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Study identifier: NCT05719441 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Acute HIV Infection  ·  Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

PhasePhase 2
Planned participants48
Who can joinAll sexes, 18 Years to 70 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Contact details are listed per location below or on the registry record.

Always discuss trial participation with your own doctor first.

Locations (36)

31788, Alabama CRSBirmingham, Alabama, United StatesNot Yet Recruiting
1201, University of Southern California CRSLos Angeles, California, United StatesNot Yet Recruiting
601, University of California, Los Angeles CARE Center CRSLos Angeles, California, United StatesNot Yet Recruiting
701, UCSD Antiviral Research Center CRSSan Diego, California, United StatesNot Yet Recruiting
801, University of California, San Francisco HIV/AIDS CRSSan Francisco, California, United StatesNot Yet Recruiting
603, Harbor University of California Los Angeles Center CRSTorrance, California, United StatesNot Yet Recruiting
6101, University of Colorado Hospital CRSAurora, Colorado, United StatesRecruiting
31791, Whitman-Walker Institute, Inc. CRSWashington D.C., District of Columbia, United StatesNot Yet Recruiting
5802, The Ponce de Leon Center CRSAtlanta, Georgia, United StatesRecruiting
2701, Northwestern University CRSChicago, Illinois, United StatesNot Yet Recruiting
2702, Rush University CRSChicago, Illinois, United StatesNot Yet Recruiting
201, Johns Hopkins University CRSBaltimore, Maryland, United StatesNot Yet Recruiting

+ 24 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT05719441