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| Sponsored by: |
Emory University |
|---|---|
| Information provided by: | Emory University |
| ClinicalTrials.gov Identifier: | NCT00165919 |
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 |
| Study Design: | Natural History, Longitudinal, Defined Population, Retrospective/Prospective Study |
| Official Title: | Immunologic Determinants of Hepatitis C Virus Infection Resolution or Persistence |
| Estimated Enrollment: | 200 |
| Study Start Date: | January 2005 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Kimberly A Workowski, MD | 404-686-8114 | kworkow@emory.edu |
| United States, Georgia | |
| Emory Crawford Long Infectious Disease Clinic | Recruiting |
| Atlanta, Georgia, United States, 30306 | |
| Contact: Kimberly A Workowski, MD 404-686-8114 kworkow@emory.edu | |
| Principal Investigator: Kimberly A Workowski, MD | |
| Sub-Investigator: Helmut Albrecht, MD | |
| Sub-Investigator: James Steinberg, MD | |
| Principal Investigator: | Arash Grakoui, PhD | Emory University |
More Information
| Study ID Numbers: | 1358-2004 |
| Study First Received: | September 9, 2005 |
| Last Updated: | October 20, 2005 |
| ClinicalTrials.gov Identifier: | NCT00165919 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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Hepatitis C HIV Immunopathogenesis HIV-1 |
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Virus Diseases Hepatitis Liver Diseases Sexually Transmitted Diseases, Viral Digestive System Diseases HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Hepatitis, Viral, Human Hepatitis C Retroviridae Infections Immunologic Deficiency Syndromes |
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Communicable Diseases Liver Diseases RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Flaviviridae Infections Immune System Diseases Acquired Immunodeficiency Syndrome Hepatitis, Viral, Human Infection |
Immunologic Deficiency Syndromes Hepatitis Virus Diseases Digestive System Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections Hepatitis C Retroviridae Infections |
