Intra-Anally Administered Artesunate in Patients With High-Grade Anal Intraepithelial Neoplasia (AIN 2/3)

• Status: Completed
• Trial end date: 2021-10-06
• Target enrollment: 0
• Participant gender: All

Summary

This open label study investigates a novel non-surgical approach to the treatment of HPV-associated anal intraepithelial neoplasia, using Artesunate suppositories.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborators: Frantz Medical Group; Frantz Viral Therapeutics, LLC; University of Wisconsin, Madison
• Treatments: Artemisinin; Artemisinine; Artemisinins; Artesunate

Criteria

Inclusion Criteria:

• Age ≥ 18 years

• Biopsy-confirmed high-grade anal dysplasia (AIN 2, AIN 3, HSIL) by high resolution anoscopy (HRA)

• Female of childbearing potential: negative urine pregnancy test

• Able to provide informed consent

• Patients who have the ability to collaborate with planned follow-up (transportation, compliance history, etc.).

• Weight ≥50 kg.

Exclusion Criteria:

• Diagnosis of low-grade anal dysplasia (AIN 1, LSIL) by high resolution anoscopy

• Known anal, vulvar, cervical, or penile cancer

• CD4 count < 200 at the time of consideration for entry into this study

• Unable to provide informed consent

• 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)

• Extensive anal condyloma precludes the ability for the clinician to visualize HSIL during HRA