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

Sponsor
University of Aarhus
Study ID
NCT05668026
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • HIV-1-infection

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Venetoclax — DRUG
    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.

Study Details

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.

Key Dates

Start date
Apr 1, 2024
Status verified
Apr 2024
Primary completion
Mar 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single-arm
    Study participants will receive venetoclax daily for 14 days followed by 21 days off defined as one cycle. This dosing will then be repeated for two additional cycles.

Primary Outcome Measure

To determine the safety of venetoclax in PLWH on ART [ Time Frame: 0-140 days ]

Central Contacts

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