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Quantitative HPV Genotyping in Screening of Anal Intraepithelial Neoplasia in HIV-positive Patients

Not Applicable
Terminated
Conditions
Human Immunodeficiency Virus
Interventions
Diagnostic Test: HPV genotyping
Registration Number
NCT03742375
Lead Sponsor
Universitaire Ziekenhuizen KU Leuven
Brief Summary

The pathophysiology from anal HPV infection to Anal Intraepithelial Neoplasia is less well understood than cervical HPV infection. In cervical screening programs it is well accepted that the sole presence of a high-risk HPV strain (irrespective of number of viral particles) is sufficient to justify further investigation and treatment. The investigators hypothesize that in anal HPV infection not only the presence but the extent of HPV infection (single genotype viral load) or combination of different HPV genotypes (cumulative viral load) is of importance in determining the risk of anal dysplasia.

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
Male
Target Recruitment
24
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
HPV genotypingHPV genotyping-
Primary Outcome Measures
NameTimeMethod
Incidence of HPV subtypes in HIV-positive patients1 minute

Retrieval of 1 anal swab before performing HRA to determine the HPV subtypes at that particular moment

Secondary Outcome Measures
NameTimeMethod
Correlation between high-resolution anoscopy findings and quantitative HPV genotyping30 minutes up to 10 days

Performing HRA (30 minutes) with or without biopsies, results biopsies up to 10 days

Trial Locations

Locations (1)

University Hospitals Leuven

🇧🇪

Leuven, Belgium

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