Phase 1 HIV and AIDS Trial, Recruiting

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

Who might be able to join this trial:

• People aged 18 to 75 years old.
• People who are able to give informed consent and are willing to follow all study procedures for the full duration of the trial.
• People who are in generally good health and already have a regular doctor managing their HIV care, and who are willing to keep seeing that doctor throughout the study.
• People with a confirmed HIV-1 infection.
• People whose HIV reservoir (the amount of HIV DNA stored in certain immune cells) is above a specific level — greater than 300 copies per million CD4+ T cells.
• People whose CD4+ T cell count (a measure of immune system health) is above 200 cells/mm³ at the screening visit.
• People who have been on HIV treatment (antiretroviral therapy, or ART) continuously for more than 3 years, with their HIV viral load kept undetectable (below 40 copies/mL). People who have had no more than 2 temporary low-level rises in viral load (called "blips") in the 48 weeks before screening may still be eligible, as long as those blips were no higher than 200 copies/mL and the viral load returned to undetectable afterwards.
• People who can become pregnant must have a negative pregnancy test at screening and again within 48 hours before the first study dose.
• People who can become pregnant must agree to use an accepted form of contraception during sexual activity that could result in pregnancy, starting 10 days before the first dose and continuing through the study follow-up period. Accepted methods include a contraceptive implant, an intrauterine device (IUD) or intrauterine system, a combined oral contraceptive pill (containing both oestrogen and progestogen), an injectable progestogen, a contraceptive vaginal ring, or a contraceptive patch.

Who may not be able to join:

• People who have had a serious AIDS-related illness in the 3 years before enrolling.
• People who have taken high-dose steroid medications (such as prednisone at more than 20 mg per day for more than 14 days), immune-suppressing cancer treatments, interleukins, systemic interferons, chemotherapy, or similar medications considered significant by the study doctor, in the past 6 months.
• People with a significant ongoing or serious medical condition other than HIV — such as autoimmune diseases, cirrhosis (serious liver scarring), or an active cancer that may need chemotherapy or radiation — if the study doctor considers this would prevent safe participation.
• People with active hepatitis B or hepatitis C infection detected by specific blood tests. Note: people who have a positive hepatitis C antibody result but a negative hepatitis C RNA test may still be eligible.
• People who are pregnant or breastfeeding.
• People who have received a licensed vaccine (such as a flu, hepatitis B, or pneumococcal vaccine) within 2 weeks before enrolling.
• People who have taken part in another experimental study or received an experimental non-HIV vaccine within 28 days before enrolling, or who plan to do so at any point during this study.
• People who have taken systemic (whole-body) immune-suppressing medications within the 3 months before enrolling. Some exceptions apply, including steroid nasal sprays or inhalers, mild topical steroid creams for skin conditions, short courses of oral or injected steroids for a one-off non-recurring condition (completed at least 30 days before enrolling), and cyclosporine eye drops.
• People with active problems related to drug or alcohol use, or other behaviours that the study doctor believes would make it difficult to follow the study requirements.
• People whose blood test results fall outside acceptable ranges, specifically: very low white blood cell counts, low haemoglobin (indicating anaemia), low platelet counts, elevated liver enzyme levels (ALT or AST), elevated bilirubin, or significantly reduced kidney function (confirm specific thresholds with the trial site).
• People who are unable to undergo a procedure called leukapheresis (a process of collecting certain blood cells) due to poor vein access or other medical reasons.
• People currently taking certain specific medications, including some heart rhythm medications, blood thinners, seizure medications, certain HIV medications, tuberculosis antibiotics, certain steroids, ergot-based medications, the herbal supplement St. John's Wort, certain cholesterol-lowering medications (lovastatin or simvastatin), certain pain medications (including fentanyl, oxycodone, buprenorphine, methadone, tramadol, and naloxegol), certain erectile dysfunction medications (sildenafil, tadalafil, vardenafil), and certain sedative medications (oral midazolam or triazolam). (Confirm the full list with the trial site.)
• People with any other medical findings that the study doctor believes could pose a risk, interfere with following study requirements, or affect the study results.
• People already enrolled in another trial or protocol involving apheresis (a blood cell collection procedure), unless it is an observational study. Enrolment in another interventional trial would require approval from the principal investigator.

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