NCT05719441

A Clinical Trial of Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined With ART Initiation During Acute HIV Infection to Induce HIV Remission

A Double-Blind, Randomized, Placebo-Controlled Clinical Trial of Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined With ART Initiation During Acute HIV Infection to Induce HIV Remission

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

A5388 is a phase II, two-arm, randomized, double-blind, placebo-controlled study that will enroll 48 antiretroviral therapy (ART)-naïve adults with acute HIV infection (AHI) in order to determine whether: * Administration of combination HIV-specific broadly neutralizing antibody (bNAb) therapy in addition to ART during acute HIV infection (AHI) will be safe. * Participants who receive combination bNAb therapy in addition to ART during AHI will be more likely to demonstrate a delay in time to HIV-1 RNA ≥1,000 copies/mL for 4 consecutive weeks compared to participants who receive placebo plus ART. * Participants who receive combination bNAb therapy in addition to ART during AHI will demonstrate lower viral reservoirs and enhanced HIV-specific immunity compared to participants who receive placebo plus ART.

Conditions

• Acute HIV Infection

Interventions

Type	Name	Description
BIOLOGICAL	VRC07-523LS	10 mg/kg intravenous infusion over approximately 15 to 30 minutes once at entry
BIOLOGICAL	PGT121.414.LS	5 mg/kg intravenous infusion over approximately 30 to 60 minutes once at entry
OTHER	Placebo	Sodium Chloride for Injection USP, 0.9%
DRUG	ART	Bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablet orally once daily with or without food

Timeline

• Start date: 2024-08-19
• Primary completion: 2028-04-06
• Completion: 2028-09-06
• First posted: 2023-02-09
• Last updated: 2025-11-18

Locations

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

Regulatory

• FDA-regulated drug study