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
- Drug: BI201335 24WDrug: BI201335Drug: PegIFN/RBVDrug: Bi 201335
- 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)
1220.19.0013 Boehringer Ingelheim Investigational Site
🇺🇸Philadelphia, Pennsylvania, United States
1220.19.5505 Boehringer Ingelheim Investigational Site
🇧🇷São Paulo, Brazil
1220.19.3901 Boehringer Ingelheim Investigational Site
🇮🇹Antella (fi), Italy
1220.19.3906 Boehringer Ingelheim Investigational Site
🇮🇹Brescia, Italy
1220.19.3301 Boehringer Ingelheim Investigational Site
🇫🇷Paris, France
1220.19.3303 Boehringer Ingelheim Investigational Site
🇫🇷Marseille Cedex 08, France
1220.19.3402 Boehringer Ingelheim Investigational Site
🇪🇸L'Hospitalet de Llobregat, Spain
1220.19.3306 Boehringer Ingelheim Investigational Site
🇫🇷Lyon, France
1220.19.4901 Boehringer Ingelheim Investigational Site
🇩🇪Bonn, Germany
1220.19.4923 Boehringer Ingelheim Investigational Site
🇩🇪Würzburg, Germany
1220.19.4104 Boehringer Ingelheim Investigational Site
🇨ðŸ‡Zürich, Switzerland
1220.19.3307 Boehringer Ingelheim Investigational Site
🇫🇷Paris Cedex 12, France
1220.19.4921 Boehringer Ingelheim Investigational Site
🇩🇪Berlin, Germany
1220.19.4919 Boehringer Ingelheim Investigational Site
🇩🇪Hamburg, Germany
1220.19.3305 Boehringer Ingelheim Investigational Site
🇫🇷Paris, France
1220.19.4404 Boehringer Ingelheim Investigational Site
🇬🇧London, United Kingdom
1220.19.4405 Boehringer Ingelheim Investigational Site
🇬🇧Manchester, United Kingdom
1220.19.3304 Boehringer Ingelheim Investigational Site
🇫🇷Marseille cedex 9, France
1220.19.3406 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1220.19.4924 Boehringer Ingelheim Investigational Site
🇩🇪Frankfurt am Main, Germany
1220.19.4905 Boehringer Ingelheim Investigational Site
🇩🇪München, Germany
1220.19.3403 Boehringer Ingelheim Investigational Site
🇪🇸Barcelona, Spain
1220.19.4402 Boehringer Ingelheim Investigational Site
🇬🇧London, United Kingdom
1220.19.3905 Boehringer Ingelheim Investigational Site
🇮🇹Pavia, Italy
1220.19.4920 Boehringer Ingelheim Investigational Site
🇩🇪Hamburg, Germany
1220.19.3404 Boehringer Ingelheim Investigational Site
🇪🇸Badalona, Spain
1220.19.3902 Boehringer Ingelheim Investigational Site
🇮🇹Bari, Italy
1220.19.3907 Boehringer Ingelheim Investigational Site
🇮🇹Milano, Italy
1220.19.3904 Boehringer Ingelheim Investigational Site
🇮🇹Torino, Italy
1220.19.0045 Boehringer Ingelheim Investigational Site
🇺🇸Birmingham, Alabama, United States
1220.19.0031 Boehringer Ingelheim Investigational Site
🇺🇸San Francisco, California, United States
1220.19.4408 Boehringer Ingelheim Investigational Site
🇬🇧London, United Kingdom
1220.19.3408 Boehringer Ingelheim Investigational Site
🇪🇸Sevilla, Spain
1220.19.3903 Boehringer Ingelheim Investigational Site
🇮🇹Roma, Italy
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
1220.19.0006 Boehringer Ingelheim Investigational Site
🇺🇸New York, New York, United States
1220.19.0014 Boehringer Ingelheim Investigational Site
🇺🇸New York, New York, United States
1220.19.0084 Boehringer Ingelheim Investigational Site
🇺🇸New York, New York, United States
1220.19.0021 Boehringer Ingelheim Investigational Site
🇺🇸Winston-Salem, North Carolina, United States
1220.19.0029 Boehringer Ingelheim Investigational Site
🇺🇸Austin, Texas, United States
1220.19.0012 Boehringer Ingelheim Investigational Site
🇺🇸Dallas, Texas, United States
1220.19.5508 Boehringer Ingelheim Investigational Site
🇧🇷Rio de Janeiro, Brazil
1220.19.5506 Boehringer Ingelheim Investigational Site
🇧🇷Salvador, Brazil
1220.19.5503 Boehringer Ingelheim Investigational Site
🇧🇷Sao Paulo, Brazil
1220.19.5501 Boehringer Ingelheim Investigational Site
🇧🇷São Paulo - SP, Brazil
1220.19.4902 Boehringer Ingelheim Investigational Site
🇩🇪Berlin, Germany
1220.19.4922 Boehringer Ingelheim Investigational Site
🇩🇪München, Germany
1220.19.3405 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1220.19.4103 Boehringer Ingelheim Investigational Site
🇨ðŸ‡Bern, Switzerland
1220.19.4406 Boehringer Ingelheim Investigational Site
🇬🇧Brighton, United Kingdom
1220.19.4102 Boehringer Ingelheim Investigational Site
🇨ðŸ‡Lugano, Switzerland
1220.19.4407 Boehringer Ingelheim Investigational Site
🇬🇧Edinburgh, United Kingdom
1220.19.4401 Boehringer Ingelheim Investigational Site
🇬🇧London, United Kingdom
1220.19.4403 Boehringer Ingelheim Investigational Site
🇬🇧London, United Kingdom
1220.19.3409 Boehringer Ingelheim Investigational Site
🇪🇸Barcelona, Spain
1220.19.0026 Boehringer Ingelheim Investigational Site
🇺🇸Richmond, Virginia, United States
1220.19.0060 Boehringer Ingelheim Investigational Site
🇺🇸Fort Worth, Texas, United States
1220.19.3401 Boehringer Ingelheim Investigational Site
🇪🇸Barcelona, Spain
1220.19.0009 Boehringer Ingelheim Investigational Site
🇺🇸Hillsborough, New Jersey, United States
1220.19.0007 Boehringer Ingelheim Investigational Site
🇺🇸Palm Springs, California, United States
1220.19.0011 Boehringer Ingelheim Investigational Site
🇺🇸Albany, New York, United States
1220.19.0008 Boehringer Ingelheim Investigational Site
🇺🇸Camden, New Jersey, United States
1220.19.0016 Boehringer Ingelheim Investigational Site
🇺🇸San Antonio, Texas, United States
1220.19.5502 Boehringer Ingelheim Investigational Site
🇧🇷Rio de Janeiro - RJ, Brazil
1220.19.3407 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1220.19.4101 Boehringer Ingelheim Investigational Site
🇨ðŸ‡Basel, Switzerland