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

Conditions: anal intraepithealial neoplasia in HIV-positive patients
MedDRA version: 9.1Level: LLTClassification code 10059315Term: Anal intraepithelial neoplasia

Registration Number: EUCTR2007-006277-92-NL

Lead Sponsor: Academic Medical Center, department of infectious diseases

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

•Patient is = 18 years of age
•Patient has a proven HIV infection
•Patient is MSM or woman. Women of child-bearing potential should use highly effective methods of birth control during the duration of the study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-History of anal carcinoma
-History of chronic bowel disease
-Life expectancy < 12 months
-Pregnancy or lactation
-Active i.v. drug user

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To establish the preferred treatment of AIN to accomplish histological resolution early (4 weeks) and late (24, 48 and 72 months) after treatment, in HIV+ homosexual men and HIV+ women;Secondary Objective: 1. To evaluate adverse events, quality of life and sexual functioning for<br>the several treatment options<br>2. To evaluate the cost effectiveness of local treatment of precancerous lesions.<br>3. To examine the role of the several relevant host and viral characteristics with regard to treatment success and recurrence rates after treatment of AIN I-III. This includes the evaluation of the role and influence of co-infections (syphilis, chlamydia,) and HIV-load on HPV rectal persistance and oncogenesis. <br>;Primary end point(s): Histological resolution of AIN 4 weeks after the end of treatment and relapse rate at 24, 48 and 72 weeks after end treatment.

Secondary Outcome Measures