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

Description

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)

Conditions

Anal High-grade Squamous Intraepithelial Lesion, Anal HSIL, Anal HPV Infection

Talk to us

Study Overview

On this page

Study Details

Study overview

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)

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)

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

Condition
Anal High-grade Squamous Intraepithelial Lesion
Intervention / Treatment

-

Contacts and Locations

Chicago

Anal Dysplasia Clinic MidWest, Chicago, Illinois, United States, 60614

New York

Laser Surgery Care, New York, New York, United States, 10011

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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:
  • 1. Serum alanine transaminase (SGPT/ALT) \< 5 x upper limit of normal (ULN)
  • 2. Serum aspartate transaminase (SGOT/AST) \< 5 x ULN
  • 3. Serum Bilirubin (total) \< 2.5 x ULN
  • 4. Serum Creatinine ≤ 1.5 x ULN
  • * Electrocardiogram (ECG) with no clinically significant findings as assessed by the Investigator.
  • * Weight ≥ 50kg
  • * Pregnant and nursing women
  • * Diagnosis of low-grade anal dysplasia (AIN 1, LSIL), without the concomitant diagnosis of anal HSIL, by HRA
  • * Concurrent anal, vulvar, cervical, or penile cancer
  • * HIV-seropositivity
  • * Currently receiving systemic chemotherapy or radiation therapy for another cancer.
  • * Patients who are on medical treatment with systemic immunosuppressants or steroids (e.g., active autoimmune disease). Participants using nasal steroid treatments for allergic conditions may participate in the study.
  • * Concomitant use of strong UGT (Uridine-diphosphate-glucuronosyltransferase) inhibitors
  • * Concomitant use of imiquimod or 5-fluorouracil (5-FU) for the duration of the study

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Frantz Viral Therapeutics, LLC,

Study Record Dates

2025-12-31