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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03742375

Acronym

GAIN

Enrollment

Registered

2018-11-15

Start date

2018-08-01

Completion date

2020-11-01

Last updated

2020-11-04

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

Conditions

Human Immunodeficiency Virus

Keywords

Human Papilloma Virus, Anal Intraepithelial Neoplasia

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.

Interventions

DIAGNOSTIC_TESTHPV genotyping

Quantitative HPV genotyping on anal swab

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence of HPV subtypes in HIV-positive patients	1 minute	Retrieval of 1 anal swab before performing HRA to determine the HPV subtypes at that particular moment

Secondary

Measure	Time frame	Description
Correlation between high-resolution anoscopy findings and quantitative HPV genotyping	30 minutes up to 10 days	Performing HRA (30 minutes) with or without biopsies, results biopsies up to 10 days

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026