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| Sponsored by: |
Deutsche Luft und Raumfahrt |
|---|---|
| Information provided by: | Deutsche Luft und Raumfahrt |
| ClinicalTrials.gov Identifier: | NCT00421486 |
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: | Case Control, 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 |
| Estimated Enrollment: | 500 |
| Study Start Date: | March 2006 |
| Estimated Study Completion Date: | April 2010 |
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 |
HIV-infected men who have sex with men
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Alexander Kreuter, MD | 0049/234/5093439 | a.kreuter@derma.de |
| Germany, NRW | |
| 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 | |
| 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
| Responsible Party: | BMBF ( Kompetenznetz HIV/AIDS ) |
| Study ID Numbers: | 01 KI 0501 |
| Study First Received: | January 10, 2007 |
| Last Updated: | January 16, 2009 |
| ClinicalTrials.gov Identifier: | NCT00421486 History of Changes |
| Health Authority: | Germany: Ethics Commission |
|
Oral human papillomavirus infection HIV-infection High-risk HPV viral load |
Oral human papillomavirus infection in HIV-positive men Treatment Experienced Treatment Naive |
|
Sexually Transmitted Diseases, Viral Skin Diseases Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes Virus Diseases Skin Diseases, Infectious Warts |
HIV Seropositivity HIV Infections Sexually Transmitted Diseases Papillomavirus Infections DNA Virus Infections Retroviridae Infections |
|
Communicable Diseases RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Skin Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Tumor Virus Infections Infection Immunologic Deficiency Syndromes Skin Diseases, Viral |
Virus Diseases Skin Diseases, Infectious Neoplasms Warts HIV Infections Sexually Transmitted Diseases Lentivirus Infections DNA Virus Infections Papillomavirus Infections Retroviridae Infections |