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Nine-valent HPV Vaccine to Prevent Persistent Oral HPV Infection in Men Living With HIV

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Jul 31, 2026 → Dec 31, 2026
See other at-risk trials from Weill Medical College of Cornell University

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Jul 31, 2026 to Dec 31, 2026v15
  2. Primary completion pushed from May 1, 2026 to Jul 31, 2026
    • Study completion pushed from Jul 1, 2026 to Jul 31, 2026
    v14
  3. Primary completion date: Nov 30, 2025 to May 1, 2026
    • Study completion date: Jan 31, 2026 to Jul 1, 2026
    • Collaborators reordered
    v13
  4. Site details revised at 1 of 3 sitesv12
  5. Study sites revised (3)
    • Collaborators: 6 to 7
    • Study description shortened, about 2 words
    v11
Show 9 earlier versionsHide 9 earlier versions
  1. Primary completion date: Apr 2026 to Nov 30, 2025
    • Study completion date: Apr 2026 to Jan 31, 2026
    • Study description expanded, about 187 words
    v10
  2. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 3 of 3 sites
    v9
  3. Site details revised at 1 of 3 sitesv8
  4. Primary and study completion dates: Apr 2025 to Apr 2026
    • Enrollment target: 500 to 700
    • Study description shortened, about 14 words
    v7
  5. Re-verified, no change to tracked fieldsv6
  6. Primary and study completion dates: Apr 2024 to Apr 2025
    • Site details revised at 2 of 3 sites
    v5
  7. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 2021 to Feb 23, 2021
    • Site details revised at 3 of 3 sites
    • Collaborators: 5 to 6
    v4
  8. Start date: Oct 2020 to Jan 2021v3
  9. Start date: Apr 2020 to Oct 2020v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a randomized, double-blinded, placebo-controlled Phase III interventional trial of the nine-valent HPV vaccine (9vHPV) to prevent persistent oral HPV infection in adult men living with HIV.
Trial Details
NCT Number NCT04255849
Lead Sponsor Weill Medical College of Cornell University
Collaborators: H. Lee Moffitt Cancer Center and Research Institute, University of Sao Paulo, University of Puerto Rico, National Cancer Institute (NCI), Merck Sharp & Dohme LLC, University of California, San Diego, Instituto Nacional de Salud Publica, Mexico
Conditions
(from sponsor)		 HPV Positive Oropharyngeal Squamous Cell Carcinoma, HIV-1-infection, HPV Infection
Related terms Papillomavirus Infections
Enrollment 700 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov