Seroprevalence of Kaposi's Sarcoma Herpes Virus in the United States

This study has been completed.

Sponsor:

Information provided by:

National Institutes of Health Clinical Center (CC)

ClinicalTrials.gov Identifier:

NCT00026728

First received: November 14, 2001

Last updated: March 3, 2008

Last verified: December 2005

History of Changes

Tracking Information
First Received Date ^ICMJE	November 14, 2001
Last Updated Date	March 3, 2008
Start Date ^ICMJE	February 2001
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00026728 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Seroprevalence of Kaposi's Sarcoma Herpes Virus in the United States
Official Title ^ICMJE	The Seroprevalence of Kaposi's Sarcoma Herpesvirus in the United States
Brief Summary	This study will investigate patterns of Kaposi's sarcoma herpes virus (KSHV) in the United States and its potential impact on the U.S. population. KSHV is a newly discovered virus that is strongly associated with Kaposi's sarcoma and primary effusion lymphoma. The high prevalence of KS and KSHV among HIV-infected homosexual men suggests sexual contact as a primary mode of transmission. Reports of non-sexual transmission in parts of Africa and the Mediterranean where Kaposi's sarcoma is endemic, and the identification of viral DNA in saliva and other bodily fluids, however, indicate the virus is also transmitted non-sexually. This study will: Compare the prevalence of KSHV among different demographic groups in the United States Examine the association between KSHV and high risk behaviors such as drug use (marijuana and cocaine), sexual behavior (age at first sexual intercourse and number of sexual partners), and medical risk factors (herpes simplex virus II, hepatitis B and hepatitis C) Estimate the prevalence of KSHV in the United States. Data and blood samples for the study will be taken from the NHANES III survey. NHANES is a program of periodic surveys conducted by the Centers for Disease Control and Prevention's National Center for Health Statistics. The survey is designed to provide national estimates of health status for the United States non-institutionalized civilian population by means of household interviews, standardized physical examinations, and blood sample collection and testing. NHANES III-the seventh in a series of national examination studies-was conducted from 1988 to 1994. This study will use the HANES data to identify risks associated with a KSHV-positive blood test in the survey population. The study plans to include all 19,754 participants (67% of the 29,314 participants originally examined) for whom blood samples were collected and remain available.
Detailed Description	Kaposi sarcoma herpesvirus (KSHV) is the viral cause of Kaposi sarcoma. Although infection with this virus appears to be uncommon in the United States, the prevalence in the general population in uncertain, and routes for transmission are poorly characterized. This study makes use of questionnaire data and serum specimens obtained in the third National Health and Nutrition Survey (NHAnes III). Sera from 18,168 individuals in this study were tested for antibodies to the KSHV proteins K8.1 and LANA. We will use these measurements to estimate KSHV seroprevalence for the overall U.S. general population and for demographic subgroups. To characterize potential transmission routes, we will also examine whether KSHV seroprevalence is related to sexual activity and exposures to blood, as indicated by responses to questionnaire items and previous NHANES III measurements of markers of relevant viral infections.
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Not Provided
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Not Provided
Study Population	Not Provided
Condition ^ICMJE	Kaposi's Sarcoma Herpesviridae Infection
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Not Provided
Publications *	Huang YQ, Li JJ, Kaplan MH, Poiesz B, Katabira E, Zhang WC, Feiner D, Friedman-Kien AE. Human herpesvirus-like nucleic acid in various forms of Kaposi's sarcoma. Lancet. 1995 Mar 25;345(8952):759-61.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	20169
Completion Date	December 2005
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	No specific eligibility criteria was provided for this protocol.
Gender	Both
Ages	Not Provided
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00026728
Other Study ID Numbers ^ICMJE	010073, 01-C-0073
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	National Cancer Institute (NCI)
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	National Institutes of Health Clinical Center (CC)
Verification Date	December 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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