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Development of Serologic Assays for Human Herpes Virus-8

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00395278
First received: October 31, 2006
Last updated: April 20, 2017
Last verified: March 23, 2017
October 31, 2006
April 20, 2017
October 27, 2006
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Complete list of historical versions of study NCT00395278 on ClinicalTrials.gov Archive Site
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Development of Serologic Assays for Human Herpes Virus-8
Development of Serologic Assays for Human Herpes Virus-8
Dr. Burbelo and colleagues have developed a technique for rapidly and quantitatively detecting antibody responses in sera to a variety of pathogens using recombinant proteins. We would like to apply this technique to develop an assay for detecting antibodies to HHV-8 (KSHV, the etiologic agents of Kaposi's sarcoma, an AIDS-defining condition). We initially plan to examine samples from patients with Kaposi's sarcoma, since all those patients are almost certainly infected with HHV-8. We are thus using samples from patients with previously diagnosed Kaposi's sarcoma. The samples in question are stored at the NCI FCRF repository operated by SAIC Frederick or in Rockville, MD.

Our colleagues have developed a technique for rapidly and quantitatively detecting antibody responses in sera to a variety of antigens using recombinant proteins. We would like to apply this technique to develop an assay for detecting antibodies to HHV- 8 (KSHV, the etiologic agent of Kaposi s sarcoma, an AIDS-defining condition). In addition we would like to potentially measure antibody responses to HIV, other infectious agents, and human antigens, to see if antibodies (or high antibody titers) to these antigens are associated with Kaposi s sarcoma or HIV infection. We initially plan to examine samples from patients with Kaposi s sarcoma, since all those patients are almost certainly infected with HHV-8. We would subsequently plan to examine samples from HIV positive and HIV negative patients without known Kaposi s sarcoma. We are thus requesting permission to use samples from patients with and without previously diagnosed Kaposi's Sarcoma. In addition to antibody testing, we would also like to examine these samples for evidence of infection with other infectious agents, such as newly identified or unknown viruses, using techniques such as PCR or deep

sequencing.

Observational
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Herpesvirus 8, Human
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
429
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  • Data analysis only
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00395278
999907018
07-CC-N018
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National Institutes of Health Clinical Center (CC)
National Institutes of Health Clinical Center (CC)
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Principal Investigator: Joseph A Kovacs, M.D. National Institutes of Health Clinical Center (CC)
National Institutes of Health Clinical Center (CC)
March 23, 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP