A Phase II Double Blind, Placebo-controlled, Randomized Trial of Artesunate Ointment for the Treatment of HIV-negative Patients With Anal High-grade Squamous Intraepithelial Lesions (Anal HSIL)
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)
• 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