Actively Recruiting
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
Led by University of Aarhus · Updated on 2025-04-01
18
Participants Needed
1
Research Sites
139 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
In summary, there is a compelling rationale for investigating venetoclax as an intervention to sensitise virus-expressing cells to apoptosis and thereby reduce the size of the latent HIV reservoir. While this concept may ultimately need to be tested in the setting of concomitant latency reversal, the investigators propose to initially establish the safety of venetoclax in PLWH on ART. The investigators will use this study to also investigate effects of venetoclax monotherapy on proapoptotic pathways, immune effector function and HIV persistence in PLWH on ART and through these studies establish the rationale for subsequent studies testing venetoclax in combination with an LRA.
CONDITIONS
Official 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 inclusive
- Receiving combination ART for at least 2 years and on the same ART regimen for at least 4 weeks at screening
- HIV-1 plasma RNA below 50 copies/mL for over 2 years with at least two documented occasions and below 20 copies/mL at screening
- CD4+ T cell count above 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 throughout the study
- For those receiving a SARS-CoV-2 vaccine during the study, therapy will start 4 weeks after vaccination completion
- Female participants must be either non-child-bearing or use effective contraception and have negative pregnancy tests at screening and Day 1
- All participants must agree to avoid conception during the study
- Heterosexually active males must use effective contraception or be sterile as confirmed before study entry
You will not qualify if you...
- Current or prior use of BCL-2 antagonists or pro-apoptotic cancer therapies
- Any disease requiring venetoclax treatment
- Current use of moderate or strong CYP3A4 inhibitors or HIV protease inhibitors
- Current use of strong inhibitors of the P-gp drug efflux pump except allowed drugs with dosing adjustments
- Current use of strong or moderate CYP3A4 inducers, with avoidance recommended
- Recent use (within 28 days) of immunomodulating or systemic chemotherapy agents
- Any therapy or condition judged by investigators to affect study suitability or results
- Known allergies to venetoclax or related compounds
- Significant acute illness in past 4 weeks
- Active AIDS-defining opportunistic infection
- Planned ART regimen changes during the study
- Recent gastrointestinal disease or surgery affecting drug absorption
- Active substance or alcohol use impairing compliance
- Inability or unwillingness to follow study procedures
- History of malignancy or transplantation except treated basal cell carcinoma
- Hepatitis B or C co-infection except cleared hepatitis C
- Liver impairment with AST or ALT greater than 3 times normal
- Severe liver impairment (Child-Pugh Class C)
- Renal impairment with eGFR below 50 mL/min
- Significant cardiac dysfunction
- Pregnancy, breastfeeding, or unwillingness to use contraception as specified
- Abnormal lab values at screening including low platelet, neutrophil, hemoglobin, lymphocyte, or CD4+ counts or impaired kidney/liver function
AI-Screening
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Trial Site Locations
Total: 1 location
1
Aarhus University Hospital
Aarhus, Denmark
Actively Recruiting
Research Team
J
Jesper D Gunst
CONTACT
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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