Development of Serologic Assays for Human Herpes Virus-8

Sponsor

National Institutes of Health Clinical Center (CC) (NIH)

Overall Status

Completed

CT.gov ID

NCT00395278

Collaborator

(none)

394

Enrollment

Location

169.4

Actual Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Kaposi Sarcoma HIV Infection

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

394 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

Development of Serologic Assays for Human Herpes Virus-8

Actual Study Start Date :

Oct 30, 2006

Actual Primary Completion Date :

Dec 10, 2020

Actual Study Completion Date :

Dec 10, 2020

Arms and Interventions

Arm	Intervention/Treatment
HIV negative HIV negative without Kaposi sarcoma
HIV positive HIV positive without Kaposi sarcoma
HIV positive KS HIV positive with Kaposi sarcoma

Outcome Measures

Primary Outcome Measures

HHV8 serology [At sample collection]
Direction of antibodies to HHV8 proteins

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Data analysis only

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Institutes of Health Clinical Center, 9000 Rockville Pike	Bethesda	Maryland	United States	20892

Sponsors and Collaborators

National Institutes of Health Clinical Center (CC)

Investigators

Principal Investigator: Joseph A Kovacs, M.D., National Institutes of Health Clinical Center (CC)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

National Institutes of Health Clinical Center (CC)

ClinicalTrials.gov Identifier:

NCT00395278

Other Study ID Numbers:

999907018
07-CC-N018

First Posted:

Nov 2, 2006

Last Update Posted:

Dec 11, 2020

Last Verified:

Dec 1, 2020

Keywords provided by National Institutes of Health Clinical Center (CC)

Additional relevant MeSH terms:

Sarcoma, Kaposi

Sarcoma

Study Results

No Results Posted as of Dec 11, 2020