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Study of the Immune Response to Hepatitis C Virus

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ClinicalTrials.gov Identifier: NCT00237432
Recruitment Status : Completed
First Posted : October 12, 2005
Last Update Posted : December 10, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to investigate the mechanism of a successful immune response to hepatitis C virus (HCV) infection. Currently, it is believed that the immune system is involved in responding to HCV infection, but how it is involved is not known. It is estimated that 30% of individuals infected with HCV are able to clear the virus without treatment, while 70% progress to chronic infectious. By studying the immune responses in these two populations, we, the researchers at Rockefeller University, hope to gain insight into the mechanisms of the immune response and develop new strategies for HCV therapy.

Condition or disease
Hepatitis C

Detailed Description:

Hepatitis C virus (HCV) infects approximately 200 million people worldwide. About 30% of infected individuals do not require treatment to clear the virus, but the remainder can become chronically infected with HCV. Both resolution and protection correlate with the presence of HCV-specific T cells responses. The researchers believe that dendritic cells (DCs) play a role in determining how T-cells respond to the virus. They believe that the virus is able to modify the function of these cells causing the inactivation of T cells that would otherwise react with the virus. By characterizing the phenotype and function of DCs in both the patients who spontaneously resolve the infection and patients who become chronically infected the investigators hope to learn more about the pathogenesis of HCV.

People interested in participating in this study will have a complete history and general medical examinations before beginning the study. Testing for communicable diseases, including hepatitis B, syphilis and HIV will be done. If a disease is found you will be informed and offered counseling.

Following the screening, you will have a procedure called leukapheresis, in which white blood cells are removed, but your own red blood cells are returned. The procedure takes approximately 3 hours and is similar to blood donation. The leukapheresis is done during a same day admission to the hospital by an outside blood collection company with trained nurses and certified equipment.

Some aspects of this study are experimental which means the fluid and cells collected will be studied and analyzed to determine more precisely how your body's immune system is responding to the virus. These tests are experimental in that they are not part of the usual routine care of patients.


Study Design

Study Type : Observational
Actual Enrollment : 11 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: HCV Pathogenesis and Dendritic Cell Immunobiology
Study Start Date : April 2003
Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Biospecimen Retention:   Samples With DNA
White blood cells

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with confirmed HCV infection recruited from the NYC metropolitan area
Criteria

Inclusion Criteria:

  • Patients with confirmed HCV infection based on serologic studies and/or plasma HCV titers
  • Individuals who have recovered from toxicity of any prior therapy and who have not had IFN-α and/or ribavirin therapy in the last 6 months
  • Performance status: Karnofsky 70-100%
  • Life expectancy of at least 12 months
  • Hematology laboratory results of:

    • WBC greater than 3,800/mm3
    • Absolute lymphocytes greater than 1,500/mm3
    • Platelets greater than 120,000/mm3
    • Hb at least 9.5 g/dl
    • INR < 1.5 IU

Exclusion Criteria:

  • Patients who are currently on immunotherapy
  • Individuals who are currently on antibiotics
  • Individuals who have had chemotherapy within the last year for other medical conditions
  • Individuals who have had corticosteroid treatment or radiotherapy within the last 4 weeks
  • Individuals infected with HIV, syphilis or hepatitis B or with other serious uncontrolled medical illness
  • People with currently active second malignancy other than non-melanoma skin cancer
  • No history of vasculitis
  • No alcohol or drug use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements
  • No patients with decompensated cirrhosis
  • No NYHA class III/IV status
  • No severe debilitating pulmonary disease
  • No psychiatric illness or social condition that, in the opinion of the investigator, would interfere with adherence to study requirements
Contacts and Locations

Information from the National Library of Medicine

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): NCT00237432


Locations
United States, New York
Rockefeller University Hospital
New York, New York, United States, 10021
Sponsors and Collaborators
Rockefeller University
Investigators
Principal Investigator: Charles M. Rice, PHD Rockefeller University
More Information

Responsible Party: Charles Rice, Rockefeller University
ClinicalTrials.gov Identifier: NCT00237432     History of Changes
Other Study ID Numbers: CRI-0505
First Posted: October 12, 2005    Key Record Dates
Last Update Posted: December 10, 2010
Last Verified: December 2010

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