is a way of estimating how much of the drug is present in the bloodstream over time. The reported data shows that when gemfibrozil was taken alone, the AUC measurement was 104 ng\*hr/mL. When gemfibrozil was taken together with lopinavir-ritonavir (after participants had been taking lopinavir-ritonavir for about two weeks), the AUC measurement was 62 ng\*hr/mL. In plain terms, these numbers represent how much gemfibrozil was circulating in the blood — the figure was lower when the two medications were taken together compared to when gemfibrozil was taken alone. No secondary outcome measures were included in the data reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT00686842 · results posted 5 March 2012

  According to the results reported on ClinicalTrials.gov, this trial involved 17 participants, all of whom were given a drug called PTC299, described as a VEGF inhibitor (a type of medicine designed to block a protein involved in blood vessel growth). All 17 participants who started the trial also completed it. The trial was primarily looking at the safety and side effects of PTC299, the highest dose that could be given without causing unacceptable side effects, and how well the treatment worked against the condition being studied. The reported data shows that out of the 17 participants, 7 experienced an adverse event (an unwanted or harmful reaction) rated as grade 3 or higher — meaning a serious or severe reaction according to a standard medical grading scale. For the other primary outcomes — the maximum tolerated dose and response to treatment — no numerical results were reported in the data submitted to ClinicalTrials.gov. Similarly, for the secondary outcomes, which looked at how the drug moved through the body, its effects on certain proteins in the blood, and its effects on HIV and a virus called KSHV, no figures were reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00426660 · results posted 17 October 2011

  According to the results reported on ClinicalTrials.gov, this trial enrolled 1,047 people, all of whom received the HIV medication maraviroc. Of those, 1,032 were included in the safety analysis, and 916 completed the study. The trial was designed to track a range of safety-related measurements in people taking maraviroc, including how often participants experienced serious side effects, abnormal blood test results, AIDS-defining illnesses (serious conditions that can occur when the immune system is severely weakened), and other HIV-related infections or cancers. The reported data shows that 13.2% of participants experienced a Grade 3 ("severe") adverse event — meaning a side effect serious enough to interrupt daily life — and 2.4% experienced a Grade 4 ("very severe") adverse event, defined as intolerable, irreversible, or life-threatening. When looking only at side effects considered possibly related to the study drug, those figures were 6.3% and 1.6% respectively. For abnormal blood test results, the reported data shows a range of figures across different tests: Grade 3 (severe) abnormalities ranged from roughly 0.2% to 4.7% depending on the specific test, while Grade 4 (very severe) abnormalities ranged from 0% to about 1.5%. The percentage of participants who developed AIDS-defining illnesses was low across the categories measured, with most figures reported at 0.1% to 0.6%. The reported data shows that no measurements were submitted for the two outcome measures examining AIDS-related infections and cancers broken down by starting viral load or CD4 cell count (a measure of immune system strength). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00543725 · results posted 12 July 2011

  According to the results reported on ClinicalTrials.gov, this trial compared two HIV medications — TMC278 (also known as rilpivirine) and efavirenz — in adults who had not previously been treated for HIV. A total of 340 people were assigned to the TMC278 group and 338 to the efavirenz group, giving 678 participants overall. The main thing the trial was measuring was how many people in each group had their HIV virus reduced to very low levels in the blood (fewer than 50 copies per millilitre) by week 48, using a specific counting method called TLOVR (which tracks the first time a person loses that low-level response and counts it as a failure from that point on). The reported data shows that at week 48 using the primary measurement method, 291 out of 340 participants in the TMC278 group and 276 out of 338 in the efavirenz group had virus levels below that threshold. The reported data also shows results at week 96: 269 in the TMC278 group and 258 in the efavirenz group still had low virus levels by that point using the same method. Using a second counting method (called a "snapshot," which simply looks at the most recent test result within a set time window), the reported figures were 281 versus 265 at week 48, and 259 versus 254 at week 96. For a broader threshold of fewer than 400 copies per millilitre at week 48, 300 people in the TMC278 group and 286 in the efavirenz group met that measure. At the final recorded visit after week 96, 260 people in the TMC278 group and 246 in the efavirenz group had virus levels below 50 copies per millilitre based on observed results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00272779 · results posted 9 May 2011

  According to the results reported on ClinicalTrials.gov, this trial enrolled 440 participants in one group and 443 in another — a total of 883 people living with HIV. Both groups took a combination of HIV medicines, but the two groups differed in which main drug was included: one group took atazanavir (ATV) once a day, and the other took lopinavir (LPV) twice a day. Both groups also took ritonavir, tenofovir, and emtricitabine. The trial's main goal was to measure how many participants in each group had the amount of HIV in their blood (called "viral load") fall below a very low level — fewer than 50 copies per millilitre — after 48 weeks. The reported data shows that at 48 weeks, 343 out of 440 participants in the atazanavir group and 338 out of 443 in the lopinavir group had viral loads below that very low threshold of 50 copies per millilitre. Using a slightly less strict measure (below 400 copies per millilitre), the reported numbers were 377 and 365 respectively. The reported data also shows that on average, both groups had similar reductions in the amount of virus in their blood from the start of the trial (a reduction of around 3.09 log units in the atazanavir group and 3.13 log units in the lopinavir group — a way of expressing a very large drop). A separate measure tracked immune cell counts (CD4 cells, which HIV attacks); the reported average increase from the start of the trial was 203 cells per cubic millimetre in the atazanavir group and 219 in the lopinavir group. The reported data also notes that among participants whose virus was not sufficiently controlled by the medicines (called "virologic failure"), small numbers in both groups showed changes in the virus that could affect how it responds to treatment — 27 such participants were identified in the atazanavir group and 26 in the lopinavir group for this analysis. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00112047 · results posted 13 October 2010

  According to the results reported on ClinicalTrials.gov, this trial enrolled 511 adults living with HIV — 257 in one group and 254 in another. Both groups took a medicine called efavirenz (EFV), but they were paired with different companion medicines: one group took emtricitabine and tenofovir disoproxil fumarate (FTC+TDF), while the other took a combination tablet called Combivir (CBV), which contains two different medicines. The main thing the trial was measuring was the proportion of participants in each group whose level of HIV in the blood (called "viral load") dropped below a certain threshold — 400 copies per millilitre of blood — by week 48 (roughly one year into the trial). After the main phase, a number of participants from both groups also entered a follow-on phase using a single combined tablet called Atripla. The reported data shows that, using a standardised counting method, 84.4% of participants in the EFV+FTC+TDF group and 72.8% of those in the CBV+EFV group had their viral load fall below 400 copies per millilitre by week 48. When a stricter cut-off of 50 copies per millilitre was used as a secondary measure, the reported figures were 79.5% and 70.4% respectively. The reported data also shows that the proportion of participants who lost that viral-load response by week 48 was 19% in the EFV+FTC+TDF group and 30% in the CBV+EFV group (using the 400 copies per millilitre threshold), and 23% versus 32% using the stricter 50 copies per millilitre threshold. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00524368 · results posted 22 September 2010

  According to the results reported on ClinicalTrials.gov, this trial (NCT00524368) compared two different dosing schedules of the same HIV medication — darunavir/ritonavir (DRV/Rtv). One group of 294 participants took 800/100 mg once a day, while another group of 296 participants took 600/100 mg twice a day. The trial's main goal was to measure how many people in each group had their HIV virus reduced to very low levels (fewer than 50 copies per millilitre of blood) by week 48. In total, 253 participants in the once-daily group and 248 in the twice-daily group completed the study. The reported data shows that by week 48, using a strict counting method called the TLOVR algorithm (which tracks whether low virus levels were maintained consistently over time), 212 out of 294 participants in the once-daily group and 210 out of 296 in the twice-daily group had virus levels below 50 copies/mL. Using a slightly less strict threshold of below 400 copies/mL, 226 and 227 participants respectively reached that level. The reported data also shows that the average time for participants to first reach very low virus levels was 85 days in both groups. The average reduction in the amount of virus in the blood from the start of the trial was reported as similar in both groups — a decrease of around 2.11 to 2.13 units on a scientific scale used to measure virus levels. The reported data also shows that for participants who initially responded but then saw their virus levels rise again, the average time before that loss of response occurred was around 250 days in the once-daily group and around 282 days in the twice-daily group. These figures only apply to those participants who experienced that outcome, and not all participants did. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00717067 · results posted 21 December 2009

  According to the results reported on ClinicalTrials.gov, this trial looked at how the body processes the drug maraviroc in people with different levels of kidney function. A total of 30 people took part, divided into five groups of six: healthy volunteers, people with mild kidney impairment, moderate kidney impairment, severe kidney impairment, and people with end-stage kidney disease (the most serious level, requiring dialysis). The trial measured how much of the drug entered the bloodstream, how high the drug level peaked, and how quickly that peak was reached — all ways of understanding how the body absorbs and clears a medicine. The reported data shows that the total amount of drug measured in the blood (called AUC, a way of tracking overall exposure over time) varied across groups. For people receiving multiple doses, the reported AUC figures were 7,356 ng·hr/mL for healthy subjects, 9,502 for those with mild kidney impairment, and 6,496 for those with moderate impairment. Among single-dose groups, healthy subjects had a reported AUC of 1,321, rising to 4,256 in the severe kidney impairment group, and around 2,637–2,770 in the end-stage kidney disease group (measured before and after dialysis). The reported peak drug levels (the highest concentration reached in the blood) followed a broadly similar pattern across groups, ranging from around 335–1,151 ng/mL depending on the group. The time it took to reach that peak was generally between 1 and 3 hours across all groups. A secondary measure — how much of the drug was not bound to proteins in the blood (and therefore "free") — was reported at roughly 15–32% across the different groups, with the data was not reported in a way that clearly separates the two sets of protein-binding readings for each group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01025830 · results posted 4 December 2009

  According to the results reported on ClinicalTrials.gov, this trial enrolled 20 adults in total — 8 in one group and 12 in another. It was a crossover study, meaning all participants took both versions of the medication at different times, with a 30-day "washout" break in between. The trial was comparing a generic HIV medicine called Triomune against the equivalent brand-name medicines (Zerit, Epivir, and Viramune), which contain the same three active ingredients: stavudine, lamivudine, and nevirapine. The main thing being measured was how much of each drug was absorbed into the bloodstream over time, and the secondary measure was the highest level each drug reached in the blood. The reported data shows the main absorption measure (called "area under the curve" — essentially a way of totalling up how much drug was in the blood over the full dosing period) was 3.6 for the generic stavudine compared to 3.4 for the brand version; 85.8 for generic nevirapine compared to 79.2 for the brand; and 5.2 for generic lamivudine compared to 6.4 for the brand. For the secondary measure — the peak blood level reached — the reported data shows 1.6 mg/L for generic stavudine versus 1.3 mg/L for brand; 8.8 mg/L for generic nevirapine versus 8.4 mg/L for brand; and 1.0 mg/L for generic lamivudine versus 1.3 mg/L for brand. These figures describe how the drugs were measured to behave in the bloodstream across the two formulations. No data was reported regarding any other outcomes beyond these absorption and peak-level measurements. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00443729 · results posted 19 November 2009

  According to the results reported on ClinicalTrials.gov, this trial enrolled 355 people in total — 176 in one group and 179 in the other. Participants were randomly assigned to take either MK0518 (also known as raltegravir) at 400 mg twice daily, or KALETRA™ (lopinavir/ritonavir) at 400/100 mg twice daily. The trial was measuring how many people in each group had their HIV viral load (the amount of HIV in the blood) fall below a very low level — 50 copies per millilitre — after 24 weeks. It also tracked unwanted health events (called adverse experiences) that occurred during that time. The reported data shows that at the 24-week mark, 154 out of 176 participants in the MK0518 group and 167 out of 179 in the KALETRA™ group had HIV levels below 50 copies per millilitre. Regarding unwanted health events over 24 weeks, the data reported that 123 people in the MK0518 group and 112 in the KALETRA™ group experienced at least one such event. The reported data also shows that 4 people in the MK0518 group and 8 in the KALETRA™ group had a serious adverse health event. When investigators assessed which events appeared related to the study drugs, 23 people in the MK0518 group and 35 in the KALETRA™ group were recorded as having a drug-related event. No deaths were reported in either group by the end of the 24-week period, and no serious drug-related adverse events were reported in either group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00054717 · results posted 19 November 2009

  According to the results reported on ClinicalTrials.gov, this trial enrolled 630 people in total — 313 in the tipranavir (TPV) plus low-dose ritonavir group, and 317 in the comparator protease inhibitor (CPI) plus low-dose ritonavir group. All participants were taking HIV medications, and the trial was looking at how well each combination kept the amount of HIV virus in the blood at a meaningfully lower level than before treatment started. The main things being measured were the proportion of people who achieved this viral reduction by week 48, and how long it took before the treatment stopped working for each person. It is worth noting that a large number of participants did not complete the full study — 262 in the tipranavir group and 299 in the comparator group did not finish. The reported data shows that by week 48, approximately 33.8% of people in the tipranavir group met the definition of a "treatment response" (meaning their virus levels stayed sufficiently reduced), compared with 16.2% in the comparator group. For the measure of how long it took before treatment stopped working, the reported figures were 113 days on average for the tipranavir group and 0 days for the comparator group — a figure of 0 days means that, on average, participants in the comparator group never achieved the required viral reduction in the first place. At earlier time points, the reported data shows the tipranavir group also had higher percentages of treatment response: at week 2 (53.1% vs 34.3%), week 4 (52.4% vs 33.3%), week 8 (52.4% vs 33.3%), and week 24 (41.8% vs 23.9%). These figures represent the numbers as submitted by the trial sponsor and do not account for the large number of participants who left the study early, which the reported data does not fully explain. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00293254 · results posted 30 September 2009

  According to the results reported on ClinicalTrials.gov, this trial enrolled 232 people in the raltegravir group and 119 people in a placebo (dummy treatment) group. Both groups also received what is called an "optimised background therapy" (OBT) — meaning a personalised combination of other HIV medicines chosen for each person. The trial was measuring the proportion of participants whose HIV viral load (the amount of HIV detectable in the blood) dropped below certain levels at various points over several years. A lower viral load reading is what the trial was designed to track. The reported data shows that at Week 16, 77.3% of participants in the raltegravir group had HIV levels fall below 400 copies per millilitre of blood, compared with 42.9% in the placebo group. At Week 48, those figures were 71.1% and 37.8% respectively. At the much later point of Week 156 (around three years in), the reported percentages were 50.2% for the raltegravir group and 21.0% for the placebo group. By Week 240 (roughly four and a half years), the reported figures were 45.7% and 13.4%. Using a stricter cut-off of below 50 copies per millilitre — a harder-to-reach target — the reported data shows 62.0% versus 36.1% at Week 16, and 59.6% versus 34.5% at Week 48. It is worth noting that the number of participants still in the trial reduced over time, which is common in long-running studies, and this can affect how figures from later time points should be interpreted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00262522 · results posted 20 August 2009

  According to the results reported on ClinicalTrials.gov, this trial involved people living with HIV-1 and compared two different forms and dosing schedules of a HIV medication called lopinavir/ritonavir (LPV/r). In the first eight weeks, around 166–167 people were in each of four groups, comparing a tablet form versus an older capsule form, taken either once a day or twice a day. After the eight-week comparison period, the two capsule groups were discontinued, and the trial continued with just the two tablet groups (roughly 333 people per group) out to 96 weeks. The trial was measuring how often participants experienced diarrhoea in the first eight weeks, how many had very low levels of HIV in their blood at 48 and 96 weeks, and how immune cell counts (a measure of immune health) changed over time. The reported data shows that during the first eight weeks, diarrhoea was recorded in 49.1% of participants taking the once-daily tablet, 54.8% taking the once-daily capsule, 44.6% taking the twice-daily tablet, and 49.7% taking the twice-daily capsule. At 48 weeks, 77.2% of people in the once-daily tablet group and 75.8% in the twice-daily tablet group had HIV levels in their blood below 50 copies per millilitre (a very low, hard-to-detect level). At 96 weeks, those figures were 64.9% and 69.2% respectively. The reported data also shows that average immune cell counts (CD4+ T cells, a type of white blood cell important in fighting infection) rose from the start of the trial by an average of 238.4 cells per microlitre in the once-daily tablet group and 254.0 cells per microlitre in the twice-daily tablet group by week 96. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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Not medical advice. These are results as reported by the trial sponsor to a public registry, summarised in plain English. They describe what a trial recorded, not whether a treatment is suitable for any person. Verify anything important against the original registry record and discuss what it means for you with your doctor.