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

StatusRecruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary completion moved at least 3 months later Apr 6, 2028 → Jul 17, 2028
Primary endpoint reworded 2 of 2 changed
See other at-risk trials from National Institute of Allergy and Infectious Diseases (NIAID)

Record History

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  1. Primary endpoint(s) modified Show 5 more changesShow less
    • Primary completion pushed from Apr 6, 2028 to Jul 17, 2028
    • Trial sites reduced: 36 → 12 locations
    • Study completion pushed from Sep 6, 2028 to Jun 18, 2029
    • Eligibility criteria shortened, about 1,364 words
    • Secondary endpoints revised (13)
  2. Site details revised at 2 of 36 sitesv19
  3. Site details revised at 1 of 36 sitesv18
  4. Site details revised at 1 of 36 sitesv17
  5. Site details revised at 1 of 36 sitesv16
Show 14 earlier versionsHide 14 earlier versions
  1. Trial status: Suspended to Recruiting
    • Site details revised at 36 of 36 sites
    v15
  2. Trial status: Recruiting to Suspended Sponsor's reason: Temporarily Closed (Paused) to Accrual
    • Site details revised at 36 of 36 sites
    v14
  3. Site details revised at 1 of 36 sitesv13
  4. Site details revised at 1 of 36 sitesv12
  5. Primary completion date: Sep 6, 2025 to Apr 6, 2028v11
  6. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 30, 2024 to Aug 19, 2024
    • Site details revised at 36 of 36 sites
    v10
  7. Start date: Jun 15, 2024 to Aug 30, 2024v9
  8. Start date: Apr 30, 2024 to Jun 15, 2024v8
  9. Site contacts updated at 1 of 36 sitesv7
  10. Start date: Mar 31, 2024 to Apr 30, 2024v6
  11. Start date: Feb 1, 2024 to Mar 31, 2024v5
  12. Re-verified, no change to tracked fieldsv4
  13. Start date: Oct 25, 2023 to Feb 1, 2024v3
  14. Start date: Mar 6, 2023 to Oct 25, 2023v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05719441
Lead Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Conditions
(from sponsor)		 Acute HIV Infection
Enrollment 48 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov