Artesunate Suppositories for the Treatment of HIV-negative Patients With Intra-anal HSIL

• Status: Not yet recruiting
• Trial end date: 2024-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Frantz Viral Therapeutics, LLC
• Collaborators: Amarex CRO; Anal Dysplasia Clinic MidWest; Laser Surgery Care; University of California, San Francisco
• Treatments: Artemisinin; Artemisinins; Artenimol; Artesunate

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. 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:

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

• Cluster of differentiation (CD4) count < 200 for HIV seropositive patients

• Subjects infected with HIV-1 will be excluded if not on a stable, suppressive antiretroviral therapy (ART) regimen.

• 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 Efavirenz for HIV antiretroviral treatment

• Concomitant use of strong Uridine glucuronyl transferases (UGT) inhibitors

• Concomitant use of imiquimod or 5-fluorouracil (5-FU) for the duration of the study