Comparing Twice-Yearly Lenacapavir, Teropavimab, and Zinlirvimab Injections to Every 8-Week Cabotegravir and Rilpivirine Injections in Adults With Well-Controlled HIV-1 on Oral Therapy

What this Trial Is About

This clinical trial investigates the effectiveness of two different long-acting injectable HIV treatments in adults with well-controlled HIV-1 on daily oral therapy. The study compares a regimen of lenacapavir LEN, teropavimab TAB, and zinlirvimab ZAB given twice a year to cabotegravir CAB and rilpivirine RPV injections given every 8 weeks. The main goal is to evaluate how well these treatments keep the virus suppressed after one year of use. Participants are randomly assigned to one of two treatment groups. One group receives oral LEN and subcutaneous LEN, along with intravenous infusions of TAB and ZAB initially and then every 26 weeks up to 92 weeks. The other group stops their current oral therapy and starts intramuscular injections of CAB and RPV on Day 1, Week 4, and every 8 weeks thereafter for up to 92 weeks. After Week 92, eligible participants may continue LEN, TAB, and ZAB in an extension phase until completion or discontinuation. During the study, participants undergo regular monitoring including HIV-1 RNA measurements to track viral load, CD4 T-cell counts, and assessments for treatment-related adverse events. Researchers will measure the proportion of participants with HIV-1 RNA levels of 50 copiesmL or higher at Week 52 as the primary outcome. Safety and drug concentration levels are also evaluated throughout the study, which may last up to several years including the extension phase.

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