Safety and Therapeutic Efficacy of mAb VRC01 During ATI in Early Treatment During Acute HIV Infection
Status:
Completed
Trial end date:
2019-09-01
Target enrollment:
Participant gender:
Summary
This is a placebo-controlled clinical trial of VRC01 administration and analytic treatment
interruption (ATI) in adults who began antiretroviral therapy (ART) during early acute HIV
infection (Fiebig stage I to III). Eligible volunteers will be randomized in a 3:1 ratio to
either VRC01 or placebo, with randomization stratified by Fiebig stage. Volunteers who are
receiving ART with a non-nucleoside reverse transcriptase inhibitor (NNRTI) will undergo 4
weeks of protease inhibitor (PI) substitution for their NNRTI prior to randomization. ATI
will begin the day of the first dose of either VRC01 or placebo. Participants will be
monitored closely for HIV viremia and other pre-defined criteria for ART resumption.
Administration of the study agent (VRC01) every three weeks will be discontinued after 24
weeks or if ART is resumed, whichever occurs first. Volunteers who remain virally suppressed
without laboratory or clinical indication for ART resumption at 24 weeks will continue
intensive monitoring for ART resumption criteria for an additional 24 weeks, during which
time no VRC01 or placebo will be administered.