Oral Human Papillomavirus Infection in HIV-infected Men

NCT ID: NCT00421486

Last Updated: 2016-01-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2018-01-31

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.

Conditions

Papillomavirus Infections; HIV Infections

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Interventions

Oral swabs for HPV-typing and high-risk HPV-determination

Oral swabs for HPV-typing and high-risk HPV-determination

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• HIV-infected men who have sex with men

Exclusion Criteria

• None

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Deutsche Luft und Raumfahrt

OTHER_GOV

Sponsor Role: lead

Responsible Party

Alexander Kreuter

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexander Kreuter, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Dermatology, Ruhr University Bochum

Norbert Brockmeyer, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Dermatology, Ruhr University Bochum

Ulrike Wieland, MD

Role: PRINCIPAL_INVESTIGATOR

Institute of Virology, University of Cologne

Locations

Department of Dermatology, Ruhr University Bochum

Bochum, North Rhine-Westphalia, Germany

Site Status: RECRUITING

Institute of Virology, University of Cologne

Cologne, North Rhine-Westphalia, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Alexander Kreuter, MD

Role: CONTACT

a.kreuter@derma.de

0049/234/5093439

Facility Contacts

Alexander Kreuter, MD

Role: primary

a.kreuter@derma.de

0049/234/5093439

Ulrike Wieland, MD

Role: primary

Related Links

http://www.kompetenznetz-hiv.de

Deutsches Kompetenznetz HIV/AIDS

Other Identifiers

01 KI 0501

Identifier Type: -

Identifier Source: org_study_id