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Artesunate Suppositories for the Treatment of HIV-negative Patients With Intra-anal HSIL

Study acronym: anal HSIL HIV-
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Primary completion date: Dec 28, 2024 to Dec 28, 2026
    • Study sites: 3 to 2
    • Study completion date: Dec 31, 2024 to Dec 31, 2026
    v11
  2. Primary completion date: Feb 28, 2024 to Dec 28, 2024
    • Study completion date: Aug 31, 2024 to Dec 31, 2024
    v10
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 48 to confirmed 17
    • Site details revised at 3 of 3 sites
    v9
  4. Site contacts updated at 1 of 3 sitesv8
  5. Site contacts updated at 1 of 3 sitesv7
Show 5 earlier versionsHide 5 earlier versions
  1. Re-verified, no change to tracked fieldsv6
  2. Trial status: Not Yet Recruiting to Recruitingv5 Show 4 more changesShow less
    • Primary completion date: Oct 31, 2023 to Feb 28, 2024
    • Study completion date: Apr 30, 2024 to Aug 31, 2024
    • Start date changed from estimate of Nov 15, 2022 to Feb 10, 2023
    • Site details revised at 3 of 3 sites
  3. Start date: Nov 4, 2022 to Nov 15, 2022
    • Eligibility criteria shortened, about 34 words
    v4
  4. Site contacts updated at 1 of 3 sitesv3
  5. Study sites: 1 to 3v2 Show 4 more changesShow less
    • Primary completion date: Oct 2023 to Oct 31, 2023
    • Study completion date: Apr 2024 to Apr 30, 2024
    • Start date: Oct 15, 2022 to Nov 4, 2022
    • Study description expanded, about 1 word
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 phase II double blind, placebo-controlled, randomized study of Artesunate suppositories for the treatment of HIV-negative men and women who have anal high grade squamous intraepithelial lesions (anal HSIL)
Trial Details
NCT Number NCT05555862
Lead Sponsor Frantz Viral Therapeutics, LLC
Collaborators: Amarex CRO, University of California, San Francisco, Anal Dysplasia Clinic MidWest, Laser Surgery Care
Conditions
(from sponsor)		 Anal High Grade Squamous Intraepithelial Lesion, Anal Precancerous Condition, AIN 2/3, HPV Infection, Anal Dysplasia, HPV Disease
Related terms Papillomavirus Infections
Enrollment 17 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov