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Leukapheresis for Research on HCV-Coinfected Patients
This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), June 2009
First Received: January 21, 2004   Last Updated: August 24, 2009   History of Changes
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00076427
  Purpose

This study will collect quantities of white blood cells from patients infected with the hepatitis C virus (HCV) for research on the interactions between HCV and the human immunodeficiency virus (HIV) in people infected with both of these agents. Several studies have shown that infection with HIV adversely affects liver disease due to HCV.

Patients 18 years of age and older who are infected with both HCV and HIV or with HCV alone may be eligible for this study. Candidates must not have liver failure and must not be undergoing treatment for HCV at the time of enrollment.

Participants will undergo leukapheresis to collect white blood cells. This procedure allows collection of larger numbers of cells than would be possible with simple blood drawing. For the procedure, blood is removed through a needle in the vein of one arm and spun in a machine that separates the blood into its components. The white cells are extracted and the rest of the blood is re-infused through the same needle or through a needle in the other arm. The procedure takes approximately 1-3 hours, depending on the amount of white cells being collected. A maximum of three leukapheresis procedures are done. If additional procedures are required, the patient will sign a new consent form. Procedures will be limited to no more than three times a year, or once every 4 months.

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Condition
Hepatitis C
HIV Infections

Study Type: Observational
Official Title: Evaluation of Clinical, Virologic and Immunologic Factors That Contribute to the Pathogenesis of Chronic Hepatitis C and Its Complications

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 150
Study Start Date: January 2004
Estimated Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Detailed Description:

HCV infection is known to cause morbidity and mortality especially among those who are coinfected with HIV. The underlying immunopathogenesis of persistence of HCV infection, progression of liver disease and interactions with HIV are not yet clearly understood. A clear understanding of the immune correlates of protection against HCV would definitely be important in development of a vaccine for HCV. HCV infected individuals who are also coinfected with HIV have more rapid progression of liver disease, abnormal diagnostic serologies, higher levels of HCV viremia and markedly lower levels of therapeutic responses to the standard combination therapy with peginterferon and ribavirin. This study will recruit individuals who are coinfected with both HIV and HCV as well as those who are monoinfected with HCV. The study will require that patients be apheresed several times after enrollment. Apheresis will be necessary in order to obtain sufficient cells to pursue the following objectives: delineating B cell response to CD4+ T cell help, delineating CD8+ T factors associated with suppression of viral replication and normalization of immune function, and characterizing natural killer function relative to HCV disease and identify biomarkers for prgression of liver disease. The required number of mononuclear cells needed to perform these experiments can be easily and safely obtained using apheresis procedures in the Clinical Center Apheresis Unit. All patients will receive a liver biopsy (every 3 years for co-infected and every 5 years for mono-infected) subjects to assess the progression of liver disease performed at the NIH.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA - For Co-infected Patient:
  • Adult (18 years old or older) HIV-1-infected patient.
  • Positive ELISA and/or positive RNA test for HCV.
  • Positive ELISA and/or RNA test for HIV-1.
  • No evidence of liver failure
  • Not undergoing HCV therapy at the time of enrollment.
  • Willingness to give informed consent.
  • Willingness to be able to make follow up visits for apheresis at least once in the next 6 months.
  • They must be willing to undergo genetic testing and allow samples to be stored for future research.

INCLUSION CRITERIA - For Mono-infected Patient:

  • Positive serology and/or positive RNA test for HCV.
  • No evidence of liver failure
  • Not undergoing HCV therapy at the time of enrollment.
  • Willingness to give informed consent.
  • Willingness to be able to make follow up visits for apheresis at least once in the next 6 months.
  • Negative serology for HIV.
  • Adult (18 years old or older) patient.
  • They must be willing to undergo genetic testing and allow samples to be stored for future research.

EXCLUSION CRITERIA:

  • Pregnant women.
  • Severe anemia (hematocrit less than 28).
  • Severe thrombocytopenia platelet count less than 50,000 per micro liter.
  • Have any other condition, which the attending physician or Apheresis Unit staff considers a contraindication to the procedure
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00076427

Contacts
Contact: Patient Recruitment and Public Liaison Office (800) 411-1222 prpl@mail.cc.nih.gov
Contact: TTY 1-866-411-1010

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Additional Information:
Publications:
Study ID Numbers: 040086, 04-I-0086
Study First Received: January 21, 2004
Last Updated: August 24, 2009
ClinicalTrials.gov Identifier: NCT00076427     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Immunity
Liver
Apheresis
Cytokine
Virology
Hepatitis C
HCV
Hepatitis C co-infection

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
Liver Diseases
Immunologic Factors
Hepatitis, Chronic
Acquired Immunodeficiency Syndrome
Hepatitis, Viral, Human
Immunologic Deficiency Syndromes
Hepatitis
Virus Diseases
Digestive System Diseases
HIV Infections
Sexually Transmitted Diseases
Hepatitis C
Hepatitis C, Chronic
Retroviridae Infections

Additional relevant MeSH terms:
Liver Diseases
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Flaviviridae Infections
Immune System Diseases
Acquired Immunodeficiency Syndrome
Hepatitis, Viral, Human
Infection
Immunologic Deficiency Syndromes
Hepatitis
Virus Diseases
Digestive System Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Hepatitis C
Retroviridae Infections

ClinicalTrials.gov processed this record on August 30, 2009