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Oral Human Papillomavirus Infection in HIV-Infected Men

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Deutsche Luft und Raumfahrt.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Deutsche Luft und Raumfahrt
ClinicalTrials.gov Identifier:
NCT00421486
First received: January 10, 2007
Last updated: January 16, 2009
Last verified: January 2009
History of Changes
  Purpose

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 Intervention
Papillomavirus Infections
HIV Infections
 Procedure: Oral swabs for HPV-typing and high-risk HPV-determination

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Deutsche Luft und Raumfahrt:

Estimated Enrollment: 500
Study Start Date: March 2006
Estimated Study Completion Date: April 2010
Intervention Details:
    Procedure: Oral swabs for HPV-typing and high-risk HPV-determination
    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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

HIV-infected men who have sex with men

Criteria

Inclusion Criteria:

  • HIV-infected men who have sex with men

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00421486

Contacts
Contact: Alexander Kreuter, MD 0049/234/5093439 a.kreuter@derma.de

Locations
Germany
Department of Dermatology, Ruhr University Bochum Recruiting
Bochum, NRW, Germany, 44791
Contact: Alexander Kreuter, MD     0049/234/5093439     a.kreuter@derma.de    
Principal Investigator: Alexander Kreuter, MD            
Principal Investigator: Norbert Brockmeyer, MD            
Institute of Virology, University of Cologne Recruiting
Köln, NRW, Germany, 50935
Contact: Ulrike Wieland, MD            
Principal Investigator: Ulrike Wieland, MD            
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
  More Information

Additional Information:
Deutsches Kompetenznetz HIV/AIDS  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Kompetenznetz HIV/AIDS, BMBF
ClinicalTrials.gov Identifier: NCT00421486     History of Changes
Other Study ID Numbers: 01 KI 0501
Study First Received: January 10, 2007
Last Updated: January 16, 2009
Health Authority: Germany: Ethics Commission

Keywords provided by Deutsche Luft und Raumfahrt:
Oral human papillomavirus infection
HIV-infection
High-risk HPV viral load
 Oral human papillomavirus infection in HIV-positive men
Treatment Experienced
Treatment Naive

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Warts
Papillomavirus Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
 Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
DNA Virus Infections
Skin Diseases, Viral
Tumor Virus Infections
Neoplasms
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on February 26, 2013