Clinical Trial

Study of Lenacapavir, Teropavimab, and Zinlirvimab Versus Cabotegravir and Rilpivirine in Virologically Suppressed Adults With HIV-1 on Oral Daily Antiretroviral Therapy

Recruiting Phase 3
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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.
Protocol Amendment History 3 changes
notable Trial sites expanded: 3 -> 19 locations 2026-08-15
critical Recruitment opened 2026-07-23
notable Trial sites expanded: 0 -> 3 locations 2026-07-23
Trial Details
NCT Number NCT07682961
Lead Sponsor Gilead Sciences
Conditions HIV Infections
Enrollment 590 participants
Start Date 2026-07-14
Primary Completion 2029-03 (estimated)
Study Completion 2033-03 (estimated)
Updated on ClinicalTrials.gov 2026-08-14