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

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.

t = 0 screening

treatment during 16 weeks

early evaluation at twenty weeks

follow up at 40, 64 and 88 weeks

- 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.