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

Universitaire Ziekenhuizen KU Leuven

Status: Terminated

Conditions: Human Immunodeficiency Virus

Treatments: Diagnostic Test: HPV genotyping

Study type: Interventional

Funder types: Other

Identifiers

NCT03742375

S60050

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

HPV genotyping

Experimental group

Treatment:

Diagnostic Test: HPV genotyping