drugset / Trial / NCT07683000
Study of Lenacapavir, Teropavimab, and Zinlirvimab in Virologically Suppressed Adults With HIV-1 on Stable Oral Treatment Regimens
RandomizedParallel-groupOpen-labelTreatment
Summary
The goal of this clinical study is to compare how effective a long-acting treatment of injectable combination of lenacapavir (LEN), teropavimab (TAB), and zinlirvimab (ZAB) is versus continuing a daily oral HIV treatment in adults with HIV-1 whose virus is already well controlled, after 1 year (52 weeks) of treatment. The primary objective of this study is to evaluate the efficacy of switching to the regimen of LEN, TAB, and ZAB versus continuing an oral stable baseline regimen (SBR) in virologically suppressed people with HIV-1 (PWH) as determined by the proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 52.
Timeline
- Start
- 2026-07
- Primary completion
- 2029-03
- Completion
- 2033-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lenacapavir | Small molecule | 600 mg | Subcutaneous |
| Subject | Lenacapavir | Small molecule | 927 mg | Subcutaneous |
| Subject | Teropavimab | Monoclonal antibody | — | Intravenous |
| Subject | Zinlirvimab | Monoclonal antibody | — | Intravenous |
| Background | Dolutegravir | Other / unclassified | — | Oral |
| Background | bictegravir | Small molecule | — | Oral |
| Background | emtricitabine | Other / unclassified | — | Oral |
| Background | tenofovir alafenamide | Small molecule | — | Oral |