Phase 2 HIV and AIDS Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults between 18 and 60 years old, of any gender
• People with a body mass index (BMI) between 18.5 and 29.9, and a body weight of at least 50 kg for men or at least 45 kg for women
• People who have already been diagnosed with HIV-1 infection and have never taken any anti-HIV medications or received any HIV-related vaccines
• People who are willing to avoid taking other anti-HIV medications throughout the trial period (from signing the consent form through to the Day 13 sample collection)
• People whose CD4 cell count (a measure of immune system health) is above 200 cells per microlitre at the screening visit
• Women who could become pregnant must have a negative pregnancy test at screening, be using effective non-medication contraception, and be willing to continue using effective contraception from the time of signing the consent form until 3 months after the last dose; men must be willing to use effective contraception and avoid fathering children during the trial and until 3 months after the last dose, or must have had a surgical sterilisation procedure
• People who understand the trial and are willing to sign the informed consent form

Who may not be able to join:

• People diagnosed with acute (very recent) HIV-1 infection, or who have an AIDS-defining illness at the time of joining, or who had an opportunistic infection (an infection that occurs when the immune system is weakened) in the 3 months before joining and whose condition was still unstable in the 4 weeks before joining
• People who received HIV prevention medication (pre-exposure prophylaxis or post-exposure prophylaxis) within 1 month before the screening visit
• People who have a serious ongoing health condition affecting the heart, lungs, digestive system, hormones, nerves, blood, or immune system that is not well controlled, as assessed by the trial doctor
• People with high blood pressure (resting reading of 140/90 mmHg or above), a very fast heart rate (above 100 beats per minute), a very slow heart rate (below 50 beats per minute), an abnormal heart rhythm reading on an ECG, or high fasting blood sugar levels
• People with a history of a severe, life-threatening allergic reaction to medications (such as aspirin or certain antibiotics), medication ingredients (such as lactose or gelatin), or foods, or people with ongoing allergic conditions requiring medication such as asthma, hives, or eczema
• People who had major gastrointestinal (digestive system) surgery in the 6 months before screening, or any surgery that could affect how the body processes medication, or who have planned surgery scheduled during the trial period (confirm with trial site for exceptions such as simple appendix or gallbladder removal)
• People with a history of cancer, with limited exceptions for certain treated skin cancers or treated cervical carcinoma in situ (confirm with trial site)
• People who test positive for hepatitis B surface antigen, active syphilis, or hepatitis C antibodies at screening, or who previously received interferon treatment for hepatitis B that led to a change in their hepatitis B status
• People whose blood test results at screening show low haemoglobin, low white blood cell count, low neutrophil count (a type of infection-fighting blood cell), or low platelet count
• People whose liver function blood tests at screening show results significantly above the normal range
• People whose kidney function blood tests at screening show results above the normal range or reduced kidney filtration capacity
• People who have smoked more than 5 cigarettes a day on average in the 3 months before screening, or who are unwilling to stop using tobacco products during the medication and sample collection periods
• People who have consumed more than 14 units of alcohol per week on average in the 3 months before screening, who test positive for alcohol at screening or baseline, or who are unwilling to avoid alcohol during the in-hospital stay
• People who regularly drink more than 8 cups of tea, coffee, or other caffeinated drinks per day on average in the 3 months before screening, or who are unwilling to avoid these drinks during the in-hospital stay
• People who consumed pitaya (dragon fruit), mango, pomelo, starfruit, or products made from them, or foods and drinks containing xanthine, caffeine, or alcohol (including chocolate, tea, coffee, cola, or cocoa) within 48 hours before the first dose, or who are unwilling to avoid these during the in-hospital stay
• People with a history of drug misuse or addiction in the 5 years before screening, or who test positive on a urine drug screen at screening or baseline
• People who cannot tolerate blood draws, have a fear of needles or blood, have donated blood or experienced significant blood loss (400 mL or more) or received a blood transfusion in the 3 months before screening, or who plan to donate blood during the trial
• People who have specific dietary requirements that would prevent them from following the standardised diet provided during the trial
• People who have taken part in another clinical trial involving an investigational drug or medical device within the 3 months before screening
• Women who are pregnant or breastfeeding at screening, or who have a positive pregnancy test at screening
• People (women or men) who are planning to have a child or donate eggs or sperm from 1 month before signing the consent form until 3 months after the last dose, or who are unwilling to use effective contraception or abstain from heterosexual activity during this period
• People who have taken any prescription medications, over-the-counter medications, herbal medicines, or health supplements in the 14 days before the first dose
• People whom the trial doctor considers unsuitable for participation for any other reason

Important: Always verify eligibility with the trial site directly before applying.