Hepatitis C Virus and the Humoral Immune System

Hepatitis C Virus Clinical Trial

Official title:

Hepatitis C Virus and the Humoral Immune System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00219999
• Other study ID #: LDU-0437
• Secondary ID: R01AI060561
• Status: Completed
• Phase: N/A
• First received: September 19, 2005
• Last updated: August 6, 2013
• Start date: September 2001
• Est. completion date: May 2013

Study information

• Verified date: August 2013
• Source: Rockefeller University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Virus

Locations

Country	Name	City	State
United States	Rockefeller University Hosital	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Rockefeller University	National Institute of Allergy and Infectious Diseases (NIAID), New York Presbyterian Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Define the relationships between HCV infection, B cell phenotype, and B cell function	Define the relationships between HCV infection, B cell phenotype, and B cell function	5 years	No

External Links

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