Clinical trial NCT00165919: Immune Response to Hepatitis C Virus
Official title: Immunologic Determinants of Hepatitis C Virus Infection Resolution or Persistence
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Hepatitis C
HIV Infections
Keywords: Hepatitis C
HIV
Immunopathogenesis
HIV-1
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2005-09-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
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.

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.

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

Primary outcomes:
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.
timeFrame: no outcomes measured
Secondary outcomes:
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.
timeFrame: no outcomes to measure
Other outcomes:
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.
timeFrame: no outcomes measured
Locations:
Study officials:
affiliation: Emory University
name: Arash Grakoui, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.