Oral Human Papillomavirus Infection in HIV-infected Men

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Deutsche Luft und Raumfahrt
Sponsor:
Information provided by (Responsible Party):
Alexander Kreuter, Deutsche Luft und Raumfahrt
ClinicalTrials.gov Identifier:
NCT00421486
First received: January 10, 2007
Last updated: February 5, 2014
Last verified: February 2014

January 10, 2007
February 5, 2014
March 2006
January 2016   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00421486 on ClinicalTrials.gov Archive Site
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Oral Human Papillomavirus Infection in HIV-infected Men
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

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Probability Sample

HIV-infected men who have sex with men

  • Papillomavirus Infections
  • HIV Infections
Procedure: Oral swabs for HPV-typing and high-risk HPV-determination
Oral swabs for HPV-typing and high-risk HPV-determination
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
January 2017
January 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV-infected men who have sex with men

Exclusion Criteria:

  • None
Male
18 Years and older
Yes
Contact: Alexander Kreuter, MD 0049/234/5093439 a.kreuter@derma.de
Germany
 
NCT00421486
01 KI 0501
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Alexander Kreuter, Deutsche Luft und Raumfahrt
Deutsche Luft und Raumfahrt
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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
Deutsche Luft und Raumfahrt
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP