Comparing Twice-Yearly Injectable Lenacapavir, Teropavimab, and Zinlirvimab with Daily Oral HIV Treatment in Adults with Controlled HIV-1

What this Trial Is About

Researchers are evaluating how well a long-acting injectable combination treatment of lenacapavir, teropavimab, and zinlirvimab works compared to continuing daily oral HIV treatment in adults with HIV-1 who already have their virus well controlled. The study focuses on virologically suppressed people with HIV-1 and aims to measure how many participants maintain viral suppression after one year of treatment. Participants in one group will receive an initial dose of oral and injectable lenacapavir along with intravenous infusions of teropavimab and zinlirvimab on Day 1, followed by self-administered oral lenacapavir on Day 2. Every 26 weeks, they will receive additional injections and infusions up to Week 92, with an option to continue in an extension phase. The other group will continue their stable oral antiretroviral therapy as prescribed, also with an option to switch to the injectable combination after Week 92. Throughout the study, participants will be monitored for viral load levels at Weeks 52 and 92 using FDA-approved methods, changes in CD4 T-cell counts, and the presence of antibodies against study drugs. Safety will be assessed by tracking adverse events and treatment discontinuations. Drug levels will also be measured at several timepoints. The study may last until March 2033, including the extension phase for those who continue treatment.

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