Generation of Anti-HCV Antibodies From Bone Marrow: Defining the Repertoire of Immune Response to HCV Quasispecies

This study has been completed.

Sponsor:

Information provided by:

National Institutes of Health Clinical Center (CC)

ClinicalTrials.gov Identifier:

NCT00004851

First received: March 2, 2000

Last updated: March 3, 2008

Last verified: March 2000

History of Changes

Tracking Information
First Received Date ^ICMJE	March 2, 2000
Last Updated Date	March 3, 2008
Start Date ^ICMJE	April 1999
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00004851 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Generation of Anti-HCV Antibodies From Bone Marrow: Defining the Repertoire of Immune Response to HCV Quasispecies
Official Title ^ICMJE	Generation of Anti-HCV Antibodies From Bone Marrow: Defining the Repertoire of Immune Response to HCV Quasispecies
Brief Summary	To generate a library of genes that reflect the entirety of antibody responses to hepatitis C virus (HCV) made during the 20-year course of HCV infection in a single patient (WH) whose viral quasispecies has been extensively characterized. In addition to characterizing the sequential events in antibody formation and their relationship to the changing pattern of viral quasispecies, we hope to identify neutralizing antibodies and the epitopes to which they are directed. Ultimately we seek to gain insight into the host mechanisms that suppress viral replication and to translate this to therapeutic and preventive modalities.
Detailed Description	To generate a library of genes that reflect the entirety of antibody responses to hepatitis C virus (HCV) made during the 20-year course of HCV infection in a single patient (WH) whose viral quasispecies has been extensively characterized. In addition to characterizing the sequential events in antibody formation and their relationship to the changing pattern of viral quasispecies, we hope to identify neutralizing antibodies and the epitopes to which they are directed. Ultimately we seek to gain insight into the host mechanisms that suppress viral replication and to translate this to therapeutic and preventive modalities.
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Not Provided
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Not Provided
Study Population	Not Provided
Condition ^ICMJE	Hepatitis C
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Not Provided
Publications *	Feinstone SM, Alter HJ, Dienes HP, Shimizu Y, Popper H, Blackmore D, Sly D, London WT, Purcell RH. Non-A, non-B hepatitis in chimpanzees and marmosets. J Infect Dis. 1981 Dec;144(6):588-98. Hijikata M, Shimizu YK, Kato H, Iwamoto A, Shih JW, Alter HJ, Purcell RH, Yoshikura H. Equilibrium centrifugation studies of hepatitis C virus: evidence for circulating immune complexes. J Virol. 1993 Apr;67(4):1953-8. Shimizu YK, Hijikata M, Iwamoto A, Alter HJ, Purcell RH, Yoshikura H. Neutralizing antibodies against hepatitis C virus and the emergence of neutralization escape mutant viruses. J Virol. 1994 Mar;68(3):1494-500.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	1
Completion Date	May 2001
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Persistent infection with mild hepatitis that is non-progressive.
Gender	Both
Ages	Not Provided
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00004851
Other Study ID Numbers ^ICMJE	990090, 99-CC-0090
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	National Institutes of Health Clinical Center (CC)
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	National Institutes of Health Clinical Center (CC)
Verification Date	March 2000
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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