Artesunate Ointment for the Treatment of Anal HSIL in HIV-negative Participants
Recruiting · NCT06206564 · Interventional (participants receive a specific treatment) · Lead sponsor: Frantz Viral Therapeutics, LLC
View the official record on ClinicalTrials.gov →Interventions studied
Artesunate ointmentPlacebo
What this trial is about
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)
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
- Women of childbearing potential agree to use birth control for the duration of the study.
- Laboratory values at Screening of:
- Serum alanine transaminase (SGPT/ALT) \< 5 x upper limit of normal (ULN)
- Serum aspartate transaminase (SGOT/AST) \< 5 x ULN
- Serum Bilirubin (total) \< 2.5 x ULN
- Serum Creatinine ≤ 1.5 x ULN
- Electrocardiogram (ECG) with no clinically significant findings as assessed by the Investigator.
- Weight ≥ 50kg
Exclusion criteria
- 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
- Currently receiving systemic chemotherapy or radiation therapy for another cancer.
- Patients who are on medical treatment with systemic immunosuppressants or steroids (e.g., active autoimmune disease). Participants using nasal steroid treatments for allergic conditions may participate in the study.
- Concomitant use of strong UGT (Uridine-diphosphate-glucuronosyltransferase) inhibitors
- Concomitant use of imiquimod or 5-fluorouracil (5-FU) for the duration of the study
Where it is running
2 locations listed across 2 US states.
- Anal Dysplasia Clinic MidWest - Chicago, Illinois, United States
- Laser Surgery Care - New York, New York, United States