drugset / Trial / NCT05668026
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
Phase 1/2
Recruiting
18 enrolled
University of Aarhus
Aarhus University Hospital · collabThe Alfred · collabThe Peter Doherty Institute for Infection and Immunity · collabWalter and Eliza Hall Institute of Medical Research · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2024-04-01
- Primary completion
- 2026-03-01
- Completion
- 2026-12-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Venetoclax | Small molecule | 200 mg | — |
| Subject | Venetoclax | Small molecule | 400 mg | — |
| Subject | Venetoclax | Small molecule | 800 mg | — |