Phase II Randomized Trial of Dual Long-acting Broadly Neutralizing Antibodies Plus ART Versus ART Plus Placebo in Adults With Primary HIV-1 Infection to Study Post-Treatment HIV Control

What this Trial Is About

Researchers are evaluating the use of dual long-acting broadly neutralizing antibodies bNAbs combined with antiretroviral therapy ART in people diagnosed with primary HIV-1 infection. This phase II, placebo-controlled, randomized trial compares ART plus dual bNAbs to ART plus a placebo to study how these treatments affect HIV-1 control after stopping ART. The trial is conducted in French clinical centers and sponsored by ANRS, Emerging Infectious Diseases. Participants receive either ART with dual intravenous infusions of the bNAbs 3BNC117-LS and 10-1074-LS or ART with placebo infusions. Infusions start between days 7 and 10 after diagnosis, followed by at least 52 weeks of ART. After this period, participants undergo an analytical treatment interruption ATI where ART is stopped under close monitoring to observe viral rebound. Throughout the study, participants will have regular monitoring of HIV-1 RNA levels, CD4 counts, immune responses, and safety assessments up to 148 weeks. Researchers will track the proportion of participants maintaining low viral load 24 weeks after stopping ART, time to ART resumption, and any adverse events. The study duration varies per participant based on ART interruption timing and viral rebound, with detailed follow-up during and after the ATI period.

Phase II Trial of ART + Dual bNAbs vs. ART + Placebo During Primary HIV-1 Infection-impact on Post-ART Control