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

NCT03742375 | Terminated

• 1 other identifier: S60050
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Immunodeficiency Virus

Keywords

Human Papilloma Virus; Anal Intraepithelial Neoplasia

Outcome Measures

Primary Outcomes (1)

• 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

  1 minute

Secondary Outcomes (1)

• Correlation between high-resolution anoscopy findings and quantitative HPV genotyping

  30 minutes up to 10 days

Study Arms (1)

HPV genotyping

EXPERIMENTAL

Diagnostic Test: HPV genotyping

Interventions

HPV genotyping DIAGNOSTIC_TEST

Quantitative HPV genotyping on anal swab

HPV genotyping

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Documented AIN (treated or untreated)
• Local anal inflammation (proctitis) and/or acute fissure

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Sciensano: collaborator

Study Sites (1)

University Hospitals Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Philip Roelandt, MD PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant head of clinic Gastroenterology

Study Record Dates

• First Submitted: October 10, 2018
• First Posted: November 15, 2018
• Study Start: August 1, 2018
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2020
• Last Updated: November 4, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)