Leukapheresis for Research on HCV-Coinfected Patients - Full Text View - ClinicalTrials.gov

NIAID Enrolling Patients with HIV and/or Hepatitis C for Clinical Research Study

Patients 18 years of age and older who are infected with the hepatitis C virus (HCV) alone or co-infected with the human immunodeficiency virus (HIV) may be eligible to participate in an NIAID clinical trial that researches the interactions between the HCV and HIV viruses. Study volunteers will undergo leukapheresis, a procedure for collecting a large number of white blood cells; patients who do not meet criteria for this procedure may contribute to this research through routine blood draws. This study is being conducted in the Washington, DC, metropolitan area.


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.

Purpose:
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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Leukapheresis for Research on HCV-Coinfected Patients - Full Text View - ClinicalTrials.gov