Status:
RECRUITING
Artesunate Ointment for the Treatment of Anal HSIL in HIV-negative Participants
Lead Sponsor:
Frantz Viral Therapeutics, LLC
Collaborating Sponsors:
Laser Surgery Care, LLC
Anal Dysplasia Clinic MidWest
Conditions:
Anal High-grade Squamous Intraepithelial Lesion
Anal HSIL
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 (...
Detailed Description
Eligible participants in this study are randomized 2:1 to receive either artesunate or placebo ointment for the treatment of anal HSIL. Both groups receive four 5-day cycles of ointment, at weeks 0, 2...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06206564
Start Date
January 12 2024
End Date
December 31 2026
Last Update
May 18 2025
Active Locations (2)
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1
Anal Dysplasia Clinic MidWest
Chicago, Illinois, United States, 60614
2
Laser Surgery Care
New York, New York, United States, 10011