Study of Two Long-Acting HIV Antibodies Combined With Antiretroviral Therapy in Adults Living With HIV-1 in Sub-Saharan Africa

What this Trial Is About

Researchers are evaluating two new laboratory-made antibodies, 10-1074-LS and 3BNC117-LS, for adults living with HIV-1 in Sub-Saharan Africa. These antibodies are designed to attach to HIV and block it from infecting cells and spreading. The study aims to see if these antibodies affect the amount of HIV that remains in blood cells while on antiretroviral therapy ART and after stopping ART, as well as to assess their safety and any side effects. Participants will be randomly assigned to receive either the two antibodies or placebo infusions combined with ART at the start of the study. The antibodies and placebos are given intravenously on the first day of the initial treatment period. The study includes multiple steps, including starting ART with antibody or placebo infusions, stopping ART under close monitoring, and following participants to observe the return of the virus and any need to restart ART. During the study, participants will attend scheduled visits for blood tests to measure HIV levels, immune cell counts, and safety labs. Researchers will track side effects and monitor how long it takes for the virus to rebound after stopping ART. Participants will also be asked to use contraception methods if of child-bearing potential and follow precautions to prevent HIV transmission during treatment interruption. The study duration includes at least 56 weeks of safety and efficacy monitoring after infusion and follow-up for up to 72 weeks after ART discontinuation.

Antiretrovirals Combined With Antibodies for HIV-1 Cure In Africa