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

• Sponsor: Universitaire Ziekenhuizen Leuven (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03742375
• Collaborator: Sciensano (Other)
• Enrollment: 24
• Location: 1
• Arm: 1
• Actual Duration (Months): 27
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Human Immunodeficiency Virus	Diagnostic Test: HPV genotyping	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Quantitative HPV Genotyping in Screening of Anal Intraepithelial Neoplasia in HIV-positive Patients
• Actual Study Start Date: Aug 1, 2018
• Actual Primary Completion Date: Nov 1, 2020
• Actual Study Completion Date: Nov 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HPV genotyping	Diagnostic Test: HPV genotyping; Quantitative HPV genotyping on anal swab

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospitals Leuven	Leuven		Belgium	3000

Sponsors and Collaborators

• Universitaire Ziekenhuizen Leuven
• Sciensano

Investigators

• Principal Investigator: Philip Roelandt, MD PhD, Universitaire Ziekenhuizen Leuven

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: prof. dr. Philip Roelandt, Assistant head of clinic Gastroenterology, Universitaire Ziekenhuizen Leuven
• ClinicalTrials.gov Identifier: NCT03742375
• Other Study ID Numbers: S60050
• First Posted: Nov 15, 2018
• Last Update Posted: Nov 4, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by prof. dr. Philip Roelandt, Assistant head of clinic Gastroenterology, Universitaire Ziekenhuizen Leuven: Human Papilloma Virus; Anal Intraepithelial Neoplasia
• Additional relevant MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Neoplasms

Study Results

No Results Posted as of Nov 4, 2020