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)

ISRCTN	ISRCTN96401551
DOI	https://doi.org/10.1186/ISRCTN96401551
Protocol serial number	N0024115339
Sponsor	Department of Health (UK)
Funder	Homerton University Hospital NHS Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Mayura Nathan
Scientific

Department of Sexual Health
Homerton University Hospital NHS Trust
Homerton Row
London
E9 6SR
United Kingdom

Phone	+44 (0)20 8510 7979
Email	mayura.nathan@homerton.nhs.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Is it feasible to treat high-grade anal intraepithelial neoplasia (AIN 2/3) as defined by histological regression and clearance of high-risk human papillomavirus (HrHPV) by topical use of 5% Imiquimod?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Infections and Infestations: Papillomavirus
Intervention	Randomised controlled trial: A. 5% Imiquimod B. Placebo
Intervention type	Other
Primary outcome measure(s)	Complete clearance of AIN 2/3 lesions.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/09/2004

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target sample size at registration	64
Key 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.
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	01/10/2002
Date of final enrolment	30/09/2004

Department of Sexual Health

London
E9 6SR
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	24/09/2010		Yes	No