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This study has been withdrawn prior to enrollment.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:

MedlinePlus related topics: HIV/AIDS Hepatitis Hepatitis A Hepatitis C

U.S. FDA Resources

Further study details as provided by Arash Grakoui PhD, 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 ]

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 ]

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 ]


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)
Sexes Eligible for Study:	All
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:

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


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

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

ClinicalTrials.gov processed this record on August 16, 2017

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