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:

• People who have a confirmed HIV-1 diagnosis.
• People aged between 18 and 65 years (inclusive).
• People who have been on combination HIV treatment (ART) for at least 2 years, and on the same treatment regimen for at least 4 weeks before the screening visit.
• People whose HIV levels in the blood have been below 50 copies/mL for more than 2 years (recorded on at least 2 occasions), and below 20 copies/mL at the time of screening. A single blip between 50–500 copies/mL is allowed if the next test result came back below 50 copies/mL.
• People whose CD4+ immune cell count (a measure of immune system health) is above 500 cells/µL at screening, and has been above that level on at least two occasions in the past 24 months.
• People who are willing and able to give informed consent and to continue their HIV treatment throughout the study.
• People who plan to receive a COVID-19 vaccine during the study period may still be considered, but the start of the study treatment would be delayed until 4 weeks after completing COVID-19 vaccination (screening can begin before or during vaccination).
• Women who cannot become pregnant, defined as being post-menopausal (at least 45 years old with 12 months of no periods) or having had a tubal ligation, hysterectomy, or removal of both ovaries.
• Women who could become pregnant, provided they have a negative pregnancy test at screening and on Day 1, and agree to use a highly effective method of contraception (with a failure rate of less than 1% per year) consistently throughout the study and for at least 2 weeks after the study treatment ends. Accepted methods include complete abstinence from penile-vaginal intercourse, a qualifying intrauterine device (IUD), a partner who has had a confirmed vasectomy, approved hormonal contraception (noting that some study medications may reduce how well hormonal contraception works, in which case non-hormonal methods are recommended), or any other method with published data showing less than 1% yearly failure.
• All participants must agree not to try to conceive a child during the study (including through sperm donation, IVF, or egg donation).
• Heterosexually active male participants must agree to use an effective contraception method — either confirmed anatomical sterility in themselves, or their partner using a method with less than 1% yearly failure rate (such as hormonal contraception, an IUD, or confirmed anatomical sterility) — from the day before the first dose until at least 2 weeks after the last dose.

Who may not be able to join:

• People who currently use or have previously used a BCL-2 antagonist or similar pro-cell-death cancer therapy (such as venetoclax used for cancer treatment).
• People who have a condition for which venetoclax (the study drug) is already an approved treatment.
• People currently taking certain medications that strongly affect how the body processes drugs, including specific antifungals, some HIV medications (such as ritonavir or cobicistat), or clarithromycin (confirm with trial site for full list).
• People currently taking any HIV protease inhibitor medication.
• People currently taking strong inhibitors of a drug transporter called P-gp (including cobicistat, ritonavir, azithromycin, and clarithromycin).
• People currently taking strong medications that speed up drug breakdown in the body (such as carbamazepine, phenytoin, rifampicin, or St. John's Wort); certain moderate versions of these (such as efavirenz or etravirine) may be allowed but are to be avoided where possible.
• People who have received immune-modifying or chemotherapy agents within the 28 days before joining the study.
• People currently on any other treatment that the study investigators believe would make participation unsafe or affect the study results.
• People with a known allergy or sensitivity to venetoclax or related compounds.
• People who have had a significant acute illness in the past 4 weeks.
• People who have an active AIDS-defining opportunistic infection.
• People who plan to change their HIV treatment regimen during the study period.
• People with current or recent gut or gastrointestinal conditions or surgery that could affect how the study drug is absorbed.
• People with active alcohol or substance use that the investigator believes would prevent them from following the study requirements.
• People who are unwilling or unable to follow the study procedures.
• People with a history of cancer or organ transplantation, except those who have been adequately treated for basal cell skin cancer.
• People who also have hepatitis B or hepatitis C infection (people who previously had hepatitis C but have since cleared the infection may still be considered eligible).
• People with liver function test results (AST or ALT) more than 3 times the upper limit of the normal range.
• People with severe liver disease classified as Child-Pugh Class C.
• People with reduced kidney function, with an estimated filtration rate (eGFR) below 50 mL/min.
• People with significant heart problems.
• Women who are pregnant or breastfeeding, or women who could become pregnant but are unwilling or unable to use an acceptable contraception method as outlined in the inclusion criteria.
• People whose blood test results at screening fall outside acceptable ranges, specifically: liver enzymes (AST or ALT) at 3 or more times the normal upper limit; eGFR below 50 mL/min; platelet count at or below 100 x10⁹/L; neutrophil count at or below 1.5 x10⁹/L; haemoglobin below 10.0 g/dL; total lymphocyte count below 800 cells/µL; or CD4+ cell count below 500 cells/µL.

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