NCT05555862

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• 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 suppositories 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 suppositories for the treatment of anal HSIL. Both groups receive four 5-day cycles of suppositories, at weeks 0, 2, 4, and 6. At least two of the dosing visits are done in person. The remaining dosing visits may be done as telehealth visits (suppositories are mailed to the patient's home). 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 suppositories 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 suppositories in adults with biopsy-proven HPV-associated intra-anal anal HSIL over the study window (42 weeks) * To evaluate complete and partial intra-anal histopathologic response after the week 18 time point but over the study window (30 weeks). * To evaluate complete and partial peri-anal histopathologic response following artesunate suppositories over the course of the study (42 weeks). * To evaluate persistence of response throughout the study window (42 weeks) Safety: To evaluate the safety of artesunate suppositories for the treatment of intra-anal HSIL.

Conditions

• Anal High Grade Squamous Intraepithelial Lesion
• Anal Precancerous Condition
• AIN 2/3
• HPV Infection
• Anal Dysplasia
• HPV Disease

Interventions

Type	Name	Description
DRUG	Artesunate	artesunate formulated as intra-anal suppositories
DRUG	Placebo	placebo intra-anal suppository

Timeline

• Start date: 2023-02-10
• Primary completion: 2026-12-28
• Completion: 2026-12-31
• First posted: 2022-09-27
• Last updated: 2025-05-18

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study