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PEG-IFN vs IFN with Ribavirin for HIV/HCV Co-infection
NCT00008463Phase 2
Key facts
- Status
- Completed
- Start
- Nov 2000
- Countries
- 1
- Sponsor
- National Institute of Allergy and Infectious Diseases
- Modality
- rProtein (Recombinant Protein), Biologic
- Conditions
- hepatitis C (HCV)
01
Overview
Phase 2, randomised, open-label trial of peginterferon alfa-2a in hepatitis C (HCV) (2 arms), sponsored by National Institute of Allergy and Infectious Diseases. Primary endpoint: Sustained Virologic Response at 72 weeks. Started Nov 2000; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
IFN + Ribavirin
Interferon alfa-2a plus Ribavirin
PEG-IFN + Ribavirin
Peginterferon alfa-2a plus Ribavirin
03
Who it enrols
HIV-positive patients with chronic hepatitis C, aged 18-65, with specific CD4 and viral load criteria, excluding those with other severe liver diseases, severe mental illness, or prior interferon/ribavirin treatment.
04
Endpoints
Primary
Sustained Virologic Response
Secondary
Histologic Response
Safety and Tolerability
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