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Treatment of anal intraepithelial neoplasia in HIV-positive patients, a triple-arm randomized clinical trial


- candidate number3074
- NTR NumberNTR1236
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-feb-2008
- Secondary IDs07/318 MEC
- Public TitleTreatment of anal intraepithelial neoplasia in HIV-positive patients, a triple-arm randomized clinical trial
- Scientific TitleTreatment of anal intraepithelial neoplasia in HIV-positive patients, a triple-arm randomized clinical trial
- ACRONYMTRAIN trial
- hypothesis
- Healt Condition(s) or Problem(s) studiedAnal intraepithelial neoplasia, HIV-positive patients
- Inclusion criteria1. Patient is > 18 years of age
2. Patient has a proven HIV infection
3. Patient is MSM or woman. Women of child- bearing potential should use highly effective methods of birth control during the duration of the study.
- Exclusion criteria1. History of anal carcinoma
2. History of chronic bowel disease
3. Life expectancy < 12 months
4. Pregnancy or lactation
5. Active i.v. drug user
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2008
- planned closingdate1-mrt-2011
- Target number of participants150
- Interventions- Cauterisation, max 5 times in 16 weeks
- Imiquimod cream, 1 sachet 3 times a week
- 5-Fluorouracil cream, 1 g, twice a week
- After inclusion of 25 patients in each treatment arm an interim analysis will be performed to evaluate side effects.
- Primary outcome- Histological resolution of AIN
- Relapse rate of AIN 24, 48 and 72 weeks after treatment
- Secondary outcome- Side effects of treatment
- QALY's, derived from the EQ-5D questionnaire
- Questionnaire sexual functioning: FSFI and IIEF -
- Costs of local treatment of precancerous lesions to prevent severe anal neoplasia
- HPV types and HPV load before and after treatment
- Single nucleotide polymorphisms (SNPs)in genes involved in the recognition of pathogens and the inflammatory response
- Presence of sexual transmitted co-infections
- Timepointst = 0 screening
treatment during 16 weeks
early evaluation at twenty weeks
follow up at 40, 64 and 88 weeks
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESProf. Dr. J.M. Prins
- CONTACT for SCIENTIFIC QUERIESProf. Dr. J.M. Prins
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryIn this study, we will screen 300 HIV+ MSM and women treated at the HIV outpatient clinics of the AMC, at two consecutive years, by performing high resolution anoscopy, with biopsy if lesions are seen. In case of AIN I-III in anal biopsies patients will be randomized (1:1:1) between three treatment regimens: local treatment of lesions with fluorouracil, imiquimod or with electro-coagulation. Primary endpoint is histological resolution of AIN 4 weeks after the end of treatment. The primary objective of this study is to establish the preferred treatment of AIN to prevent the development of severe anal neoplasia (persistent AIN III or anal carcinoma) in HIV+ MSM and HIV+ woman.
- Main changes (audit trail)
- RECORD15-feb-2008 - 1-apr-2009


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