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Phase 2Recruiting

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

Sponsored by Frantz Viral Therapeutics, LLC

About this study

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)

Eligible participants in this study are randomized 2:1 to receive either artesunate or placebo ointment for the treatment of anal HSIL. Both groups receive four 5-day cycles of ointment, at weeks 0, 2, 4, and 6. 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 ointment in adult patie…

Where this study is enrolling (2)

Who can participate

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

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.