Status:
COMPLETED
Leukapheresis for Research on HCV-Coinfected Patients
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Hepatitis C
HIV Infections
Eligibility:
All Genders
18+ years
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) ...
Detailed Description
Hepatitis C virus (HCV) and Hepatitis B (HBV) infection are known to cause morbidity and mortality especially among those who are coinfected with Human Immunodeficiency virus (HIV). HCV infected indiv...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA FOR BOTH GROUPS:
- 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
- INCLUSION CRITERIA FOR GROUP 1:
- Must be willing and able to make follow up visits for leukapheresis and blood draws at least once in the next 6 months
- INCLUSION CRITERIA FOR GROUP 2:
- Must be referred by a physician for the purposes of confirming HCV diagnosis, complications from HCV, or standard HCV treatment management.
- EXCLUSION CRITERIA FOR BOTH GROUPS
- Have any other condition, which the investigator considers a contraindication to study participation.
- EXCLUSION FOR GROUP 1:
- 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.
Exclusion
Key Trial Info
Start Date :
January 14 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 9 2015
Estimated Enrollment :
327 Patients enrolled
Trial Details
Trial ID
NCT00076427
Start Date
January 14 2004
End Date
June 9 2015
Last Update
October 6 2017
Active Locations (4)
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1
Family and Medical Counseling Service
Washington D.C., District of Columbia, United States
2
Unity Health Care/Walker Jones
Washington D.C., District of Columbia, United States
3
Whitman Walker Clinic
Washington D.C., District of Columbia, United States
4
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892