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Immune Response to Hepatitis C Virus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00165919
Recruitment Status : Withdrawn (Not a clinical trial; human specimens from treatment site for basic research.)
First Posted : September 14, 2005
Last Update Posted : November 13, 2013
Sponsor:
Information provided by (Responsible Party):
Arash Grakoui PhD, Emory University

Tracking Information
First Submitted Date September 9, 2005
First Posted Date September 14, 2005
Last Update Posted Date November 13, 2013
Study Start Date September 2005
Actual Primary Completion Date September 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 12, 2013)
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 ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: November 12, 2013)
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 ]
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: November 12, 2013)
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 ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Immune Response to Hepatitis C Virus
Official Title Immunologic Determinants of Hepatitis C Virus Infection Resolution or Persistence
Brief Summary 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

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.

Study Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.

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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: May 23, 2012)
0
Original Enrollment
 (submitted: September 9, 2005)
200
Actual Study Completion Date September 2005
Actual Primary Completion Date September 2005   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number NCT00165919
Other Study ID Numbers 1358-2004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Arash Grakoui PhD, Emory University
Study Sponsor Emory University
Collaborators Not Provided
Investigators
Principal Investigator: Arash Grakoui, Ph.D. Emory University
PRS Account Emory University
Verification Date November 2013