Actively Recruiting
Artesunate Ointment for the Treatment of Anal HSIL in HIV-negative Participants
Led by Frantz Viral Therapeutics, LLC · Updated on 2025-05-18
48
Participants Needed
2
Research Sites
154 weeks
Total Duration
On this page
Sponsors
F
Frantz Viral Therapeutics, LLC
Lead Sponsor
L
Laser Surgery Care, LLC
Collaborating Sponsor
AI-Summary
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)
CONDITIONS
Official Title
Artesunate Ointment for the Treatment of Anal HSIL in HIV-negative Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
-
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.
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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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Anal Dysplasia Clinic MidWest
Chicago, Illinois, United States, 60614
Actively Recruiting
2
Laser Surgery Care
New York, New York, United States, 10011
Actively Recruiting
Research Team
M
Mihaela Plesa
CONTACT
A
Ahmad Bayat, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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