Oral Human Papillomavirus Infection in HIV-infected Men

January 20, 2016 updated by: Alexander Kreuter, Deutsche Luft und Raumfahrt

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
    • NRW
      • Bochum, NRW, Germany, 44791
        • Recruiting
        • Department of Dermatology, Ruhr University Bochum
        • Contact:
        • Principal Investigator:
          • Alexander Kreuter, MD
        • Principal Investigator:
          • Norbert Brockmeyer, MD
      • Köln, NRW, Germany, 50935
        • Recruiting
        • Institute of Virology, University of Cologne
        • Contact:
          • Ulrike Wieland, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

HIV-infected men who have sex with men

Description

Inclusion Criteria:

  • HIV-infected men who have sex with men

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Spectrum of HPV types and associated clinical lesions
Time Frame: swabs will be obtained approximately every 6 months
swabs will be obtained approximately every 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Deutsche Luft und Raumfahrt

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (ANTICIPATED)

January 1, 2017

Study Completion (ANTICIPATED)

January 1, 2018

Study Registration Dates

First Submitted

January 10, 2007

First Submitted That Met QC Criteria

January 11, 2007

First Posted (ESTIMATE)

January 12, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

January 21, 2016

Last Update Submitted That Met QC Criteria

January 20, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01 KI 0501

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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