NCT06987318

A 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

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Detailed 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, participants will be enrolled sequentially into Arm A (n=20) and then Arm B (n=20). The study consists of three steps including an analytic treatment interruption. Arm A: * Step 1: Participants remain on ART and will receive an infusion of VRC07-523LS and PGT121.414.LS at study entry. * Step 2: Participants will interrupt their ART and receive a second infusion of VRC07-523LS 12 weeks after the initial infusion. Participants will be monitored closely for indications to resume ART. * Step 3: Upon meeting ART restart criteria in Step 2; participants will resume ART and be followed for up to 24 weeks. Arm B: * Step 1: Participants remain on ART and will receive an infusion of VRC07-523LS and PGT121.414.LS at study entry and a second infusion of VRC07-523LS 12 weeks later. * Step 2: Participants will interrupt their ART. Participants will be monitored closely for indications to resume ART. * Step 3: Upon meeting ART restart criteria in Step 2; participants will resume ART and be followed for up to 24 weeks. Participation in both arms will last up to 98 weeks.

Conditions

• HIV-1-infection

Interventions

Type	Name	Description
BIOLOGICAL	VRC07-523LS	Administered by Intravenous (IV) infusion at Week 0 and 12 weeks later
BIOLOGICAL	PGT121.414.LS	Administered by IV infusion at Week 0

Timeline

• Start date: 2026-06-12
• Primary completion: 2027-08-29
• Completion: 2028-05-07
• First posted: 2025-05-23
• Last updated: 2026-04-03

Locations

13 sites across 3 countries: United States, Brazil, Peru

Regulatory

• FDA-regulated drug study