Oral Human Papillomavirus Infection in HIV-infected Men

• Conditions: Papillomavirus Infections; HIV Infections

• Registration Number: NCT00421486
• Lead Sponsor: Deutsche Luft und Raumfahrt

Brief Summary

Human papillomavirus (HPV)-infection belong to the most common sexually transmitted diseases worldwide. HIV-infected men having sex with men /MSM) are strongly associated with a higher prevalence of genitoanal HPV-infection, and perianal HPV-infections have been detected in up to 90% of HIV-positive men. The data concerning the incidence of oral HPV-infection in HIV-positive men, especially in the era of highly antiretroviral therapy, are conflicting. Thus, this prospective study mainly focuses on the incidence and prevalence of oral HPV-infection, spectrum of HPV-types, and oral high-risk HPV viral load in HIV-positive men.

Detailed Description

Human papillomavirus (HPV)-infection belong to the most common sexually transmitted diseases worldwide. Estimated prevalences of subclinical genital HPV-infection in the immunocompetent sexually active population range from 10 to above 50%. Genetic or iatrogenic immunosuppression is known to play a decisive role in the initiation of a variety of cutaneous neoplasias and their precursor lesions. In this context, HPV-associated anogenital malignancies occur with high frequency in patients with HIV-infection. In several studies, perianal HPV-infections have been detected in up to 90% of HIV-positive men and a high incidence of anal dysplasia has been reported in these patients. The data concerning the incidence of oral HPV-infection in HIV-positive men, especially in the era of highly antiretroviral therapy, are conflicting. Thus, this prospective study mainly focuses on the incidence and prevalence of oral HPV-infection, spectrum of HPV-types, and oral high-risk HPV viral load in HIV-positive men.

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2007-01-10
• Study First Submitted QC: 2007-01-11
• Study First Posted: 2007-01-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-20
• Last Update Posted: 2016-01-21
• Primary Completion: 2017-01
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 500

Inclusion Criteria

• HIV-infected men who have sex with men

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Spectrum of HPV types and associated clinical lesions	swabs will be obtained approximately every 6 months

Trial Locations

Locations (2)

Institute of Virology, University of Cologne; 🇩🇪 Köln, NRW, Germany

Department of Dermatology, Ruhr University Bochum; 🇩🇪 Bochum, NRW, Germany