Clinical trial NCT00421486: Oral Human Papillomavirus Infection in HIV-infected Men
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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Papillomavirus Infections
HIV Infections
Keywords: Oral human papillomavirus infection
HIV-infection
High-risk HPV viral load
Oral human papillomavirus infection in HIV-positive men
Treatment Experienced
Treatment Naive
Lead sponsor: Deutsche Luft und Raumfahrt
Sponsor class: OTHER_GOV
First posted: 2007-01-12
Enrollment: 500
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: HIV-infected men who have sex with men

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.

Eligibility criteria: Inclusion Criteria:

* HIV-infected men who have sex with men

Exclusion Criteria:

* None

Primary outcomes:
measure: Spectrum of HPV types and associated clinical lesions
timeFrame: swabs will be obtained approximately every 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: Department of Dermatology, Ruhr University Bochum
state: NRW
city: Köln
country: Germany
facility: Institute of Virology, University of Cologne
state: NRW
Study officials:
affiliation: Department of Dermatology, Ruhr University Bochum
name: Alexander Kreuter, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Dermatology, Ruhr University Bochum
name: Norbert Brockmeyer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Virology, University of Cologne
name: Ulrike Wieland, MD
role: PRINCIPAL_INVESTIGATOR
References: