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)

What this Trial Is About

Researchers are evaluating artesunate ointment in a phase II, double-blind, placebo-controlled, randomized study for adults with biopsy-confirmed anal high-grade squamous intraepithelial lesions (anal HSIL) who are HIV-negative. The study aims to assess the complete and partial tissue response to the ointment, as well as evaluate viral clearance and safety. Anal HSIL is related to HPV infection and requires effective treatment options to prevent progression. Participants are randomly assigned in a 2:1 ratio to receive either artesunate ointment or placebo. Both groups apply four 5-day cycles of ointment at weeks 0, 2, 4, and 6. Follow-up includes anoscopy or high-resolution anoscopy (HRA) visits at weeks 8, 18, 30, and 42. Those showing partial or complete response at week 18 continue follow-up with HRA at week 30. Non-responders at week 18 receive standard ablation treatment. During the study, participants undergo regular anoscopy or HRA exams to monitor lesion response and viral clearance. Safety is closely monitored throughout. Participants with persistent anal HSIL at weeks 30 or 42 follow standard care procedures. The primary outcome is the histopathologic response by week 18, with secondary outcomes including HPV clearance and response persistence through week 42. The total study period extends up to 42 weeks, with ongoing safety evaluation.

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