Development of Serologic Assays for Human Herpes Virus-8

Status Completed

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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00395278
Study type	Observational
Source	National Institutes of Health Clinical Center (CC)
Contact
Status	Completed
Phase
Start date	October 30, 2006
Completion date	December 10, 2020

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT02135419` - Treatment in Preventing Anal Cancer in Patients With HIV and Anal High-Grade Lesions	Phase 3
Active, not recruiting	`NCT02663856` - My Smart Age With HIV: Smartphone Self-assessment of Frailty
Completed	`NCT02921516` - Growing Up: Intervening With HIV-Positive Adolescents in Resource-Poor Settings	N/A
Completed	`NCT02659306` - Metformin Immunotherapy in HIV Infection	Phase 1
Completed	`NCT02846402` - Impact of HIV Self-testing Among Female Sex Workers in Kampala, Uganda	N/A
Completed	`NCT02663869` - Aging With HIV at Younger vs Older Age: a Diverse Population With Distinct Comorbidity Profiles
Terminated	`NCT02743598` - Liraglutide for HIV-associated Neurocognitive Disorder	Phase 4
Completed	`NCT02564341` - Targeting Effective Analgesia in Clinics for HIV - Intervention	N/A
Active, not recruiting	`NCT02302950` - A Retrospective Analysis of Raltegravir Use in Minority HIV Infected Women in Houston, Texas	N/A
Completed	`NCT02269605` - Bryostatin-1 Effect on HIV-1 Latency and Reservoir in HIV-1 Infected Patients Receiving Antiretroviral Treatment	Phase 1
Terminated	`NCT02109224` - Ibrutinib in Treating Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma in Patients With HIV Infection	Phase 1
Completed	`NCT01830595` - Lactoferrin Treatment in HIV Patients	Phase 2
Completed	`NCT01852942` - Reversing Tissue Fibrosis to Improve Immune Reconstitution in HIV	Phase 2
Terminated	`NCT01902186` - Bone Mineral Density Changes in HIV-positive Females With Osteopenia Switching to Raltegravir	Phase 4
Completed	`NCT02525146` - Birmingham Access to Care Study	N/A
Completed	`NCT02527135` - Text Messaging to Improve HIV Testing Among Young Women in Kenya	N/A
Completed	`NCT02118168` - Observational Study for the Extended Follow-up of the Patients Enrolled in the Therapeutic Clinical Trial ISS T-002	N/A
Completed	`NCT01946217` - Factors Affecting Patient Participation in AIDS Malignancy Clinical Trials Consortium Clinical Trials	N/A
Active, not recruiting	`NCT02602418` - Neural Correlates of Working Memory Training for HIV Patients	N/A
Completed	`NCT01680094` - Safety and Effect of The HDAC Inhibitor Panobinostat on HIV-1 Expression in Patients on Suppressive HAART	Phase 1/Phase 2