Hepatitis C Virus and the Humoral Immune System

This study has been completed.
Sponsor:
Collaborators:
New York Presbyterian Hospital
Information provided by (Responsible Party):
Rockefeller University
ClinicalTrials.gov Identifier:
NCT00219999
First received: September 19, 2005
Last updated: August 6, 2013
Last verified: August 2013
  Purpose

The purpose of this study is to measure specific chemokines, antibodies, and antibody-producing B cells in the blood of patients with hepatitis C virus (HCV) infection. Our hypothesis is that changes in chemokine levels affect the development of an effective immune response against HCV.


Condition
Hepatitis C Virus

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Hepatitis C Virus and the Humoral Immune System

Resource links provided by NLM:


Further study details as provided by Rockefeller University:

Primary Outcome Measures:
  • Define the relationships between HCV infection, B cell phenotype, and B cell function [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Define the relationships between HCV infection, B cell phenotype, and B cell function


Biospecimen Retention:   Samples With DNA

whole blood


Enrollment: 161
Study Start Date: September 2001
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
HCV infection
current HCV infection, including intravenous drug users
cryoglobulinemia
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
normal, healthy volunteers

Detailed Description:

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:

  1. 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.
  2. 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

primary care clinics of doctors at NYPH and the NYC metropolitan area

Criteria

Inclusion Criteria:

  • Healthy volunteers, no liver disease
  • Chronic infection with hepatitis C virus
  • Other chronic liver disease unrelated to hepatitis C virus
  • Subjects in all groups must have sufficiently healthy veins to allow blood collection.

Exclusion Criteria:

  • Any medical condition that, in the opinion of the investigators, precludes the patient's participation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00219999

Locations
United States, New York
Rockefeller University Hosital
New York, New York, United States, 10021
Sponsors and Collaborators
Rockefeller University
New York Presbyterian Hospital
Investigators
Principal Investigator: Lynn B Dustin, PHD Rockefeller University
  More Information

No publications provided

Responsible Party: Rockefeller University
ClinicalTrials.gov Identifier: NCT00219999     History of Changes
Other Study ID Numbers: LDU-0437, R01AI60561
Study First Received: September 19, 2005
Last Updated: August 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Rockefeller University:
Hepatitis
Hepacivirus
B Lymphocytes
Chemokines
Antibodies

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on April 21, 2014