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Immune Response to Hepatitis C Virus

NCT ID: NCT00165919

Last Updated: 2013-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2005-09-30

Study Completion Date

2005-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hepatitis C HIV Infections

Keywords

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Hepatitis C HIV Immunopathogenesis HIV-1

Study Groups

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HCV+

No group or cohort; not a clinical trial

None. Not a clinical trial. Specimens taken for basic research in laboratory.

Intervention Type OTHER

Interventions

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None. Not a clinical trial. Specimens taken for basic research in laboratory.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* HCV infected and uninfected (controls)
* Women
* Minorities

Exclusion Criteria

* Children
* Individuals who cannot or will not provide informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Emory University

OTHER

Sponsor Role lead

Responsible Party

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Arash Grakoui PhD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Arash Grakoui, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Emory University

Countries

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United States

References

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Spellberg B, Edwards JE Jr. Type 1/Type 2 immunity in infectious diseases. Clin Infect Dis. 2001 Jan;32(1):76-102. doi: 10.1086/317537. Epub 2000 Dec 15.

Reference Type BACKGROUND
PMID: 11118387 (View on PubMed)

Other Identifiers

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1358-2004

Identifier Type: -

Identifier Source: org_study_id