Hepatitis C Virus and the Humoral Immune System
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|ClinicalTrials.gov Identifier: NCT00219999|
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : August 9, 2013
|Condition or disease|
|Hepatitis C Virus|
The long-term goal of our research is to understand why immune complexes (ICs) are produced in patients infected with HCV, and whether these complexes affect virus interaction with target cells. We have found that many patients infected with HCV have an increased frequency of circulating B cells, but no evidence that the increased B cells are activated of proliferating. One possible mechanism for such an increase would be a change in levels of chemokines that influence B cell localization and trafficking. Our studies are aimed at testing the following hypotheses:
- One hypothesis is that HCV infection results in increased levels of specific cytokines and chemokines that may affect the motility and localization of immature and mature B cells. An alternative model is that HCV infection leads to chronic antigenic stimulation of B lymphocytes, and that the abnormalities of B cell function associated with HCV infection reflect this chronic antigenic stimulation.
- A second hypothesis is that autoantibodies and immune complexes present in HCV patient serum contribute to the persistence and spread of viral infection.
To test these hypotheses, we are measuring levels of chemokines, the frequency of circulating B cells (mature resting B cells, mature activated B cells, memory B cells, and immature B cells), and the levels and components of ICs in the blood of HCV-infected patients. Controls include healthy volunteers and patients with chronic liver disease unrelated to HCV infection. No interventions in patient care are planned. When patients elect to undergo standard antiviral therapies under the supervision of their hepatologists, we will study the outcomes of therapy (no virologic response, partial or transient virologic response, sustained virologic response) to determine whether any of the observed alterations in chemokine levels, B cell frequency or activation, or immune complex levels correlate with the patient's response to antiviral therapy.
|Study Type :||Observational|
|Actual Enrollment :||161 participants|
|Official Title:||Hepatitis C Virus and the Humoral Immune System|
|Study Start Date :||September 2001|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||May 2013|
current HCV infection, including intravenous drug users
cryoglobulinemia and without HCV infection
chronic liver disease
chronic liver disease not due to hepatitis C virus infection
Sustained Virologic responders
successfully treated for HCV infection
normal, healthy volunteers
- Define the relationships between HCV infection, B cell phenotype, and B cell function [ Time Frame: 5 years ]Define the relationships between HCV infection, B cell phenotype, and B cell function
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00219999
|United States, New York|
|Rockefeller University Hosital|
|New York, New York, United States, 10021|
|Principal Investigator:||Lynn B Dustin, PHD||Rockefeller University|