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Withdrawn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Withdrawn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