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 |
| Secondary identifying numbers | N0024115339 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 17/09/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Mayura Nathan
Scientific
Scientific
Department of Sexual Health
Homerton University Hospital NHS Trust
Homerton Row
London
E9 6SR
United Kingdom
| Phone | +44 (0)20 8510 7979 |
|---|---|
| mayura.nathan@homerton.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | Complete clearance of AIN 2/3 lesions. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/10/2002 |
| Completion date | 30/09/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Sexual Health
London
E9 6SR
United Kingdom
E9 6SR
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Hospital/treatment centre
Homerton University Hospital NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 24/09/2010 | Yes | No |
