Protocol Number: 04-I-0086

Title:

Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research on HCV-Infected Patients

Number:

04-I-0086

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.

Sponsoring Institute:

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria:

INCLUSION CRITERIA:

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 or Child Pugh's score less than 6.

-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 4 months.

-They must be willing to undergo genetic testing and allow samples to be stored for future research.

Mono-infected patient:

-Positive serology and/or positive RNA test for HCV.

-No evidence of liver failure or Child Pugh's score less than 6.

-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 4 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

Special Instructions: Currently Not Provided

Keywords:

Immunity

Liver

Apheresis

Cytokine

Virology

Recruitment Keywords:

Hepatitis C

HCV

Hepatitis C co-infection

Conditions:

Hepatitis C

HIV Infections

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:

Gerlach JT, Diepolder HM, Jung MC, Gruener NH, Schraut WW, Zachoval R, Hoffmann R, Schirren CA, Santantonio T, Pape GR. Related Articles, Links Recurrence of hepatitis C virus after loss of virus-specific CD4(+) T-cell response in acute hepatitis C.

Gastroenterology. 1999 Oct; 117(4): 933-41. PMID: 10500077

Lechner F, Gruener NH, Urbani S, Uggeri J, Santantonio T, Kammer AR, Cerny A, Phillips R, Ferrari C, Pape GR, Klenerman P. Related Articles, Links CD8+ T lymphocyte responses are induced during acute hepatitis C virus infection but are not sustained. Eur J Immunol. 2000 Sep; 30(9): 2479-87.

PMID: 11009080

Thursz M, Yallop R, Goldin R, Trepo C, Thomas HC. Related Articles, Links Influence of MHC class II genotype on outcome of infection with hepatitis C virus. The HENCORE group. Hepatitis C European Network for Cooperative Research.

Lancet. 1999 Dec 18-25; 354(9196): 2119-24. PMID: 10609818

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