Testing Lenacapavir to Reduce HIV Reservoirs in Adults with Suppressed HIV on Antiretroviral Therapy

What this Trial Is About

Researchers are investigating the effects of adding lenacapavir Sunlenca to the existing antiretroviral therapy ART in people living with HIV who have had their virus suppressed for more than three years. The goal is to understand how lenacapavir affects the size of the HIV reservoirs, which are infected cells where the virus can persist even with effective ART. This study is a Phase 1 interventional trial focusing on the basic science of HIV persistence and treatment intensification. Participants will be randomly assigned to one of two groups two-thirds will receive lenacapavir in addition to their current ART, while the others will continue their ART alone. Those receiving lenacapavir will get the drug as a subcutaneous injection at the start of the study and again at 24 and 48 weeks, plus oral doses on the first two days. All participants will maintain their usual ART regimen throughout the study. The study includes up to six leukapheresis procedures where blood is filtered to collect white blood cells for analysis. During the two-year study, participants will attend 13 clinic visits for physical exams, blood tests, and leukapheresis at specified intervals. Researchers will measure changes in the size of the HIV reservoirs in CD4 T cells using a specialized assay and will also assess residual virus levels in the blood. Additional tests will explore immune cell changes and biomarkers of inflammation. The study monitors participants closely to evaluate the impact of lenacapavir intensification alongside standard ART treatment.

Lenacapavir Intensification to Disrupt HIV Reservoirs in Virologically Suppressed People With HIV Receiving Antiretroviral Therapy