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
  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:


Further study details as provided by Deutsche Luft und Raumfahrt:

Estimated Enrollment: 500
Study Start Date: March 2006
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
No publications provided

Responsible Party: Alexander Kreuter, Prof. Dr., Deutsche Luft und Raumfahrt
ClinicalTrials.gov Identifier: NCT00421486     History of Changes
Other Study ID Numbers: 01 KI 0501
Study First Received: January 10, 2007
Last Updated: February 5, 2014
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:
Acquired Immunodeficiency Syndrome
Communicable Diseases
HIV Infections
Infection
Papillomavirus Infections
DNA Virus Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Tumor Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 30, 2014