Phase 1 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:

• People who have a confirmed HIV-1 diagnosis
• People aged between 18 and 70 years old at the time of the screening visit
• People whose CD4+ T cell count (a measure of immune system health) is above 300 cells per microlitre at screening
• People who have never taken HIV treatment (antiretroviral therapy) before screening
• People who are able to understand and agree to take part in the study
• People who are willing and able to take HIV treatment consistently throughout the entire study
• People who agree to use condoms during all sexual activity where there is still a risk of passing on HIV — that is, until their HIV levels are fully undetectable on treatment
• People who agree not to attempt to conceive a child during the study, including through methods such as sperm donation, IVF, or egg donation

Who may not be able to join:

• People who have previously or are currently taking a type of cancer drug called a BCL-2 antagonist or similar pro-apoptotic (cell-death-triggering) agent
• People where there is evidence or strong reason to believe their HIV was acquired while they were actively taking pre-exposure prophylaxis (PrEP)
• People who have a condition for which the study drug venetoclax is already an indicated treatment
• People currently taking certain antifungal or antibiotic medications, or HIV drugs, that affect how the body processes venetoclax (such as ketoconazole, voriconazole, ritonavir, cobicistat, or clarithromycin) (confirm with trial site)
• People currently taking any HIV protease inhibitor medication
• People currently taking certain medications that affect a drug-transport system in the body called P-gp (including cobicistat, ritonavir, azithromycin, and clarithromycin)
• People currently taking certain medications with a narrow safe dosage range that are affected by the same drug-transport system, such as digoxin, tacrolimus, or cyclosporine (confirm with trial site for full list)
• People currently taking strong or moderate medications that reduce venetoclax levels in the body, such as carbamazepine, phenytoin, rifampicin, St. John's wort, efavirenz, or etravirine
• People who have received immune-system-modifying treatments or chemotherapy within 28 days before joining the study
• People who are on any other treatment that the study doctors believe would make participation unsafe or affect study results
• People with a known allergy or sensitivity to venetoclax or related compounds
• People who currently have an active serious HIV-related infection (AIDS-defining opportunistic infection)
• People who plan to change their HIV treatment regimen during the study period
• People with current or recent gut or digestive conditions, or who have had gut surgery, that could affect how the study drug is absorbed
• People whose alcohol or substance use, in the study doctor's judgement, would prevent them from following the study plan reliably
• People who are unwilling or unable to follow the study procedures
• People with a history of cancer or organ transplantation, except for people who have been adequately treated for a type of skin cancer called basal cell carcinoma
• People who currently have active hepatitis B or hepatitis C infection (people whose hepatitis B or C has fully cleared are not excluded)
• People with cleared hepatitis B (isolated anti-HBcAb positive) whose HIV treatment does not include TDF or TAF
• People whose liver enzyme levels (AST or ALT) are more than three times the upper limit of the normal range
• People with severe liver disease classified as Child-Pugh Class C
• People whose kidney function is significantly reduced, with an eGFR below 50 mL/min
• People with significant heart problems
• People who are pregnant or breastfeeding
• Women of childbearing potential who are unwilling or unable to use an acceptable form of contraception as specified by the study
• People whose blood test results at screening fall outside acceptable ranges, including: platelet count at or below 100 x10⁹/L, neutrophil count at or below 1.0 x10⁹/L, haemoglobin below 10.0 g/dL, or CD4+ T cell count below 300 cells per microlitre

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