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)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN96401551

Enrollment

Registered

2003-09-12

Start date

2002-10-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Randomised controlled trial: A. 5% Imiquimod B. Placebo

Eligibility

Sex/Gender

Male

Inclusion criteria

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

Exclusion criteria: Does not match inclusion criteria

Design outcomes

Primary

Measure	Time frame
Complete clearance of AIN 2/3 lesions.	—

Secondary

Measure	Time frame
Not provided at time of registration	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026