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A Clinical Trial of Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined With ART Initiation During Acute HIV Infection to Induce HIV Remission
NCT05719441 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- OTHER Placebo
- BIOLOGICAL VRC07-523LS
- BIOLOGICAL PGT121.414.LS
- DRUG ART
Study Locations (20)
California
- 1201, University of Southern California CRS — Los Angeles
- 601, University of California, Los Angeles CARE Center CRS — Los Angeles
- 701, UCSD Antiviral Research Center CRS — San Diego
- 801, University of California, San Francisco HIV/AIDS CRS — San Francisco
- 603, Harbor University of California Los Angeles Center CRS — Torrance
New York
- 7804, Weill Cornell Chelsea CRS — New York
- 30329, Columbia Physicians & Surgeons (P&S) CRS — New York
- 7803, Weill Cornell Uptown CRS — New York
- 31787, University of Rochester Adult HIV Therapeutic Strategies Network CRS — Rochester
Illinois
- 2701, Northwestern University CRS — Chicago
- 2702, Rush University CRS — Chicago
Massachusetts
- 101, Massachusetts General Hospital CRS (MGH CRS) — Boston
- 107, Brigham and Women's Hospital Therapeutics (BWH TCRS) CRS — Boston
Alabama
- 31788, Alabama CRS — Birmingham
Colorado
- 6101, University of Colorado Hospital CRS — Aurora
District of Columbia
- 31791, Whitman-Walker Institute, Inc. CRS — Washington D.C.
Georgia
- 5802, The Ponce de Leon Center CRS — Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2024-08-19 |
| Est. Completion | 2028-09-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05719441
The ClinicalTrials.gov registry entry for NCT05719441 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Acute HIV Infection appearing as the primary indexed condition, and to 4 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05719441 reports 20 study locations spanning 11 distinct geographic areas — top geographies include California, New York, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05719441 about?
NCT05719441 is a clinical study titled "A Clinical Trial of Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined With ART Initiation During Acute HIV Infection to Induce HIV Remission". 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 a...
What is the current status of trial NCT05719441?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2024-08-19. Estimated completion is 2028-09-06.
What conditions does trial NCT05719441 study?
This clinical trial studies the following conditions: Acute HIV Infection. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05719441?
The interventions under investigation include: Placebo (OTHER), VRC07-523LS (BIOLOGICAL), PGT121.414.LS (BIOLOGICAL), ART (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05719441?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05719441 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, District of Columbia, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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