Artesunate Ointment for the Treatment of Anal HSIL in HIV-negative Participants
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFrantz Viral Therapeutics, LLC
About this trial
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)
Eligibility criteria
Qualifiers
Adult men and women age ≥ 18 years
Capable of informed consent
Biopsy-confirmed intra-anal high-grade dysplasia (AIN 2, AIN 3, anal HSIL) by HRA.
Positive anal human papillomavirus (HPV) test.
Disqualifiers
Pregnant and nursing women
Diagnosis of low-grade anal dysplasia (AIN 1, LSIL), without the concomitant diagnosis of anal HSIL, by HRA
Concurrent anal, vulvar, cervical, or penile cancer
HIV-seropositivity
Trial design
Treatments tested in this trial
- Artesunate ointment
- Placebo
Treatment groups
48 Participants
are divided into 2 treatment groupsSponsors and collaborators
Frantz Viral Therapeutics, LLC
Lead sponsor
Laser Surgery Care, LLC
Collaborator
Anal Dysplasia Clinic MidWest
Collaborator
Source ClinicalTrials.gov