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Phase II Trial of ART + Dual bNAbs vs. ART + Placebo During Primary HIV-1 Infection-impact on Post-ART Control

Study acronym: RHIVIERA-02
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Site details revised at 15 of 17 sitesv8
  2. Trial status: Not Yet Recruiting to Recruitingv7 Show 4 more changesShow less
    • Primary completion date: Dec 2026 to Dec 10, 2026
    • Study completion date: Dec 2028 to Dec 10, 2028
    • Start date changed from estimate of Apr 15, 2024 to Apr 11, 2024
    • Site details revised at 17 of 17 sites
  3. Start date: Jan 15, 2024 to Apr 15, 2024
    • Site contacts updated at 7 of 17 sites
    v6
  4. Start date: Oct 15, 2023 to Jan 15, 2024v5
  5. Start date: May 15, 2023 to Oct 15, 2023
    • Enrollment target: 60 to 69
    • Eligibility criteria shortened, about 8 words
    • Study description revised
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Start date: Dec 2022 to May 15, 2023v3
  2. Primary completion date: Feb 2026 to Dec 2026
    • Start date: Apr 2022 to Dec 2022
    • Study completion date: Feb 2028 to Dec 2028
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
RHIVIERA-02 trial is a placebo-controlled double-blinded two arm prospective phase II trial. This study will test the use of broadly neutralising antibodies (bNAbs) in participants, at primary HIV infection (PHI) and ART initiation.
Trial Details
NCT Number NCT05300035
Lead Sponsor ANRS, Emerging Infectious Diseases
Collaborators: Rockefeller University, Institut Pasteur
Conditions
(from sponsor)		 HIV/AIDS and Infections
Related terms Acquired Immunodeficiency Syndrome, Infections
Enrollment 69 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov