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 groupsLocations
2Anal Dysplasia Clinic MidWest60614, ChicagoIllinois, United States
Laser Surgery Care10011, New YorkNew York, United States
Sponsors and collaborators
Frantz Viral Therapeutics, LLC
Lead sponsor
Laser Surgery Care, LLC
Collaborator
Anal Dysplasia Clinic MidWest
Collaborator
Source ClinicalTrials.gov