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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
StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Mar 1, 2026 → Mar 1, 2027
See other at-risk trials from University of Aarhus

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Mar 1, 2026 to Mar 1, 2027 Show 5 more changesShow less
    • Study completion pushed from Dec 1, 2026 to Dec 1, 2027
    • Study sites: 1 to 2
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: details revised at 1 of 2 entries
    • Study description revised
  2. Primary completion date: Mar 1, 2025 to Mar 1, 2026
    • Study completion date: Mar 1, 2026 to Dec 1, 2026
    • Study arms: 2 to 1
    v6
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 1, 2024 to Apr 1, 2024
    • Site details revised
    v5
  4. Start date: Sep 1, 2023 to Mar 1, 2024
    • Primary completion date: Nov 1, 2024 to Mar 1, 2025
    • Study completion date: Mar 1, 2025 to Mar 1, 2026
    v4
  5. Primary completion date: Mar 1, 2024 to Nov 1, 2024
    • Start date: Feb 1, 2023 to Sep 1, 2023
    • Study completion date: Oct 1, 2024 to Mar 1, 2025
    v3
  6. Secondary endpoints: details revised at 1 of 2 entriesv2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
(from sponsor)		 HIV-1-infection
Enrollment 18 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov