Oral Human Papillomavirus Infection in HIV-infected Men

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00421486
• Other study ID #: 01 KI 0501
• Status: Recruiting
• Phase: N/A
• First received: January 10, 2007
• Last updated: January 20, 2016
• Start date: March 2006
• Est. completion date: January 2018

Study information

• Verified date: January 2016
• Source: Deutsche Luft und Raumfahrt
• Contact: Alexander Kreuter, MD
• Phone: 0049/234/5093439
• Email: a.kreuter[@]derma.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: January 2018
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• HIV-infected men who have sex with men

Exclusion Criteria:

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Communicable Diseases
• HIV Infections
• Infection
• Papillomavirus Infections

Intervention

Procedure:
• Oral swabs for HPV-typing and high-risk HPV-determination
Oral swabs for HPV-typing and high-risk HPV-determination

Locations

Country	Name	City	State
Germany	Department of Dermatology, Ruhr University Bochum	Bochum	NRW
Germany	Institute of Virology, University of Cologne	Köln	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Deutsche Luft und Raumfahrt

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spectrum of HPV types and associated clinical lesions		swabs will be obtained approximately every 6 months	No

External Links

•   Deutsches Kompetenznetz HIV/AIDS