Artesunate Suppositories for the Treatment of HIV-negative Patients With Intra-anal HSIL

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Anal High Grade Squamous Intraepithelial Lesion, Anal Precancerous Condition, AIN 2/3, HPV Infection, Anal Dysplasia, HPV Disease

In brief

This is a phase II double blind, placebo-controlled, randomized study of Artesunate suppositories for the treatment of HIV-negative men and women who have anal high grade squamous intraepithelial lesions (anal HSIL)

Key facts

Study ID

NCT05555862

Run by

Frantz Viral Therapeutics, LLC

People needed

17

Starts

2023-02-10

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. Patients must have residual anal HSIL lesions after diagnostic biopsies, as documented by HRA. This includes patients who are newly diagnosed with anal HSIL as well as those who have recurrent anal HSIL after medical therapy or surgical therapy. Patients who have intra-anal HSIL and also have peri-anal HSIL may be enrolled in the study.
• 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)
• Concomitant use of strong Uridine glucuronyl transferases (UGT) 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
• Laser Surgery Care — New York, New York, United States

Full record on ClinicalTrials.gov

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