Artesunate Ointment for the Treatment of Anal HSIL in HIV-negative Participants

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Anal High-grade Squamous Intraepithelial Lesion, Anal HSIL, Anal HPV Infection, AIN

In brief

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)

Key facts

Study ID

NCT06206564

Run by

Frantz Viral Therapeutics, LLC

People needed

48

Starts

2024-01-12

Expected to finish

2026-12-31

Last updated by the study team

2025-05-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

• Anal Dysplasia Clinic MidWest — Chicago, Illinois, United States (enrolling)
• Laser Surgery Care — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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