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Leukapheresis for Research on HCV-Coinfected Patients

NCT00076427 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 327

Last updated 2017-10-06

No results posted yet for this study

Summary

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.

Conditions

  • Hepatitis C
  • HIV Infections

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Colleen M Hadigan, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-14
Completion
2015-06-09

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00076427 on ClinicalTrials.gov