Randomised, double-blind, placebo controlled, phase III, parallel group study in gay men using 5% Imiquimod for the treatment of high-grade anal intraepithelial neoplasia (AIN 2/3)

Completed

• Conditions: Infections and Infestations: Papillomavirus; Infections and Infestations; Viral agents as the cause of diseases classified to other chapters

• Registration Number: ISRCTN96401551
• Lead Sponsor: Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09-12
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 64

Inclusion Criteria

The study aims to recruit 64 patients on both sites (28 from Homerton).
1. Patients will be recruited from the pool of patients already attending the anoscopy clinics at Homerton University Hospital and Bart's and The London NHS Trusts.
2. Human Immunodeficiency Virus + (HIV+) patients will have been on antiretroviral combination therapy (HAART therapy) for at least 3 months prior to recruitment.

Exclusion Criteria

Does not match inclusion criteria

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complete clearance of AIN 2/3 lesions.

Secondary Outcome Measures

Name	Time	Method
ot provided at time of registration