Immune Response to Hepatitis C Virus
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Purpose
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.
| Study Type: | Observational |
| Official Title: | Immunologic Determinants of Hepatitis C Virus Infection Resolution or Persistence |
| Enrollment: | 0 |
| Study Start Date: | September 2005 |
| Primary Completion Date: | September 2005 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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.
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
Contacts and Locations More Information
Publications:
| Responsible Party: | Arash Grakoui PhD, Associate Professor, Emory University |
| ClinicalTrials.gov Identifier: | NCT00165919 History of Changes |
| Other Study ID Numbers: | 1358-2004 |
| Study First Received: | September 9, 2005 |
| Last Updated: | May 23, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Emory University:
|
Hepatitis C HIV Immunopathogenesis HIV-1 |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Hepatitis Hepatitis A Hepatitis C Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Enterovirus Infections Picornaviridae Infections Flaviviridae Infections |
ClinicalTrials.gov processed this record on March 03, 2013
