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NIAID HIV and Emerging Infectious Diseases Program

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HCVRES Study

Study Name

Evaluation of Clinical, Virologic and Immunologic Factors that Contribute to the Pathogenesis of Chronic Hepatitis C and Its Complications

Study Number

04-I-0086

Goal of Study

Determining how the immune system of some patients is able to control hepatitis C virus (HCV) is felt to be a very important step for designing vaccines and therapies for HCV. Several studies have shown that coinfection with human immunodeficiency virus (HIV) adversely affects liver disease due to HCV. Our laboratory is recruiting patients to further understand the mechanism (s) involved in the interactions between HCV and HIV and how such interactions affect the progression of one another. In addition, for purposes of comparison, patients who are infected with HCV alone are also being recruited.

Study Regimen

We will study how the immune system can control hepatitis virus through the use of the blood products (white blood cells and plasma) of patients in a number of tests. These blood products will be removed by a machine, which will remove the white cells from your blood and give the rest of the cells back to you. Approximately 60 patients will be enrolled in this study. This study will be for 3 years.

During this procedure, blood is removed through a needle in the vein of one arm, spun in a machine which permits separation of the desired blood component (usually white blood cells and plasma), and then the remainder is re-infused either through the same needle or through a needle in a vein in the other arm. An anticoagulant (a medication to prevent blood from clotting) is usually added to the blood while in the machine to prevent it from clotting during this processing. Volunteers will be compensated.

Eligibility Criteria 

  • Age 18 years or older with documented HCV infection
  • Willing to give informed consent for the storage of blood and HLA testing
  • Willing to return to the Clinical Center to donate blood at least once in the next 4 months
  • No evidence of liver failure
  • Not undergoing HCV treatment therapy at this time
  • Not pregnant
  • Not anemic (hematocrit <28)
  • Not thrombocytopenic (platelet count <50,000/micro liter)
  • Not have any other condition the Clinical Center or Apheresis Unit staff considers exclusionary for the study

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Last Updated July 25, 2013