RECRUITING

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

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Conditions

Anal High-grade Squamous Intraepithelial LesionAnal HSILAnal HPV Infection

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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)

Official Title

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)

Quick Facts

Study Start:2024-01-12
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06206564

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult men and women age ≥ 18 years
  2. * Capable of informed consent
  3. * Biopsy-confirmed intra-anal high-grade dysplasia (AIN 2, AIN 3, anal HSIL) by HRA.
  4. * Positive anal human papillomavirus (HPV) test.
  5. * Women of childbearing potential agree to use birth control for the duration of the study.
  6. * Laboratory values at Screening of:
  7. 1. Serum alanine transaminase (SGPT/ALT) \< 5 x upper limit of normal (ULN)
  8. 2. Serum aspartate transaminase (SGOT/AST) \< 5 x ULN
  9. 3. Serum Bilirubin (total) \< 2.5 x ULN
  10. 4. Serum Creatinine ≤ 1.5 x ULN
  11. * Electrocardiogram (ECG) with no clinically significant findings as assessed by the Investigator.
  12. * Weight ≥ 50kg
  1. * Pregnant and nursing women
  2. * Diagnosis of low-grade anal dysplasia (AIN 1, LSIL), without the concomitant diagnosis of anal HSIL, by HRA
  3. * Concurrent anal, vulvar, cervical, or penile cancer
  4. * HIV-seropositivity
  5. * Currently receiving systemic chemotherapy or radiation therapy for another cancer.
  6. * 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.
  7. * Concomitant use of strong UGT (Uridine-diphosphate-glucuronosyltransferase) inhibitors
  8. * Concomitant use of imiquimod or 5-fluorouracil (5-FU) for the duration of the study

Contacts and Locations

Study Contact

Mihaela Plesa
CONTACT
440-255-1155
fvtinfo@frantzgroup.com
Ahmad Bayat, MD
CONTACT
301-956-2523
ahmadb@amarexcro.com

Study Locations (Sites)

Anal Dysplasia Clinic MidWest
Chicago, Illinois, 60614
United States
Laser Surgery Care
New York, New York, 10011
United States

Collaborators and Investigators

Sponsor: Frantz Viral Therapeutics, LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-12
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2024-01-12
Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

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