Leukapheresis for Research on HCV-Coinfected Patients

NCT00076427 | Completed

• 2 other identifiers: 04008604-I-0086
• Study Type: observational
• Target: 327
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

Immunity; Liver; Apheresis; Cytokine; Virology; Hepatitis C; HCV; Hepatitis C co-infection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (18 years old or older)
• Either monoinfected with HCV or coinfected with HCV and HIV
• Willingness to give informed consent.
• Willing to undergo genetic testing
• Willing to have samples stored for future research.
• Must have a referring physician or clinic that will continue to provide medical care.
• Note: An HCV/HIV coinfected individual is defined as any individual with all the following: 1) Positive ELISA and western blot test for HIV, and 2) Positive serology and/or positive HCV RNA test; An HCV monoinfected individual is defined as any individual with all of the following: 1) Positive serology and/or positive HCV RNA test, and 2) Negative ELISA test for HIV
• Must be willing and able to make follow up visits for leukapheresis and blood draws at least once in the next 6 months
• Must be referred by a physician for the purposes of confirming HCV diagnosis, complications from HCV, or standard HCV treatment management.

You may not qualify if:

• Have any other condition, which the investigator considers a contraindication to study participation.
• Evidence of liver failure on liver biopsy, abdominal ultrasound, or liver function blood tests
• Receiving HCV therapy at the time of enrollment
• Platelet count \< 50,00 per mL
• Hematocrit \< 28 percent.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (4)

Family and Medical Counseling Service

Washington D.C., District of Columbia, United States

Location

Unity Health Care/Walker Jones

Washington D.C., District of Columbia, United States

Location

Whitman Walker Clinic

Washington D.C., District of Columbia, United States

Location

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Gerlach JT, Diepolder HM, Jung MC, Gruener NH, Schraut WW, Zachoval R, Hoffmann R, Schirren CA, Santantonio T, Pape GR. 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. doi: 10.1016/s0016-5085(99)70353-7.

  PMID: 10500077 BACKGROUND

• Lechner F, Gruener NH, Urbani S, Uggeri J, Santantonio T, Kammer AR, Cerny A, Phillips R, Ferrari C, Pape GR, Klenerman P. 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. doi: 10.1002/1521-4141(200009)30:93.0.CO;2-B.

  PMID: 11009080 BACKGROUND

• Thursz M, Yallop R, Goldin R, Trepo C, Thomas HC. 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. doi: 10.1016/s0140-6736(99)91443-5.

  PMID: 10609818 BACKGROUND

MeSH Terms

Conditions

Hepatitis C; HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Colleen M Hadigan, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2004
• First Posted: January 22, 2004
• Study Start: January 14, 2004
• Study Completion: June 9, 2015
• Last Updated: October 6, 2017

Record last verified: 2015-06-09

Locations

US (4)