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Immune Response to Hepatitis C Virus

This study has been withdrawn prior to enrollment.
(Not a clinical trial; human specimens from treatment site for basic research.)
Sponsor:
Information provided by (Responsible Party):
Arash Grakoui PhD, Emory University
ClinicalTrials.gov Identifier:
NCT00165919
First received: September 9, 2005
Last updated: November 12, 2013
Last verified: November 2013
History of Changes
  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.

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Emory University:

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. [ Time Frame: no outcomes measured ] [ Designated as safety issue: No ]

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. [ Time Frame: no outcomes to measure ] [ Designated as safety issue: No ]

Other 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. [ Time Frame: no outcomes measured ] [ Designated as safety issue: No ]
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
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00165919

Sponsors and Collaborators
Emory University
Investigators
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 
Study First Received: September 9, 2005
Last Updated: November 12, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by 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

ClinicalTrials.gov processed this record on September 27, 2016