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

Phase 4

• Conditions: anal dysplasia; 10017990; 10040900

• Registration Number: NL-OMON32379
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

- Patient is * 18 years of age
- Patient has a proven HIV infection
- Patient is MSM or woman.

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Histological resolution of AIN 4 weeks after the end of treatment and relapse<br /><br>rate at 24, 48 and 72 weeks after treatment.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Side effects of treatment<br /><br>- QALY*s, derived from the EQ-5D questionnaire<br /><br>- Questionnaire sexual functioning: FSFI and IIEF -<br /><br>- Costs of local treatment of precancerous lesions to prevent severe anal<br /><br>neoplasia<br /><br>- HPV types and HPV load before and after treatment<br /><br>- Single nucleotide polymorphisms (SNPs)in genes involved in the recognition of<br /><br>pathogens and the inflammatory response<br /><br>- Presence of sexual transmitted co-infections</p><br>