Oral Human Papillomavirus Infection in HIV-infected Men

Sponsor

Deutsche Luft und Raumfahrt (Other)

Overall Status

Unknown status

CT.gov ID

NCT00421486

Collaborator

(none)

500

Enrollment

Locations

142.1

Duration (Months)

250

Patients Per Site

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Papillomavirus Infections HIV Infections	Procedure: Oral swabs for HPV-typing and high-risk HPV-determination

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 Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Incidence, Prevalence, Spectrum of HPV-types, and Viral Load Determination of High-risk Human Papillomavirus Infection of the Oral Cavity in HIV-infected Men Who Have Sex With Men

Study Start Date :

Mar 1, 2006

Anticipated Primary Completion Date :

Jan 1, 2017

Anticipated Study Completion Date :

Jan 1, 2018

Outcome Measures

Primary Outcome Measures

Spectrum of HPV types and associated clinical lesions [swabs will be obtained approximately every 6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

HIV-infected men who have sex with men

Exclusion Criteria:

None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Dermatology, Ruhr University Bochum	Bochum	NRW	Germany	44791
2	Institute of Virology, University of Cologne	Köln	NRW	Germany	50935

Sponsors and Collaborators

Deutsche Luft und Raumfahrt

Investigators

Principal Investigator: Alexander Kreuter, MD, Department of Dermatology, Ruhr University Bochum
Principal Investigator: Norbert Brockmeyer, MD, Department of Dermatology, Ruhr University Bochum
Principal Investigator: Ulrike Wieland, MD, Institute of Virology, University of Cologne