drugset / Trial / NCT07682961
Study of Lenacapavir, Teropavimab, and Zinlirvimab Versus Cabotegravir and Rilpivirine in Virologically Suppressed Adults With HIV-1 on Oral Daily Antiretroviral Therapy
RandomizedParallel-groupOpen-labelTreatment
Summary
The goal of this clinical study is to compare how effective a long-acting injectable treatment of lenacapavir (LEN), teropavimab (TAB), and zinlirvimab (ZAB) versus (CAB) and rilpivirine (RPV) injections given every 8 weeks in adults with HIV-1 whose virus is well controlled on daily oral treatment, after 1 year (52 weeks) of the treatment. The primary objective of this study are to evaluate the efficacy of switching to the regimen of LEN, TAB, and ZAB versus switching to CAB and RPV 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 |
|---|---|---|---|---|
| Comparator | Cabotegravir | Small molecule | 600 mg | Intramuscular |
| Subject | Lenacapavir | Small molecule | 600 mg | Subcutaneous |
| Subject | Lenacapavir | Small molecule | 927 mg | Subcutaneous |
| Comparator | Rilpivirine | Small molecule | 900 mg | Intramuscular |
| Subject | Teropavimab | Monoclonal antibody | — | Intravenous |
| Subject | Zinlirvimab | Monoclonal antibody | — | Intravenous |