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
|Condition or disease|
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 Type :||Observational|
|Actual Enrollment :||11 participants|
|Official Title:||HCV Pathogenesis and Dendritic Cell Immunobiology|
|Study Start Date :||April 2003|
|Actual Study Completion Date :||February 2008|
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
|United States, New York|
|Rockefeller University Hospital|
|New York, New York, United States, 10021|
|Principal Investigator:||Charles M. Rice, PHD||Rockefeller University|