RecruitingPhase 2NCT06206564

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)


Sponsor

Frantz Viral Therapeutics, LLC

Enrollment

48 participants

Start Date

Jan 12, 2024

Study Type

INTERVENTIONAL

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)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether an artesunate ointment (derived from an anti-malaria drug) can treat high-grade abnormal cells inside the anus caused by HPV. These precancerous cells are called anal HSIL (high-grade squamous intraepithelial lesions) and can progress to anal cancer if untreated. **You may be eligible if...** - You are 18 or older (men or women) - A biopsy has confirmed high-grade anal abnormal cells (AIN 2, AIN 3, or anal HSIL) - You have tested positive for HPV in the anal area - Women of childbearing potential agree to use contraception during the study - You are HIV-negative **You may NOT be eligible if...** - You have HIV - You are pregnant or breastfeeding - You have had recent anal treatments that would interfere with the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGArtesunate ointment

Four 5-day cycles of artesunate ointment given at weeks 0, 2, 4, 6

DRUGPlacebo

Four 5-day cycles of placebo ointment given at weeks 0, 2, 4, 6


Locations(2)

Anal Dysplasia Clinic MidWest

Chicago, Illinois, United States

Laser Surgery Care

New York, New York, United States

View Full Details on ClinicalTrials.gov

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NCT06206564