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| ID | Type | Description | Link |
|---|---|---|---|
| K23AI065630 | U.S. NIH Grant/Contract | View source |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | HIV and HCV genotype 1 coinfected (any race) | ||
| 2 | HCV genotype 1 (any race) |
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| Measure | Description | Time Frame |
|---|---|---|
| Comparison of interferon effectiveness (as measured by epsilon) in HIV/HCV to HCV alone and African American to Caucasians. | 72 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| SVR rate in HIV/HCV vs. HCV and African Americans vs. Caucasians | 72 weeks | |
| Comparison of HCV quasi-species diversity | 72 weeks |
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Inclusion Criteria:
For HIV infected patients:
Exclusion Criteria:
Additional Exclusion for HIV-infected:
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Patients with HCV genotype 1 with or without HIV-infection of any race.
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| Name | Affiliation | Role |
|---|---|---|
| Mamta K. Jain, MD, MPH | University of Texas Southwestern Medical Center | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23183434 | Derived | Jain MK, Pasipanodya JG, Alder L, Lee WM, Gumbo T. Pegylated interferon fractal pharmacokinetics: individualized dosing for hepatitis C virus infection. Antimicrob Agents Chemother. 2013 Mar;57(3):1115-20. doi: 10.1128/AAC.02208-12. Epub 2012 Nov 26. |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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serum, peripheral blood mononuclear cells
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |