NCT05555862Active, not recruitingPhase 2
Artesunate Suppositories for the Treatment of HIV-negative Patients With Intra-anal HSIL
A Phase II Double Blind, Placebo-controlled, Randomized Trial of Artesunate Suppositories for the Treatment of HIV-negative Patients With Anal High-grade Squamous Intraepithelial Lesions (Anal HSIL)
Source: ClinicalTrials.gov · Last updated 18 May 2025
Brief summary (registry, in English)
This is a phase II double blind, placebo-controlled, randomized study of Artesunate suppositories for the treatment of HIV-negative men and women who have anal high grade squamous intraepithelial lesions (anal HSIL)
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 17 (actual)
- First submitted
- 22 Sept 2022
- Start date
- 10 Feb 2023
- Primary completion date
- 28 Dec 2026
- Lead sponsor
- Frantz Viral Therapeutics, LLC
- NCT number
- NCT05555862
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 17
- From 10 Feb 2023 to the primary completion date, 28 Dec 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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)
- Concomitant use of strong Uridine glucuronyl transferases (UGT) inhibitors
- Concomitant use of imiquimod or 5-fluorouracil (5-FU) for the duration of the study
Other illness
- HIV seropositivity
Other
- Pregnant and nursing women
Who the study is looking for
- 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. Patients must have residual anal HSIL lesions after diagnostic biopsies, as documented by HRA. This includes patients who are newly diagnosed with anal HSIL as well as those who have recurrent anal HSIL after medical therapy or surgical therapy. Patients who have intra-anal HSIL and also have peri-anal HSIL may be enrolled in the study.
- Women of childbearing potential agree to use birth control for the duration of the study.
- Laboratory values at Screening of:
- Serum alanine transaminase (SGPT/ALT) \< 5 x upper limit of normal (ULN)
- Serum aspartate transaminase (SGOT/AST) \< 5 x ULN
- Serum Bilirubin (total) \< 2.5 x ULN
- Serum Creatinine ≤ 1.5 x ULN
- Electrocardiogram (ECG) with no clinically significant findings as assessed by the Investigator.
- Weight ≥ 50kg
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Anal Dysplasia Clinic MidWest Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Laser Surgery Care Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.