Randomized Phase II Trial of ART with Dual Long-acting HIV-specific Broadly Neutralising Antibodies or Placebo in Adults with Early Treated HIV Infection to Control Virus Without ART

What this Trial Is About

Researchers are evaluating the use of dual long-acting broadly neutralising antibodies bNAbs, 3BNC117-LS and 10-1074-LS, in adults living with HIV who started antiretroviral therapy ART early during primary HIV infection. This phase II randomized, placebo-controlled, double-blinded trial aims to determine whether these antibodies can control HIV replication when ART is paused. The study includes adults aged 18 to 60 years who have been on suppressive ART for at least 12 months. Participants will be randomly assigned to one of two groups one receiving ART plus infusions of the dual long-acting bNAbs followed by a monitored interruption of ART, and the other receiving ART plus placebo infusions followed by ART interruption. Those in the placebo group will later receive the bNAbs and undergo a second interruption of ART. The study will monitor the time to viral rebound after stopping ART, with treatment resumption and further monitoring as needed. During the study, participants will attend regular visits for blood sampling, assessments, and close monitoring of viral load to detect HIV rebound. Researchers will evaluate how long it takes for the virus to return after stopping ART, up to 20 weeks. Participants must comply with study procedures, including follow-up visits and blood tests, and will be monitored for safety throughout the study, which continues until viral rebound or study completion.

A Randomised Placebo Controlled Trial of ART Plus Dual Long-acting HIV-specific Broadly Neutralising Antibodies (bNAbs).