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

Conditions

• Acute HIV Infection

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Aug 19, 2024

Status verified

Apr 2026

Primary completion

Apr 6, 2028

Completion

Sep 6, 2028

Study Design

Enrollment

48 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm 1: VRC07-523LS + PGT121.414.LS + ART
• Placebo Comparator: Arm 2: Placebo + ART

Primary Outcome Measure

Occurrence of Grade ≥2 AE or SAE that are possibly, probably, or definitely related to the study bNAbs during Step 1 [ Time Frame: Week 0 to end of Step 1 ]

Locations (32)

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