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临床试验/NCT00395278
NCT00395278已完成不适用

Development of Serologic Assays for Human Herpes Virus-8

National Institutes of Health Clinical Center (CC)1 个研究点 分布在 1 个国家目标入组 394 人开始时间: 2006年10月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
394
试验地点
1
主要终点
HHV8 serology

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

HHV8 serology

时间窗: At sample collection

Direction of antibodies to HHV8 proteins

次要结局

未报告次要终点

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (1)

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