Clinical Trial

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

Study acronym: AMBER
Recruiting Phase 1/2
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Record status
This record was last updated April 1, 2025 (before its estimated March 1, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2022-12-19; most recent amendment 2025-03-26.
Status change: Not Yet Recruiting → Recruiting 2024-04-16
Trial Details
NCT Number NCT05668026
Lead Sponsor University of Aarhus
Collaborators: The Peter Doherty Institute for Infection and Immunity, Walter and Eliza Hall Institute of Medical Research, The Alfred, Aarhus University Hospital
Conditions HIV-1-infection
Enrollment 18 participants
Start Date 2024-04-01
Primary Completion 2026-03-01 (estimated)
Study Completion 2026-12-01 (estimated)
Updated on ClinicalTrials.gov 2025-04-01