- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00165919
Immune Response to Hepatitis C Virus
Immunologic Determinants of Hepatitis C Virus Infection Resolution or Persistence
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
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.
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
HCV+
No group or cohort; not a clinical trial
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
This is NOT a clinical trial; thus no outcomes. Specimens from human subjects taken at clinical site and sent unidentified to laboratory for assays.
Tidsramme: no outcomes measured
|
no outcomes measured
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
This is NOT a clinical trial; thus no outcomes. Specimens from human subjects taken at clinical site and sent unidentified to laboratory for assays.
Tidsramme: no outcomes to measure
|
no outcomes to measure
|
Andre resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
This is NOT a clinical trial; thus no outcomes. Specimens from human subjects taken at clinical site and sent unidentified to laboratory for assays.
Tidsramme: no outcomes measured
|
no outcomes measured
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Arash Grakoui, Ph.D., Emory University
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1358-2004
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