Clinical Trials Logo
  1. Home
  2. Precancerous Conditions
  3. NCT03100045

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
See also
  Status Clinical Trial Phase
Recruiting NCT05329961 - Immunogenicity of the 9vHPV Vaccination 2-dose Regimen Among Children 4 to 8 Years Old, An Exploratory Immunogenicity Study Early Phase 1
Completed NCT05862844 - Promise Women Project N/A
Active, not recruiting NCT04199078 - Clinical Trial to Explore Papilocare Gel Efficacy to Repair of the Cervico-vaginal Mucosa With HPV High Risk Lesions. N/A
Recruiting NCT05566106 - Anal Follow-up of Patients With a Gynecological History of High-grade Lesion and More Induced HPV
Not yet recruiting NCT06229353 - Developing and Evaluating a Novel Approach to Improve HPV Vaccination Coverage Among High-risk, Under-immunized Adults Via the Emergency Department
Not yet recruiting NCT06436274 - Efficacy of Human Papillomavirus (HPV) Vaccination to Prevent Infection Among Women Living With HIV. Phase 4
Completed NCT01757392 - Candin Safety & Efficacy Study for the Treatment of Warts Phase 2
Active, not recruiting NCT04716127 - A Proximity-incentive Strategy for Cervical Cancer Screening N/A
Recruiting NCT05210348 - Clinical Evaluation of Detection of High Risk HPV in Urine
Recruiting NCT05835947 - Anal Cancer Risk In Women
Not yet recruiting NCT03947775 - HPV-SAVE_Merck_Sub-Study for Preventing Recurrence of HSIL Phase 2
Terminated NCT03404310 - Zinc Sulfate for Human Papillomavirus (HPV) N/A
Recruiting NCT03302858 - A Safety and Efficacy Trial of Circumferential Anal Canal Radiofrequency Ablation for High-Grade Anal Intraepithelial Neoplasia Using the BARRX™ Anorectal Wand Phase 2
Completed NCT03082950 - HPV Infections, Cancer of the Vulva and Therapeutical Success
Active, not recruiting NCT04950101 - Prevalence of Anal High-risk Human Papilloma Virus Infection and Abnormal Anal Cytology in Men Who Have Sex With Men Using Pre Exposure Prophylaxis N/A
Recruiting NCT05146895 - A Cohort Study of Hyperthermia and Imiquimod for the Treatment of Flat Warts N/A
Completed NCT04002154 - Clinical Trial to Explore the Papilocare Gel Efficacy to Repair the Cervico-vaginal Mucosa With Lesions Caused by HPV N/A
Recruiting NCT04232917 - Study of 2LPAPI® on the Clearance of Genital HR-HPV Infections. Phase 4
Active, not recruiting NCT03729518 - TORS De-Intensification Protocol Version 2.0: Dose and Volume Reduction in the Neck N/A
Recruiting NCT05640700 - Vaginal Microbiome and HPV Pre-malignant and Cervical Dysplasia