drugset / Trial / NCT00122616
Efficacy of Pegylated Interferon on Liver Fibrosis in Co-infected Patient With HIV and Hepatitis C
Phase 3
Completed
52 enrolled
French National Agency for Research on AIDS and Viral Hepatitis
Hoffmann-La Roche · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The aim of this study is to prove the efficacy of peginterferon in HIV infected patients with liver disease caused by hepatitis C virus (HCV) when the treatment to eradicate the virus failed. This scientific proof needs a comparative study to be done including two groups of patients randomly allocated: one with the treatment (peginterferon) and the other without any treatment against HCV with a duration of 2 years. To conclude, two liver biopsies are needed; one before the study and a second 2 years after.
Timeline
- Start
- 2003-11
- Primary completion
- 2009-03
- Completion
- 2009-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Peginterferon alfa-2a | Protein / enzyme biologic | 180 ug | Subcutaneous |
| Comparator | Ribavirin | Small molecule | 1000 mg | Oral |
| Comparator | Ribavirin | Small molecule | 1200 mg | Oral |