Immune Response to Hepatitis C Virus
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Hepatitis C HIV Infections | Other: None. Not a clinical trial. Specimens taken for basic research in laboratory. | Phase 1 |
| Study Type: | Observational |
| Official Title: | Immunologic Determinants of Hepatitis C Virus Infection Resolution or Persistence |
- 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 ]
- 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 ]
- 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 ]
| Enrollment: | 0 |
| Study Start Date: | September 2005 |
| Study Completion Date: | September 2005 |
| Primary Completion Date: | September 2005 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
HCV+
No group or cohort; not a clinical trial
|
Other: None. Not a clinical trial. Specimens taken for basic research in laboratory. |
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.
Eligibility
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00165919
| Principal Investigator: | Arash Grakoui, Ph.D. | Emory University |
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 |
| First Submitted: | September 9, 2005 |
| First Posted: | September 14, 2005 |
| Last Update Posted: | November 13, 2013 |
| Last Verified: | November 2013 |
Keywords provided by Arash Grakoui PhD, Emory University:
|
Hepatitis C HIV Immunopathogenesis HIV-1 |
Additional relevant MeSH terms:
|
Infection Hepatitis Hepatitis A Hepatitis C HIV Infections Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections |
Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Lentivirus Infections Retroviridae Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |