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NCT00395278 Clinical Trial

Development of Serologic Assays for Human Herpes Virus-8

HIV Infection Clinical Trial

Official title:
Development of Serologic Assays for Human Herpes Virus-8

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00395278
Other study ID # 999907018
Secondary ID 07-CC-N018
Status Completed
Phase
First received
Last updated
Start date October 30, 2006
Est. completion date December 10, 2020

Study information
Verified date December 2020
Source National Institutes of Health Clinical Center (CC)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 394
Est. completion date December 10, 2020
Est. primary completion date December 10, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility - Data analysis only

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda Maryland

Sponsors (1)
Lead Sponsor Collaborator
National Institutes of Health Clinical Center (CC)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary HHV8 serology Direction of antibodies to HHV8 proteins At sample collection
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