- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00165919
Immune Response to Hepatitis C Virus
Immunologic Determinants of Hepatitis C Virus Infection Resolution or Persistence
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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.
Description
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 Plan
How is the study designed?
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
HCV+
No group or cohort; not a clinical trial
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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.
Time Frame: no outcomes measured
|
no outcomes measured
|
Secondary Outcome Measures
Outcome Measure |
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.
Time Frame: no outcomes to measure
|
no outcomes to measure
|
Other Outcome Measures
Outcome Measure |
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.
Time Frame: no outcomes measured
|
no outcomes measured
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Arash Grakoui, Ph.D., Emory University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1358-2004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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