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)

Phase 3

Completed

Conditions: Hepatitis C, Chronic

Interventions: Drug: BI201335 24W
Drug: BI201335
Drug: PegIFN/RBV
Drug: 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

Inclusion Criteria

Not provided

Exclusion Criteria

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
🇨🇭
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
🇨🇭
Bern, Switzerland
1220.19.4406 Boehringer Ingelheim Investigational Site
🇬🇧
Brighton, United Kingdom
1220.19.4102 Boehringer Ingelheim Investigational Site
🇨🇭
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
🇨🇭
Basel, Switzerland

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Recruitment & Eligibility

Study & Design

Trial Locations

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