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NCT05719441 · ClinicalTrials.gov registry record · Phase 2
A Clinical Trial of Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined With ART Initiation During Acute HIV Infection to Induce HIV Remission
A Phase 2 study of Acute HIV Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
- 20
- Study locations
NCT05719441: Recruiting Phase 2 study of Acute HIV Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT05719441 is a Phase 2 study of Acute HIV Infection that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 48 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05719441, a Phase 2 study of Acute HIV Infection, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
- 20
- Study locations
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 |
What NCT05719441 shows while recruiting
NCT05719441 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower).
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.
NCT05719441 names 20 study sites across 11 states, led by California, New York, Illinois.
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.
What interventions are being tested in trial NCT05719441?
The interventions under investigation include: Placebo (OTHER), VRC07-523LS (BIOLOGICAL), PGT121.414.LS (BIOLOGICAL), ART (DRUG).
Who is sponsoring clinical trial NCT05719441?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05719441's enrollment target sits among peer trials
48 1265th of 2000 higher than 719 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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