Leukapheresis for Research on HCV-Coinfected Patients
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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.
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.
| Condition |
|---|
|
Hepatitis C HIV Infections |
| Study Type: | Observational |
| Official Title: | Evaluation of Clinical, Virologic and Immunologic Factors That Contribute to the Pathogenesis of Chronic Hepatitis C and Its Complications |
| Estimated Enrollment: | 500 |
| Study Start Date: | January 2004 |
Hepatitis C virus (HCV) infection is known to cause morbidity and mortality especially among those who are coinfected with Human Immunodeficiency virus (HIV). The underlying immunopathogenesis of HCV infection, progression of liver disease, and interactions with HIV are not yet clearly understood. A clear understanding of the immune correlates of protection against HCV would definitely be important in development of a vaccine for HCV. HCV infected individuals who are also coinfected with HIV have more rapid progression of liver disease, abnormal diagnostic serologies, higher levels of HCV viremia, and markedly lower levels of therapeutic responses to the standard combination therapy with peginterferon and ribavirin.
This study will recruit individuals who are coinfected with HIV and HCV as well as those who are monoinfected with HCV. The study will enroll 2 groups. Participants in the first group (hereafter referred to as Group 1) will consist of participants recruited for research and clinical related blood draws, leukapheresis, and liver biopsies. Participants in the second group (hereafter referred to as Group 2) will consist of participants with known or suspected HCV who need assistance with HCV diagnosis or treatment. The study will follow the natural history of HCV alone or HCV and HIV infections in both groups.
Participants in Group 1 will be apheresed or undergo blood draw several times after enrollment. Leukapheresis is necessary in order to obtain sufficient cells to pursue the following objectives: delineating B cell response to CD4+ T cell help, delineating CD8+ T factors associated with suppression of viral replication and normalization of immune function, characterizing natural killer function relative to HCV disease, and identifying biomarkers for progression of liver disease. The required number of mononuclear cells needed to perform these experiments can be easily and safely obtained using leukapheresis procedures in the Clinical Center Apheresis Unit. Participants who do not meet apheresis criteria may participate through routine blood draws to contribute to this research. All participants in Group 1 will also receive a liver biopsy at NIH (every 3 years for coinfected and every 5 years for monoinfected subjects) to assess the progression of liver disease.
Participants in Group 1 will be followed for 10 years. Participants in Group 2 will be evaluated for HCV infection or receive HCV treatment. They will be followed for up to one year.
Treatment plans for both groups will be in accordance with standard medical practice, and the number and length of additional visits and diagnostic evaluations will vary accordingly.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
- 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.
Contacts and Locations| Contact: Anita Kohli, M.D. | (301) 496-9320 | kohlia@mail.nih.gov |
| Contact: Shyamasundaran Kottilil, M.D. | (301) 435-0936 | skottilil@niaid.nih.gov |
| United States, District of Columbia | |
| Unity Health Care/Walker Jones | Recruiting |
| Washington, DC, District of Columbia, United States | |
| Family and Medical Counseling Service | Recruiting |
| Washington, DC, District of Columbia, United States | |
| Whitman Walker Clinic | Recruiting |
| Washington, DC, District of Columbia, United States | |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 prpl@mail.cc.nih.gov | |
| Principal Investigator: | Shyamasundaran Kottilil, M.D. | National Institute of Allergy and Infectious Diseases (NIAID) |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00076427 History of Changes |
| Other Study ID Numbers: | 040086, 04-I-0086 |
| Study First Received: | January 21, 2004 |
| Last Updated: | February 20, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institutes of Health Clinical Center (CC):
|
Immunity Liver Apheresis Cytokine |
Virology Hepatitis C HCV Hepatitis C co-infection |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Hepatitis Hepatitis A Hepatitis C Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes |
Immune System Diseases Slow Virus Diseases Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Enterovirus Infections Picornaviridae Infections Flaviviridae Infections Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on March 03, 2013
