NCT06206564

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

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Frantz Viral Therapeutics, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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)

Detailed description

Eligible participants in this study are randomized 2:1 to receive either artesunate or placebo ointment for the treatment of anal HSIL. Both groups receive four 5-day cycles of ointment, at weeks 0, 2, 4, and 6. Participants are followed closely with anoscopy or high resolution anoscopy (HRA) at weeks 8, 18, 30, and 42. After the week 18 HRA visit, participants who have at least partial response will be followed with HRA at week 30. Participants who are found to be non-responders at week 18 will undergo standard of care ablation. Participants who are found to have anal HSIL at weeks 30 or 42 will be followed according to standard of care procedures. Primary Objective: To evaluate the complete and partial histopathologic response to four 5-day cycles of artesunate ointment in adult patients with biopsy-proven HPV-associated intra-anal HSIL (18 weeks). Secondary Objectives: Efficacy: To evaluate the viral clearance after four 5-day cycles of artesunate ointment To evaluate complete and partial intra-anal response To evaluate complete and partial peri-anal response To evaluate persistence of response throughout the study window Safety: To evaluate the safety of artesunate ointment for the treatment of intra-anal HSIL.

Conditions

• Anal High-grade Squamous Intraepithelial Lesion
• Anal HSIL
• Anal HPV Infection
• AIN

Interventions

Type	Name	Description
DRUG	Artesunate ointment	Four 5-day cycles of artesunate ointment given at weeks 0, 2, 4, 6
DRUG	Placebo	Four 5-day cycles of placebo ointment given at weeks 0, 2, 4, 6

Timeline

• Start date: 2024-01-12
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-01-16
• Last updated: 2025-05-18

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study