the aim of this trial is to evaluate the efficacy and the safety of BI 201335 given for 12 or 24 weeks in combination with PegIFN/RBV given for 24-48 weeks, according to re-randomisation of Early Treatment Success (ETS) patients at 24 weeks to stop PegIFN/RBV or continue PegIFN/RBV until week 48. If no ETS, then PegIFN/RB for 48 weeks, in HCV treatment-naive or relapsers patients coinfected with HIV
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
310
PegIFN/RBV for 24 or 48w
PegIFN/RBV for 24 or 48w
BI201335 for 12w
Sustained Virological Response (SVR12)
Percentage of participants with sustained Virological Response SVR12: Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) level \<25 IU/mL, undetected 12 weeks after the planned end of treatment.
Time frame: 60 weeks
Virological Response 24 Weeks Post Treatment (SVR24)
Percentage of participants with virological response 24 weeks post treatment (SVR24): Plasma HCV RNA level\<25IU/mL (undetected) 24 weeks after the planned end of treatment.
Time frame: 72 weeks
Early Treatment Success (ETS)
Early Treatment Success (ETS): Plasma HCV RNA level\<25 IU/mL (detected or undetected) at Week 4 and HCV RNA\< 25 IU/mL, undetected at Week 8
Time frame: Week 4, week 8 and week 60
The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment (EoT) When SVR12=Yes
The number of participants with Alanine Aminotransferase (ALT) normalisation at End of Treatment (EoT) when SVR12=yes. BL stands for baseline.
Time frame: 48 weeks
The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment When SVR12=no
The number of participants with Alanine Aminotransferase (ALT) normalisation: ALT in normal range at End of Treatment when SVR12=no. BL stands for baseline.
Time frame: 48 weeks
The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=Yes
The number of participants with ALT in normal range at post treatment (SVR12 Visit) when SVR12=yes. BL = baseline.
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BI201335 for 24w
PegIFN/RBV for 24 or 48w
BI 201335 for 24 w
1220.19.0045 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
1220.19.0007 Boehringer Ingelheim Investigational Site
Palm Springs, California, United States
1220.19.0031 Boehringer Ingelheim Investigational Site
San Francisco, California, United States
1220.19.0005 Boehringer Ingelheim Investigational Site
Washington D.C., District of Columbia, United States
1220.19.0086 Boehringer Ingelheim Investigational Site
Fort Lauderdale, Florida, United States
1220.19.0044 Boehringer Ingelheim Investigational Site
Orlando, Florida, United States
1220.19.0004 Boehringer Ingelheim Investigational Site
Vero Beach, Florida, United States
1220.19.0079 Boehringer Ingelheim Investigational Site
Lutherville, Maryland, United States
1220.19.0027 Boehringer Ingelheim Investigational Site
Framingham, Massachusetts, United States
1220.19.0008 Boehringer Ingelheim Investigational Site
Camden, New Jersey, United States
...and 61 more locations
Time frame: 60 weeks
The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=no
The number of participants with ALT in normal range at post treatment (SVR12 Visit) when SVR12=no. BL = baseline.
Time frame: 60 weeks
The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=Yes
The number of participants with Aspartate Aminotransferase (AST) normalisation at End of Treatment when SVR12=yes. BL = baseline.
Time frame: 48 weeks
The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=no
The number of participants with Aspartate Aminotransferase (AST) normalisation at End of Treatment when SVR12=no. BL = baseline.
Time frame: 48 weeks
The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=Yes
The number of participants with AST in normal range at Post Treatment (SVR12 Visit) when SVR12=yes. BL = baseline.
Time frame: 60 weeks
The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=no
The number of participants with AST in normal range at Post Treatment (SVR12 Visit) when SVR12=no. BL = baseline.
Time frame: 60 weeks