Anal intraepithelial neoplasia Anale intraepitheliale neoplasie
Conditions
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 anal
Sponsors
AMC
Postbus 22660
1100 DD
Amsterdam
Eligibility
Inclusion criteria
Inclusion criteria: 1. 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 criteria
Exclusion criteria: 1. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Histological resolution of AIN - Relapse rate of AIN 24, 48 and 72 weeks after treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| - 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 | — |
Contacts
Public ContactJ.M. Prins
Academic Medical Center (AMC), Department of Internal Medicine, F4- 217, P.O. Box 22660
Outcome results
None listed