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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-006277-92-NL
Enrollment
Unknown
Registered
2007-11-22
Start date
2009-06-23
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Trade Name: Aldara Product Name: Imiquimod Pharmaceutical Form: Cream INN or Proposed INN: IMIQUIMOD CAS Number: 99011-02-6 Concentration unit: % (W/W) percent weight/weight Concentration type: equal

Sponsors

Academic Medical Center, department of infectious diseases
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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 the several treatment options 2. To evaluate the cost effectiveness of local treatment of precancerous lesions. 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. ;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.—

Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026