Immune Response to Hepatitis C Virus

Study Overview
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Brief Summary
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The purpose of the study is to investigate the immune response to hepatitis C virus to determine why some people clear the virus and others develop chronic infection. Changes in immune response once hepatitis C therapy is begun will also be examined. If patients are also HIV+, the effect of antiretroviral therapy on the recovery of hepatitis C immunity will be investigated.

Detailed Description
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We will analyze the peripheral (blood) and intrahepatic (liver) immune response in hepatitis C infection in patients with clear hepatitis C infection and those who develop chronic infection. We hope to determine immune responses that are important for eliminating the infection. Currently, the treatments for hepatitis C are not effective for everyone. For those patients enrolled who begin hepatitis C treatment, we will evaluate the immune system of people who respond compared to those who do not respond. If the patient is HIV positive, the change in hepatitis C immune response once various HIV medicines (antiretrovirals) are started will also be examined. Any treatment for hepatitis C or HIV will be determined by the patient's primary physician and will not be affected by enrollment in the study. Blood samples of  70 cc will be obtained no more than once per week. Patients who begin hepatitis C therapy or antiretroviral therapy if HIV coinfected will provide serial specimens for examination. Patients who undergo liver biopsy as a part of their routine hepatitis care will provide a sample for further studies of the immune response to see if it is different in the liver compared to the blood.

Official Title
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Immunologic Determinants of Hepatitis C Virus Infection Resolution or Persistence

Conditions
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Hepatitis C, HIV Infections

Intervention / Treatment
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* Other: None. Not a clinical trial. Specimens taken for basic research in laboratory.


Participation Criteria
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Eligibility Criteria
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This is not a clinical trial. Inclusion Criteria HCV infected and uninfected (controls) Women Minorities Exclusion Criteria Children Individuals who cannot or will not provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HCV+<br>No group or cohort; not a clinical trial | Other: None. Not a clinical trial. Specimens taken for basic research in laboratory.<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| This is NOT a clinical trial; thus no outcomes. Specimens from human subjects taken at clinical site and sent unidentified to laboratory for assays. |  | no outcomes measured | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| This is NOT a clinical trial; thus no outcomes. Specimens from human subjects taken at clinical site and sent unidentified to laboratory for assays. |  | no outcomes to measure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis C, HIV, Immunopathogenesis, HIV-1