No registrations found.
ID
Source
Brief title
Health condition
Anal intraepithelial neoplasia
Anale intraepitheliale neoplasie
Sponsors and support
Postbus 22660
1100 DD
Amsterdam
Intervention
Outcome measures
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
Background summary
In 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.
Study design
t = 0 screening
treatment during 16 weeks
early evaluation at twenty weeks
follow up at 40, 64 and 88 weeks
Intervention
- 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.
F4- 217,
P.O. Box 22660
J.M. Prins
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5664380
j.m.prins@amc.uva.nl
F4- 217,
P.O. Box 22660
J.M. Prins
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5664380
j.m.prins@amc.uva.nl
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1191 |
| NTR-old | NTR1236 |
| Other | MEC : 07/318 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |