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

Human Papilloma Virus Clinical Trial

Official title:
A Phase I Study of Intra-Anally Administered Artesunate in Patients With High-Grade Anal Intraepithelial Neoplasia (AIN 2/3)

Clinical Trial Summary

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

Clinical Trial Description

Patients diagnosed with AIN 2/3 will be enrolled sequentially in treatment cohorts receiving different doses of Artesunate suppositories administered trans-anally. Doses of escalation will be 200 mg, 400 mg, and 600 mg. Treatment cohorts will consist of 2 or 3 cycles at each dose level. Suppositories will be administered daily for 5 days. Five days constitutes 1 cycle. Up to 3 cycles will be administered at Weeks 0, 2, and 4. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03100045
Study type Interventional
Source Johns Hopkins University
Contact
Status Completed
Phase Phase 1
Start date April 20, 2017
Completion date October 6, 2021
View Details
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