Actively Recruiting
Administration of the BCL-2 Antagonist, Venetoclax, to Promote Apoptosis of HIV-infected Cells and Reduce the Size of the HIV Reservoir in People Living With HIV on Antiretroviral Therapy
Led by University of Aarhus · Updated on 2025-04-01
18
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
Sponsors
U
University of Aarhus
Lead Sponsor
T
The Peter Doherty Institute for Infection and Immunity
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of venetoclax, a BCL-2 antagonist, to promote the death of HIV-infected cells and reduce the size of the HIV reservoir in people living with HIV (PLWH) who are on antiretroviral therapy (ART). Despite ART's success in suppressing HIV replication, it cannot cure HIV due to the persistence of latent virus in certain immune cells. This study aims to assess the safety of venetoclax and its effects on pathways related to cell death, immune function, and HIV persistence, laying the groundwork for future combination studies with latency-reversing agents. Participants will receive venetoclax daily for 14 days followed by a 21-day break, with this 35-day cycle repeated three times. Initially, dose escalation will test 200 mg, 400 mg, or 800 mg once daily for 14 days. After determining the maximum tolerated dose, participants will receive three cycles of venetoclax at this dose, each cycle consisting of 14 days on treatment followed by 14 days off. This is a single-arm study without placebo, focusing on venetoclax monotherapy. During the study, participants will undergo safety monitoring and evaluations of HIV persistence and proapoptotic pathways over 140 days. They will continue their ART regimen throughout. Assessments will include laboratory tests, immune function studies, and HIV RNA measurements to understand the drug's impact. Safety will be closely observed, and participants will be followed throughout the treatment and observation periods to collect comprehensive data on venetoclax's effects in this population.
CONDITIONS
Brief Title
Administration of Venetoclax to Promote Apoptosis of HIV-infected Cells and Reduce the Size of the HIV Reservoir Among People Living With HIV on ART
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented HIV-1 infection
- Age between 18 and 65 years
- Receiving combination antiretroviral therapy for at least 2 years
- On the same ART regimen for at least 4 weeks at screening
- HIV-1 plasma RNA less than 50 copies/mL for more than 2 years and less than 20 copies/mL at screening
- CD4+ T cell count greater than 500 cells/µL at screening and at least two counts above 500 cells/µL in the prior 24 months
- Ability and willingness to provide informed consent and continue ART during the study
- For females of child-bearing potential, negative pregnancy tests at screening and Day 1 and agreement to use approved contraception
- Agreement to avoid conception during the study
- Heterosexually active males willing to use effective contraception or with sterile status
You will not qualify if you...
- Current or previous use of BCL-2 antagonists or other pro-apoptotic cancer therapies
- Any disease where venetoclax is indicated
- Use of moderate or strong CYP3A4 inhibitors or HIV protease inhibitors
- Use of strong inhibitors of the P-gp drug efflux pump
- Use of strong CYP3A4 inducers; moderate inducers to be avoided if possible
- Recent immunomodulating or systemic chemotherapy agents within 28 days prior to entry
- Known hypersensitivity to venetoclax or its components
- Significant acute illness in past 4 weeks
- Active AIDS-defining opportunistic infection
- Plans to change ART regimen during study
- Recent gastrointestinal disease or surgery affecting drug absorption
- Active alcohol or substance use impairing compliance
- History of malignancy or transplantation (except treated basal cell carcinoma)
- Co-infection with hepatitis B or C (except cleared hepatitis C)
- Impaired liver function with elevated liver enzymes or severe hepatic impairment
- Impaired renal function with eGFR below 50 mL/min
- Significant cardiac dysfunction
- Women who are pregnant, breastfeeding, or unwilling to use contraception
- Laboratory abnormalities including low platelets, neutrophils, hemoglobin, lymphocytes, or CD4+ counts as specified
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 12 weeks (3 cycles of 14 days on treatment and 21 days off)
Participants receive venetoclax daily for 14 days followed by 21 days off defined as one cycle. This dosing is repeated for a total of three cycles.
1 baseline visit and multiple visits during each cycle
Trial Site Locations
Total: 1 location
1
Aarhus University Hospital
Aarhus, Denmark
Actively Recruiting
Research Team
J
Jesper D Gunst
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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