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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Frantz Viral Therapeutics, LLC
Study ID
NCT06206564
Phase
PHASE2
Status
Recruiting
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Conditions

  • AIN
  • Anal HPV Infection
  • Anal HSIL
  • Anal High-grade Squamous Intraepithelial Lesion

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Artesunate ointment — DRUG
    Four 5-day cycles of artesunate ointment given at weeks 0, 2, 4, 6
  • Placebo — DRUG
    Four 5-day cycles of placebo ointment given at weeks 0, 2, 4, 6

Study Details

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)

Key Dates

Start date
Jan 12, 2024
Status verified
May 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Artesunate
  • Placebo Comparator: Placebo ointment

Primary Outcome Measure

Complete and partial response by week 18 [ Time Frame: 18 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Anal Dysplasia Clinic MidWestChicagoIllinois60614
Gary Bucher, MD
[email protected]
312-623-2625
Emily Miller
3126232625
Gary Bucher, MD (PRINCIPAL_INVESTIGATOR)
Emily Miller, APN (SUB_INVESTIGATOR)
Laser Surgery CareNew YorkNew York10011
Taylor Ridley
[email protected]
212-242-6500
Joseph Terlizzi, MD (PRINCIPAL_INVESTIGATOR)

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Anal Dysplasia Clinic MidWest· Chicago, ILLaser Surgery Care· New York, NY

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