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Immune Response to Hepatitis C Virus

Primary Purpose

Hepatitis C, HIV Infections

Status
Withdrawn
Phase
Locations
Study Type
Observational
Intervention
None. Not a clinical trial. Specimens taken for basic research in laboratory.
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Hepatitis C focused on measuring Hepatitis C, HIV, Immunopathogenesis, HIV-1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Arm Label

    HCV+

    Arm Description

    No group or cohort; not a clinical trial

    Outcomes

    Primary Outcome Measures

    This is NOT a clinical trial; thus no outcomes. Specimens from human subjects taken at clinical site and sent unidentified to laboratory for assays.

    Secondary Outcome Measures

    This is NOT a clinical trial; thus no outcomes. Specimens from human subjects taken at clinical site and sent unidentified to laboratory for assays.

    Full Information

    First Posted
    September 9, 2005
    Last Updated
    November 12, 2013
    Sponsor
    Emory University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00165919
    Brief Title
    Immune Response to Hepatitis C Virus
    Official Title
    Immunologic Determinants of Hepatitis C Virus Infection Resolution or Persistence
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    November 2013
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Not a clinical trial; human specimens from treatment site for basic research.
    Study Start Date
    September 2005 (undefined)
    Primary Completion Date
    September 2005 (Actual)
    Study Completion Date
    September 2005 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Emory University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatitis C, HIV Infections
    Keywords
    Hepatitis C, HIV, Immunopathogenesis, HIV-1

    7. Study Design

    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    HCV+
    Arm Description
    No group or cohort; not a clinical trial
    Intervention Type
    Other
    Intervention Name(s)
    None. Not a clinical trial. Specimens taken for basic research in laboratory.
    Primary Outcome Measure Information:
    Title
    This is NOT a clinical trial; thus no outcomes. Specimens from human subjects taken at clinical site and sent unidentified to laboratory for assays.
    Time Frame
    no outcomes measured
    Secondary Outcome Measure Information:
    Title
    This is NOT a clinical trial; thus no outcomes. Specimens from human subjects taken at clinical site and sent unidentified to laboratory for assays.
    Time Frame
    no outcomes to measure
    Other Pre-specified Outcome Measures:
    Title
    This is NOT a clinical trial; thus no outcomes. Specimens from human subjects taken at clinical site and sent unidentified to laboratory for assays.
    Time Frame
    no outcomes measured

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Study Population Description
    This is not a clinical trial, but rather a basic science study using blinded human specimens. Individuals with HCV infection will be identified for enrollment into our study by our clinical collaborators at the Crawford Long Infectious Diseases Clinic-Emory University. Control individuals with no prior exposure to HCV will be identified and enrolled both from the Crawford Long clinics and from the investigative donor pool at the Emory Vaccine Center. Inclusion in the current study will be limited to individuals with HCV genotype 1 infection as well as uninfected normal controls as determined by antibody and viral load measurements.
    Sampling Method
    Non-Probability Sample
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Arash Grakoui, Ph.D.
    Organizational Affiliation
    Emory University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    11118387
    Citation
    Spellberg B, Edwards JE Jr. Type 1/Type 2 immunity in infectious diseases. Clin Infect Dis. 2001 Jan;32(1):76-102. doi: 10.1086/317537. Epub 2000 Dec 15.
    Results Reference
    background

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    Immune Response to Hepatitis C Virus

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