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Artesunate Ointment for the Treatment of Anal HSIL in HIV-negative Participants

Study acronym: ART-AIN IIB-2
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary and study completion dates: Dec 31, 2025 to Dec 31, 2026
    • Site contacts updated at 2 of 2 sites
    v5
  2. 2 versions Re-verified since May 21, 2024, no change to tracked fieldsv3-v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 15, 2024 to Jan 12, 2024
    • Site details revised at 2 of 2 sites
    v2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 phase II double blind, placebo-controlled, randomized study of artesunate ointment for the treatment of HIV-negative men and women who have anal high grade squamous intraepithelial lesions (anal HSIL)
Trial Details
NCT Number NCT06206564
Lead Sponsor Frantz Viral Therapeutics, LLC
Collaborators: Laser Surgery Care, LLC, Anal Dysplasia Clinic MidWest
Conditions
(from sponsor)		 Anal High-grade Squamous Intraepithelial Lesion, Anal HSIL, Anal HPV Infection, AIN
Enrollment 48 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov