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Sponsored by: |
University of Texas Southwestern Medical Center |
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Information provided by: | University of Texas Southwestern Medical Center |
ClinicalTrials.gov Identifier: | NCT00703560 |
The purpose of this study is to evaluate what happens to hepatitis C virus in response to treatment with pegylated interferon and ribavirin in patients with HCV compared to those with HIV and HCV.
This research is being done to help us identify how the composition of HCV changes with interferon in different populations. We will examine how quickly HCV is cleared from your body and what factors may influence that clearance. This information may help us find better treatments for HCV.
Condition |
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Hepatitis C |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Molecular Basis of Interferon Response in HCV |
serum, peripheral blood mononuclear cells
Estimated Enrollment: | 72 |
Study Start Date: | September 2005 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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1
HIV and HCV genotype 1 coinfected (any race)
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2
HCV genotype 1 (any race)
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All patients who participate in this study will have frequent blood drawn in order to measure how quickly HCV virus declines. Pegylated interferon and ribavirin are not provided by the study, but will be obtained as part of standard of care treatment for hepatitis C. Participants must be willing to spend 48 hours in the hospital for frequent blood draws. They will be compensated for their time.
All patients must be HCV genotype 1. All patients must have a liver biopsy prior to enrollment into study. (This is not provided by the study).
HIV-infected patients must have a CD4 cell count>300. If HIV-infected and on antiretroviral therapy for HIV, they must be on a stable regimen for 12 weeks. The HIV regimen can not include didanosine (Videx).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patients with HCV genotype 1 with or without HIV-infection of any race.
Inclusion Criteria:
For HIV infected patients:
Exclusion Criteria:
Additional Exclusion for HIV-infected:
Contact: Nancy Liston, MPH | 214-645-6189 | nancy.liston@utsouthwestern.edu |
United States, Texas | |
UT Southwestern Medical Center | Recruiting |
Dallas, Texas, United States, 75390 |
Principal Investigator: | Mamta K. Jain, MD, MPH | UT Southwestern Medical Center |
Responsible Party: | UT Southwestern Medical Center ( Mamta K. Jain/ Prinicipal Investigator ) |
Study ID Numbers: | 102005-009, K23 AI065630 |
Study First Received: | June 19, 2008 |
Last Updated: | July 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00703560 |
Health Authority: | United States: Federal Government; United States: Institutional Review Board |
HCV Genotype 1 HIV co-infection viral kinetics |
HCV quasi-species Hepatitis C genotype 1 HIV Infections |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases HIV Infections |
Interferons Acquired Immunodeficiency Syndrome Hepatitis, Viral, Human Hepatitis C |
RNA Virus Infections Flaviviridae Infections |