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Inhibiting BCL-2 at the start of HIV treatment to reduce the HIV reservoir in people living with HIV
EU CTIS ID: 2025-521841-26-00
What this study is testing
To determine the safety of venetoclax administration in PLWH at the time of ART initiation
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Documented HIV-1 infection
- All participants must agree to use condoms during all sexual intercourse in situations where HIV transmission may still occur, i.e. until fully suppressed on ART (plasma HIV-1 RNA <50 copies/mL)
- Age 18-70 years (both included) at screening
- CD4+ T cell count >300/µL at screening
- ART naïve at screening
- Able to give informed consent
You likely can't join if
- Current or previous use of a BCL-2 antagonist or other pro-apoptotic agent used as cancer therapy
- Any other current or prior therapy which, in the opinion of the investigators, would make the individual unsuitable for the study or influence the results of the study
- Known hypersensitivity to the components of venetoclax or its analogues
- Any evidence of an active AIDS-defining opportunistic infection
- Individuals who intend to modify their ART regimen within the study period
- Current or recent gastrointestinal disease or gastrointestinal surgery that may impact the absorption of the investigational drug
See the full eligibility criteria
Who can join
- Documented HIV-1 infection
- All participants must agree to use condoms during all sexual intercourse in situations where HIV transmission may still occur, i.e. until fully suppressed on ART (plasma HIV-1 RNA <50 copies/mL)
- Age 18-70 years (both included) at screening
- CD4+ T cell count >300/µL at screening
- ART naïve at screening
- Able to give informed consent
- Ability and willingness to provide informed consent and to continue ART throughout the study
- A female, may be eligible to enter and participate in the study if she: - Is of non-child-bearing potential defined as either post-menopausal (12 months of spontaneous amenorrhea and ≥ 45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy or, - Is of child-bearing potential with a negative pregnancy test at both Screening and Day 1 and agrees to use one of the following methods of contraception to avoid pregnancy: Complete abstinence from penile-vaginal intercourse from 2 weeks prior to administration of IP, throughout the study, and for at least 4 weeks after discontinuation of all study medications Any intrauterine device (IUD) with published data showing that the expected failure rate is <1% per year Male partner sterilization confirmed prior to the female subject’s entry into the study, and this male is the sole partner for that subject Approved hormonal contraception (Where other medications to be used in the study (e.g., efavirenz and darunavir) are known, or are likely, to significantly interact with systemic contraceptives, resulting in decreased efficacy of the contraceptive, then alternative methods of non-hormonal contraception are recommended) Any other method with published data showing that the expected failure rate is <1% per year Any contraception method must be used consistently, in accordance with the approved product label and for at least 4 weeks after discontinuation of study therapy.
- All participants must agree not to participate in a conception process (e.g. active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization, egg donation) during the study
- Heterosexually active male if they are - willing to use an effective method of contraception (anatomical sterility in self that is confirmed prior to study entry) or - agree on the use of an effective method of contraception with an effective failure rate of < 1% by his partner (hormonal contraception, intra-uterine device (IUD), or anatomical sterility) from the day prior to the first dose and for at least 4 weeks after discontinuation of study drug.
What rules you out
- Current or previous use of a BCL-2 antagonist or other pro-apoptotic agent used as cancer therapy
- Any other current or prior therapy which, in the opinion of the investigators, would make the individual unsuitable for the study or influence the results of the study
- Known hypersensitivity to the components of venetoclax or its analogues
- Any evidence of an active AIDS-defining opportunistic infection
- Individuals who intend to modify their ART regimen within the study period
- Current or recent gastrointestinal disease or gastrointestinal surgery that may impact the absorption of the investigational drug
- Active alcohol or substance use that, in the Investigator's opinion, will prevent adequate compliance with study therapy or procedures
- Unable or unwilling to adhere to protocol procedures
- History of malignancy or transplantation, excluding adequately treated basal cell carcinoma
- Co-infection with hepatitis B defined as HBsAg-positive or Hepatitis C defined as HCV-RNA positive (Individuals with prior hepatitis B or C infection that is now cleared are eligible for enrolment); For individuals with isolated anti-HBcAb (cleared hepatitis B), the chosen ART regimen must include TDF or TAF
- Impaired liver function with AST or ALT >3 times upper limit of normal
- Evidence of or strong suspicion that HIV infection was acquired during active PrEP use
- Severe hepatic impairment (Class C) as determined by Child-Pugh classification
- Impaired renal function with estimated creatinine clearance (eGFR) <50 mL/min
- Significant cardiac dysfunction
- Women who are pregnant or breastfeeding or Women of Child Bearing Potential (WOCBP) who are unwilling or unable to use an acceptable method of contraception to avoid pregnancy as specified in the inclusion criteria
- The following laboratory values at screening (lab tests may be repeated, as clinically indicated, to obtain acceptable values before failure at screening is concluded but supportive therapies are not to be administered within the week prior to screening tests): - Platelet count ≤100 x109/L - Absolute neutrophil count ≤1.0x109/L - Haemoglobin <10,0 g/dL - CD4+ T cell count <300 cells/uL
- Any concomitant disease where venetoclax treatment is indicated
- Current use of any moderate or strong CYP3A4 inhibitors (such as ketoconazole, voriconazole, posaconazole, itraconazole, ritonavir, cobicistat and clarithromycin)
- Current use of any HIV protease inhibitor (due to CYP3A4 inhibition)
- Current use of any strong inhibitor of the P-gp drug efflux pump (this includes cobicistat, ritonavir, azithromycin and clarithromycin)
- Current use of P-gp substrates with narrow therapeutic index (such as such as digoxin, tacrolimus, cyclosporine, sirolimus, dabigatran, colchicine, loperamide)
- Current use of strong or moderate CYP3A4 inducers (such as carbamazepine, phenytoin, rifampicin, St. John’s wort, bosentan, efavirenz and etravirine); intermittent use of moderate CYP3A4 inducers such as modafinil and nafcillin may be used but should be avoided as much as possible
- Receipt of immunomodulating agents (excluding immunisation) or systemic chemotherapeutic agents within 28 days prior to study entry
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.