Oral Human Papillomavirus Infection in HIV-infected Men

This study is currently recruiting participants. (see Contacts and Locations)

Verified January 2016 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: January 20, 2016

Last verified: January 2016

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

Drug Information available for: Human Papillomaviruses

U.S. FDA Resources

Further study details as provided by Deutsche Luft und Raumfahrt:

Primary Outcome Measures:

Spectrum of HPV types and associated clinical lesions [ Time Frame: swabs will be obtained approximately every 6 months ] [ Designated as safety issue: No ]


Estimated Enrollment:	500
Study Start Date:	March 2006
Estimated Study Completion Date:	January 2018
Estimated Primary Completion Date:	January 2017 (Final data collection date for primary outcome measure)

Intervention Details:

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 (Adult, Senior)
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:

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:

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


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:	January 20, 2016
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:


Infection Communicable Diseases HIV Infections Papillomavirus Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections	Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases DNA Virus Infections Tumor Virus Infections

ClinicalTrials.gov processed this record on September 23, 2016

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