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

Launched by FRANTZ VIRAL THERAPEUTICS, LLC · Jan 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of artesunate ointment to treat anal high-grade squamous intraepithelial lesions (anal HSIL) in HIV-negative adults. Anal HSIL is a condition that can result from an infection with the human papillomavirus (HPV), which can lead to cancer if not treated. The trial is looking for adult men and women, 18 years and older, who have been diagnosed with anal HSIL and have tested positive for HPV. Participants must be able to provide informed consent and meet certain health criteria, such as having normal liver and kidney function.

If you decide to participate, you will receive either the artesunate ointment or a placebo (a cream that does not contain the active drug) without knowing which one you are getting. The study aims to see if the ointment can effectively treat anal HSIL and whether it is safe to use. It’s important to note that pregnant or nursing women, those with certain cancers, or people currently undergoing specific cancer treatments are not eligible for this trial. This study is currently recruiting participants, and it could be an opportunity for those affected by this condition to receive potential new treatment.

Gender

ALL

Eligibility criteria

• Inclusion 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
• Exclusion Criteria:
• • 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