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

Human Immunodeficiency Virus Clinical Trial

— GAIN  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03742375
• Other study ID #: S60050
• Status: Terminated
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: November 1, 2020

Study information

• Verified date: November 2020
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: November 1, 2020
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus
• Neoplasms

Intervention

Diagnostic Test:
• HPV genotyping
Quantitative HPV genotyping on anal swab

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven	Sciensano

Country where clinical trial is conducted

Belgium, 

Outcome

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