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

• Conditions: Anal intraepithelial neoplasiaAnale intraepitheliale neoplasie

• Registration Number: NL-OMON25252
• Lead Sponsor: AMCPostbus 226601100 DDAmsterdam

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

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

Inclusion Criteria

1. Patient is > 18 years of age

2. Patient has a proven HIV infection

Exclusion Criteria

1. History of anal carcinoma

2. History of chronic bowel disease

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- Histological resolution of AIN<br /><br>- Relapse rate of AIN 24, 48 and 72 weeks after treatment

Secondary Outcome Measures

Name	Time	Method
- 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 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 pathogens and the inflammatory response<br /><br>- Presence of sexual transmitted co-infections