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

StatusRecruiting
PhasePhase 3
Started2026-07-14
View on ClinicalTrials.gov ↗

Amendment history

2026-08-13
Study Status, Contacts/Locations v2
Trial sites expanded: 3 → 19 locations
2026-07-20
Study Status, Contacts/Locations, References v1
Recruitment opened
Trial sites expanded: 0 → 3 locations
Start dateestimated 2026-07→confirmed 2026-07-14
2026-06-26
Original filing
Gilead Sciences
107 trials monitored
See 8 trials at risk
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.
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