No registrations found.
ID
Source
Brief title
Health condition
Anale intraepitheliale neoplasia in HIV-positive patients
Sponsors and support
- St. Josef Hospital, Ruhr Universität, Bochum
Intervention
Outcome measures
Primary outcome
- Histological resolution of AIN
- Relapse rate at 6 and 12 months
Secondary outcome
- Side effects of treatment
- HPV types and load before and after treatment
Background summary
In this study we will treat about fourty HIV+ MSM with inra-anal anal intrapithelial neoplasia (AIN) with local Efudix for a period of 16 weeks. Primary endpoint is histological resolution at 16 weeks. Follow up will take place after 6 and 12 months.
Study objective
5-FU cream is a potential treatment option for intra-anal AIN
Study design
t = 0 start treatment
t= 16 weeks early evaluation
t = 24 weeks: follow up
t = 48 weeks: follow up
Intervention
5-Fluorouracil cream twice a week intra-analy during 16 weeks
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. Patients is MSM
Exclusion criteria
1. History of anal carcinoma
2 .History of chronic bowel disease
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 | NL1358 |
| NTR-old | NTR1415 |
| Other | TRAIN trial : MEC 07/318 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |