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An Open-Label, Randomized Study to Determine the Impact of Antiretroviral Treatment in HCV/HIV-Coinfected Subjects With High CD4+ Cell Count on the Efficacy of Hepatitis C Treatment With Pegylated Interferon Alfa-2A and Ribavirin
A significant proportion of HIV infected people in the U.S. are also infected with hepatitis C virus (HCV). The purpose of this study is to determine the effects of anti-HIV therapy on treatment of HCV with pegylated interferon alfa-2a and ribavirin (PEG/RBV).
Details
| Lead sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Phase | NA |
| Status | COMPLETED |
| Enrolment | 2 |
| Completion | 2007-01 |
Conditions
- HIV Infections
- Hepatitis C
Interventions
- Efavirenz
- Lamivudine
- Lopinavir/ritonavir
- Pegylated interferon alfa-2a
- Ribavirin
- Tenofovir disoproxil fumarate
Primary outcomes
- HCV viral load at least 2 log10 less than baseline or below the limit of detection by quantitative assay at 12 weeks after the start of HCV treatment (early virologic response)
- HIV and/or HCV treatment-limiting or Grade 4 or higher signs and symptoms and laboratory values
Countries
United States