Study of Hepatitis C Virus (HCV) Viral Kinetics in HIV/HCV and HCV Patients (VK)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Molecular Basis of Interferon Response in HCV|
- Comparison of interferon effectiveness (as measured by epsilon) in HIV/HCV to HCV alone and African American to Caucasians. [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
- SVR rate in HIV/HCV vs. HCV and African Americans vs. Caucasians [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
- Comparison of HCV quasi-species diversity [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
serum, peripheral blood mononuclear cells
|Study Start Date:||September 2005|
|Study Completion Date:||January 2013|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
HIV and HCV genotype 1 coinfected (any race)
HCV genotype 1 (any race)
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00703560
|Principal Investigator:||Mamta K. Jain, MD, MPH||UT Southwestern Medical Center|