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

Universitaire Ziekenhuizen KU Leuven24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Human Immunodeficiency Virus

Interventions

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria * Stable HIV disease (i.e. receiving ART for at least 1 year, no adverse drug reactions requiring regular monitoring, no current illnesses or pregnancy, good understanding of lifelong adherence and evidence of treatment success: two consecutive undetectable viral load measures) * Referred for high-resolution anoscopy Exclusion criteria * Documented AIN (treated or untreated) * Local anal inflammation (proctitis) and/or acute fissure

Outcomes

Primary Outcomes

Incidence of HPV subtypes in HIV-positive patients

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

Time frame: 1 minute

Secondary Outcomes

Correlation between high-resolution anoscopy findings and quantitative HPV genotyping

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

Time frame: 30 minutes up to 10 days