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A Randomised Placebo Controlled Trial of ART Plus Dual Long-acting HIV-specific Broadly Neutralising Antibodies (bNAbs).

Study acronym: RIO
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Dec 31, 2023 to Jul 31, 2027 Completion date: Mar 31, 2025 to Jul 31, 2027 · Site details revised at 2 of 12 sitesv7 Show 2 more changesShow less
    • Completion date: Mar 31, 2025 to Jul 31, 2027
    • Site details revised at 2 of 12 sites
  2. Primary completion date: Jun 30, 2022 to Dec 31, 2023 Primary endpoint revised · Study sites: 1 to 12 · Eligibility criteria expanded, about 138 wordsv6 Show 3 more changesShow less
    • Primary endpoint revised
    • Study sites: 1 to 12
    • Eligibility criteria expanded, about 138 words

    See this version in full on ClinicalTrials.gov ↗

  3. Trial status: Not Yet Recruiting to Recruiting Primary endpoint revised · Study sites: 0 to 1 · Start date changed from estimate of Apr 30, 2021 to May 17, 2021 · 3 morev5 Show 6 more changesShow less
    • Primary endpoint revised
    • Study sites: 0 to 1
    • Start date changed from estimate of Apr 30, 2021 to May 17, 2021
    • Eligibility criteria expanded, about 74 words
    • Secondary endpoints shortened, about 9 words
    • Study description revised

    See this version in full on ClinicalTrials.gov ↗

  4. Primary completion date: Nov 2021 to Jun 30, 2022 Start date: Jan 2021 to Apr 30, 2021 · Completion date: Oct 2024 to Mar 31, 2025v4 Show 2 more changesShow less
    • Start date: Jan 2021 to Apr 30, 2021
    • Completion date: Oct 2024 to Mar 31, 2025
  5. Start date: May 2020 to Jan 2021v3
  6. Collaborators: 2 to 3v2 See this version in full on ClinicalTrials.gov ↗
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
RIO is a placebo-controlled double-blinded two arm prospective phase II randomised controlled trial . This study will test the use of broadly neutralising antibodies (bNAbs) in participants with treated primary HIV infection (PHI).
Trial Details
NCT Number NCT04319367
Lead Sponsor Imperial College London
Collaborators: Bill and Melinda Gates Foundation, University of Oxford, Rockefeller University
Conditions HIV/AIDS and Infections
Enrollment 72 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov