RecruitingPhase 1Phase 2NCT05668026

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

Administration of the BCL-2 Antagonist, Venetoclax, to Promote Apoptosis of HIV-infected Cells and Reduce the Size of the HIV Reservoir: An Investigator-initiated Phase I/IIb Clinical Trial in People Living With HIV on Antiretroviral Therapy

Sponsor

University of Aarhus

Enrollment

18 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

HIV-1-infection

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether venetoclax — a drug that causes cancer cells to self-destruct — can shrink the "reservoir" of HIV-infected cells hiding in the body of people who are already on effective HIV treatment. The goal is to explore whether this approach could bring HIV closer to being cured. **You may be eligible if...** - You are 18–65 years old and have confirmed HIV-1 infection - You have been on combination HIV treatment (ART) for at least 2 years with no recent changes - Your HIV viral load has been undetectable (under 50 copies/mL) for at least 2 years - Your CD4 immune cell count is above 500 cells/µL **You may NOT be eligible if...** - Your HIV is not well-controlled on current treatment - You have certain blood disorders, liver disease, or other serious health conditions - You are taking medications that interfere with venetoclax - You are pregnant or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVenetoclax

In this study participants will receive venetoclax 200 mg, 400 mg or 800 mg once daily for 14 days in the dose-escalation phase. In the expansion cohort, the selected max-tolerated dose will be given for three cycles, each consisting of venetoclax daily for 14 days followed by 14 days off.