Condition category
Infections and Infestations
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
17/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mayura Nathan

ORCID ID

Contact details

Department of Sexual Health
Homerton University Hospital NHS Trust
Homerton Row
London
E9 6SR
United Kingdom
+44 (0)20 8510 7979
mayura.nathan@homerton.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0024115339

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Infections and Infestations: Papillomavirus

Intervention

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

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Complete clearance of AIN 2/3 lesions.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/10/2002

Overall trial end date

30/09/2004

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

64

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/10/2002

Recruitment end date

30/09/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Sexual Health
London
E9 6SR
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Funder name

Homerton University Hospital NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20729710

Publication citations

  1. Results

    Fox PA, Nathan M, Francis N, Singh N, Weir J, Dixon G, Barton SE, Bower M, A double-blind, randomized controlled trial of the use of imiquimod cream for the treatment of anal canal high-grade anal intraepithelial neoplasia in HIV-positive MSM on HAART, with long-term follow-up data including the use of open-label imiquimod., AIDS, 2010, 24, 15, 2331-2335, doi: 10.1097/QAD.0b013e32833d466c.

Additional files

Editorial Notes