National Institute of Allergy and Infectious Diseases (NIAID)
The purpose of this study is to evaluate the safety, tolerability, and efficacy of combination broadly neutralizing antibodies (bNAbs), to induce HIV-1 control during analytic treatment interruption (ATI).
This study is an open-label, two-arm, multi-step phase I study evaluating a combination of two broadly neutralizing antibodies (bNAbs), VRC07-523LS and PGT121.414.LS, in people living with HIV (PWH) who started antiretroviral therapy (ART) during acute/early infection. Participants will receive PGT121.414.LS and VRC07-523LS prior to undergoing an analytical treatment interruption (ATI). Participants will restart ART and continue follow-up after ATI to confirm viral suppression. Participants will be screened for eligibility and have a pre-entry visit. After determination of eligibility, partic…
Inclusion Criteria: * Ability and willingness of participant to provide informed consent. * Initiation of combination ART within 90 days of acute HIV diagnosis as defined by any of the criteria listed below: * A negative HIV Ab or HIV Ag/Ab Combination Assay and a detectable HIV-1 RNA (qualitative or quantitative) or a subsequently positive Western blot (WB) or equivalent HIV-1 confirmatory assay (e.g. Geenius assay) if no positive HIV-1 RNA test was available. * A positive HIV Ab or HIV Ag/Ab Combination Assay or p24 antigen test and a negative or indeterminate HIV confirmatory/differen…
Administered by Intravenous (IV) infusion at Week 0 and 12 weeks later
Administered by IV infusion at Week 0