Back to resultsQuantitative HPV Genotyping in Screening of Anal Intraepithelial Neoplasia in HIV-positive Patients (GAIN)
Primary Purpose
Human Immunodeficiency Virus
Status
Terminated
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
HPV genotyping
Sponsored by
About this trial
This is an interventional diagnostic trial for Human Immunodeficiency Virus focused on measuring Human Papilloma Virus, Anal Intraepithelial Neoplasia
Eligibility Criteria
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
Sites / Locations
- University Hospitals Leuven
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HPV genotyping
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Correlation between high-resolution anoscopy findings and quantitative HPV genotyping
Performing HRA (30 minutes) with or without biopsies, results biopsies up to 10 days
Full Information
NCT ID
NCT03742375
First Posted
October 10, 2018
Last Updated
November 2, 2020
Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
Sciensano
1. Study Identification
Unique Protocol Identification Number
NCT03742375
Brief Title
Quantitative HPV Genotyping in Screening of Anal Intraepithelial Neoplasia in HIV-positive Patients
Acronym
GAIN
Official Title
Quantitative HPV Genotyping in Screening of Anal Intraepithelial Neoplasia in HIV-positive Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Terminated
Why Stopped
COVID-19 pandemic
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
November 1, 2020 (Actual)
Study Completion Date
November 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
Sciensano
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus
Keywords
Human Papilloma Virus, Anal Intraepithelial Neoplasia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HPV genotyping
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
HPV genotyping
Intervention Description
Quantitative HPV genotyping on anal swab
Primary Outcome Measure Information:
Title
Incidence of HPV subtypes in HIV-positive patients
Description
Retrieval of 1 anal swab before performing HRA to determine the HPV subtypes at that particular moment
Time Frame
1 minute
Secondary Outcome Measure Information:
Title
Correlation between high-resolution anoscopy findings and quantitative HPV genotyping
Description
Performing HRA (30 minutes) with or without biopsies, results biopsies up to 10 days
Time Frame
30 minutes up to 10 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Roelandt, MD PhD
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Quantitative HPV Genotyping in Screening of Anal Intraepithelial Neoplasia in HIV-positive Patients
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