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Study of Lenacapavir, Teropavimab, and Zinlirvimab in Virologically Suppressed Adults With HIV-1 on Stable Oral Treatment Regimens

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

Amendment history

2026-07-29
notable
Study Status, Contacts/Locations, References v1
Recruitment opened
Start dateestimated 2026-07→confirmed 2026-07-14
Study sites0→2
2026-06-26
minor
Original filing
107 trials monitored
See 8 trials at risk
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.
Trial Details
NCT Number NCT07683000
Lead Sponsor Gilead Sciences
Conditions HIV-1-infection
Enrollment 590 participants
Start Date 2026-07-14
Primary Completion 2029-03 (estimated)
Study Completion 2033-03 (estimated)
Updated on ClinicalTrials.gov 2026-07-30