Human Papilloma Virus Clinical Trial
— ART-AINOfficial title:
A Phase I Study of Intra-Anally Administered Artesunate in Patients With High-Grade Anal Intraepithelial Neoplasia (AIN 2/3)
Verified date | November 2021 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This open label study investigates a novel non-surgical approach to the treatment of HPV-associated anal intraepithelial neoplasia, using Artesunate suppositories.
Status | Completed |
Enrollment | 18 |
Est. completion date | October 6, 2021 |
Est. primary completion date | October 6, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins Hospital | Baltimore | Maryland |
United States | University of Wisconsin Carbone Cancer Center | Madison | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | Frantz Viral Therapeutics, LLC, University of Wisconsin, Madison |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of treatment-emergent adverse events (Safety and tolerability) of Artesunate suppositories for the treatment of anal intraepithelial neoplasia (AIN2/3) | Number of patients with serious adverse events or dose limiting toxicities related to the study medication, according to CTCAE4.0 | 6 weeks from the date of the first dosing | |
Secondary | Number of patients with histologic regression of anal intraepithelial neoplasia (AIN2/3) to AIN1 or less | Number of patients with no AIN2/3 as assessed by high resolution anoscopy and biopsy | 16 weeks | |
Secondary | Number of patients with histologic regression of anal intraepithelial neoplasia (AIN2/3) to AIN1 or less | Number of patients with no AIN2/3 as assessed by high resolution anoscopy and biopsy | 28 weeks | |
Secondary | Number of patients with viral clearance of human papillomavirus (HPV) virus measured by HPV genotyping | Number of patients with HPV genotypes present at study entry which become undetectable during the study window | 40 weeks |
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