A Phase I Study to Evaluate the Safety and Antiviral Activity of Two Human Monoclonal Antibodies (VRC07-523LS and PGT121.414.LS) During Analytic Treatment Interruption in Participants Living With HIV Who Initiated ART During Acute/Early HIV-1 Infection
National Institute of Allergy and Infectious Diseases (NIAID)
Summary
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).
Description
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…
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- BiologicalVRC07-523LS
Administered by Intravenous (IV) infusion at Week 0 and 12 weeks later
- BiologicalPGT121.414.LS
Administered by IV infusion at Week 0
Locations (13)
- Alabama CRSBirmingham, Alabama
- UCSD Antiviral Research Center CRSSan Diego, California
- University of Colorado Hospital CRSAurora, Colorado
- The Ponce de Leon Center CRSAtlanta, Georgia
- Northwestern University CRSChicago, Illinois
- Massachusetts General Hospital CRS (MGH CRS)Boston, Massachusetts