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This study has been withdrawn prior to enrollment.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

September 9, 2005
November 12, 2013
September 2005
September 2005   (final data collection date for primary outcome 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 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00165919 on ClinicalTrials.gov Archive Site
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 ]
Not Provided
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 ]
Not Provided
 
Immune Response to Hepatitis C Virus
Immunologic Determinants of Hepatitis C Virus Infection Resolution or Persistence

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.

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.

Observational
Not Provided
Not Provided
Not Provided
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.

  • Hepatitis C
  • HIV Infections
Other: None. Not a clinical trial. Specimens taken for basic research in laboratory.
None
HCV+
No group or cohort; not a clinical trial
Intervention: Other: None. Not a clinical trial. Specimens taken for basic research in laboratory.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
September 2005
September 2005   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00165919
1358-2004
No
Arash Grakoui PhD, Emory University
Emory University
Not Provided
Principal Investigator: Arash Grakoui, Ph.D. Emory University
Emory University
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP