Topical treatment for anal high-grade lesions in HIV-negative individuals
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)
This study is testing if an ointment called artesunate can help treat anal high-grade lesions in HIV-negative adults better than a placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Frantz Viral Therapeutics, LLC Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Chicago, Illinois and 1 other locations) |
| Trial ID | NCT06206564 on ClinicalTrials.gov |
What this trial studies
This phase II clinical trial evaluates the efficacy of artesunate ointment in treating anal high-grade squamous intraepithelial lesions (HSIL) in HIV-negative adults. Participants are randomly assigned to receive either the artesunate ointment or a placebo over four 5-day cycles, with follow-up assessments using anoscopy at specified intervals. The primary goal is to assess the histopathologic response to the treatment, while secondary objectives include evaluating viral clearance and safety. Non-responders will receive standard care ablation.
Who should consider this trial
Good fit: Ideal candidates are HIV-negative adults aged 18 and older with biopsy-confirmed anal HSIL and a positive HPV test.
Not a fit: Patients with low-grade anal dysplasia, concurrent cancers, or those who are HIV-positive will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a non-surgical option for managing anal HSIL, potentially reducing the need for invasive procedures.
How similar studies have performed: While similar approaches have been explored, this specific use of artesunate ointment for anal HSIL is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chicago, Illinois and 1 other locations
- Anal Dysplasia Clinic MidWest — Chicago, Illinois, United States (Recruiting)
- Laser Surgery Care — New York, New York, United States (Recruiting)
Study contacts
- Study coordinator: Mihaela Plesa
- Email: fvtinfo@frantzgroup.com
- Phone: 440-255-1155
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.