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

NCT ID: NCT03742375

Last Updated: 2020-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2020-11-01

Brief Summary

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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

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Conditions

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Human Immunodeficiency Virus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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HPV genotyping

Group Type EXPERIMENTAL

HPV genotyping

Intervention Type DIAGNOSTIC_TEST

Quantitative HPV genotyping on anal swab

Interventions

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HPV genotyping

Quantitative HPV genotyping on anal swab

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Sciensano

OTHER_GOV

Sponsor Role collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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prof. dr. Philip Roelandt

Assistant head of clinic Gastroenterology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Philip Roelandt, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Locations

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University Hospitals Leuven

Leuven, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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S60050

Identifier Type: -

Identifier Source: org_study_id