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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

RecruitingPhase 2Ages 18 Years - 70 YearsAllNational Institute of Allergy and Infectious Dise…
NCT05719441 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 during an Analytical Treatment Interruption (ATI) 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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

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📋 Eligibility rules (as published)
* Between 18 and 70 years of age * Body weight under 115 kg (approximately 253 pounds) * Evidence of recently acquiring HIV * Not pregnant or breastfeeding * No recent use of medications to prevent or treat HIV * Able and willing to provide informed consent to study and its procedures which include * initiating HIV medications (also called antiretroviral treatment or ART) following enrollment, * A later, monitored pause in HIV medications (also called an analytical treatment interruption, or ATI) * While pausing HIV treatment per study guidelines until resuppressed following treatment restart, agree to using barrier contraception to prevent HIV acquisition in sexual partners * Agree to use effective contraception to prevent pregnancy in oneself and sexual partners who may become pregnant.
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What it tests

  • VRC07-523LS
  • PGT121.414.LS
  • Placebo
  • ART
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Where

12 sites
31788, Alabama CRS
Birmingham, United States
6101, University of Colorado Hospital CRS
Aurora, United States
5802, The Ponce de Leon Center CRS
Atlanta, United States
2701, Northwestern University CRS
Chicago, United States
31786, New Jersey Medical School Clinical Research Center CRS
Newark, United States
2301, Ohio State University CRS
Columbus, United States
6201, Penn Therapeutics CRS
Philadelphia, United States
31473, Houston Advancing Research Team CRS
Houston, United States

…and 4 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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