Phase III Trial of BI 201335 (Faldaprevir) in Treatment Naive (TN) and Relapser Hepatitis C Virus (HCV)-Human Immunodeficiency Virus (HIV) Coinfected Patients (STARTverso 4)
- Conditions
- Hepatitis C, Chronic
- Interventions
- Registration Number
- NCT01399619
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 310
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BI201335 12W BI201335 patient to receive two capsules of BI 201335 once a day for 12 weeks and pegIFN/RBV for 24 or 48 weeks BI 201335 24W BI201335 24W patient to receive two capsules of BI 201335 once a day for 24 weeks and PegIFN/RBV for 24 or 48 weeks BI 201335 24W PegIFN/RBV patient to receive two capsules of BI 201335 once a day for 24 weeks and PegIFN/RBV for 24 or 48 weeks BI201335 12W PegIFN/RBV patient to receive two capsules of BI 201335 once a day for 12 weeks and pegIFN/RBV for 24 or 48 weeks BI 201335 24 W PegIFN/RBV patient to receive one capsule of BI 201335 once a day for 24 weeks and pegIFN/RBV for 24 or 48 weeks BI 201335 24 W Bi 201335 patient to receive one capsule of BI 201335 once a day for 24 weeks and pegIFN/RBV for 24 or 48 weeks
- Primary Outcome Measures
Name Time Method Sustained Virological Response (SVR12) 60 weeks 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.
- Secondary Outcome Measures
Name Time Method Virological Response 24 Weeks Post Treatment (SVR24) 72 weeks 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.
Early Treatment Success (ETS) Week 4, week 8 and week 60 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
The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment (EoT) When SVR12=Yes 48 weeks The number of participants with Alanine Aminotransferase (ALT) normalisation at End of Treatment (EoT) when SVR12=yes. BL stands for baseline.
The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment When SVR12=no 48 weeks The number of participants with Alanine Aminotransferase (ALT) normalisation: ALT in normal range at End of Treatment when SVR12=no. BL stands for baseline.
The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=Yes 60 weeks The number of participants with ALT in normal range at post treatment (SVR12 Visit) when SVR12=yes. BL = baseline.
The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=no 60 weeks The number of participants with ALT in normal range at post treatment (SVR12 Visit) when SVR12=no. BL = baseline.
The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=Yes 48 weeks The number of participants with Aspartate Aminotransferase (AST) normalisation at End of Treatment when SVR12=yes. BL = baseline.
The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=no 48 weeks The number of participants with Aspartate Aminotransferase (AST) normalisation at End of Treatment when SVR12=no. BL = baseline.
The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=Yes 60 weeks The number of participants with AST in normal range at Post Treatment (SVR12 Visit) when SVR12=yes. BL = baseline.
The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=no 60 weeks The number of participants with AST in normal range at Post Treatment (SVR12 Visit) when SVR12=no. BL = baseline.
Trial Locations
- Locations (71)
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, 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
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