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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)

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ClinicalTrials.gov Identifier: NCT01399619
Recruitment Status : Completed
First Posted : July 22, 2011
Results First Posted : September 4, 2015
Last Update Posted : August 29, 2016
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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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

Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic Drug: PegIFN/RBV Drug: BI201335 Drug: BI201335 24W Drug: Bi 201335 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 310 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of 120mg and 240mg BI 201335 Once Daily in Combination With Pegylated Interferon Alpha and Ribavirin for Treatment of Chronic Hepatitis C (HCV) Genotype 1 Infection in HIV/HCV Co-infected Patients. A Multinational, Randomised, Parallel Group, Open-label Trial.
Study Start Date : September 2011
Actual Primary Completion Date : September 2013
Actual Study Completion Date : June 2014

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Arms and Interventions
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Arm Intervention/treatment
Experimental: BI201335 12W
patient to receive two capsules of BI 201335 once a day for 12 weeks and pegIFN/RBV for 24 or 48 weeks
 Drug: PegIFN/RBV
PegIFN/RBV for 24 or 48w

Drug: BI201335
BI201335 for 12w
Experimental: BI 201335 24W
patient to receive two capsules of BI 201335 once a day for 24 weeks and PegIFN/RBV for 24 or 48 weeks
 Drug: BI201335 24W
BI201335 for 24w

Drug: PegIFN/RBV
PegIFN/RBV for 24 or 48w
Experimental: BI 201335 24 W
patient to receive one capsule of BI 201335 once a day for 24 weeks and pegIFN/RBV for 24 or 48 weeks
 Drug: PegIFN/RBV
PegIFN/RBV for 24 or 48w

Drug: Bi 201335
BI 201335 for 24 w


Outcome Measures
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Primary Outcome Measures :
  1. Sustained Virological Response (SVR12) [ Time Frame: 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 :
  1. Virological Response 24 Weeks Post Treatment (SVR24) [ Time Frame: 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.

  2. Early Treatment Success (ETS) [ Time Frame: 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

  3. The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment (EoT) When SVR12=Yes [ Time Frame: 48 weeks ]
    The number of participants with Alanine Aminotransferase (ALT) normalisation at End of Treatment (EoT) when SVR12=yes. BL stands for baseline.

  4. The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment When SVR12=no [ Time Frame: 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.

  5. The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=Yes [ Time Frame: 60 weeks ]
    The number of participants with ALT in normal range at post treatment (SVR12 Visit) when SVR12=yes. BL = baseline.

  6. The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=no [ Time Frame: 60 weeks ]
    The number of participants with ALT in normal range at post treatment (SVR12 Visit) when SVR12=no. BL = baseline.

  7. The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=Yes [ Time Frame: 48 weeks ]
    The number of participants with Aspartate Aminotransferase (AST) normalisation at End of Treatment when SVR12=yes. BL = baseline.

  8. The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=no [ Time Frame: 48 weeks ]
    The number of participants with Aspartate Aminotransferase (AST) normalisation at End of Treatment when SVR12=no. BL = baseline.

  9. The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=Yes [ Time Frame: 60 weeks ]
    The number of participants with AST in normal range at Post Treatment (SVR12 Visit) when SVR12=yes. BL = baseline.

  10. The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=no [ Time Frame: 60 weeks ]
    The number of participants with AST in normal range at Post Treatment (SVR12 Visit) when SVR12=no. BL = baseline.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Chronic hepatitis C (HCV) genotype 1 infection
  2. Chronic Human Immunodeficiency Virus (HIV) -1 infection
  3. HCV treatment naive or HCV treatment experienced but only relapsers
  4. Age 18 to 70 years
  5. Antiretroviral treatment naive or on stable Highly Active Antiretroviral Therapy (HAART)
  6. Karnofsky score >70
  7. HCV viral load >1.000 IU/mL

Exclusion criteria:

  1. HCV infection of mixed genotype (1/2, 1/3, 1/4)
  2. Evidence of acute or chronic liver due to chronic HCV infection
  3. Hepatitis B virus (HBV) infection with presence of HBs-Ag
  4. Active malignancy or history or malignancy within the last 5 years
  5. Received concomitant systemic antiviral (other than antiretroviral), hematopoietic growth factor or immunomodulatory treatment in 28 days prior enrolment.
  6. Decompensated liver disease,as evidenced by ascites, hepatic encephalopathy, esophageal variceal bleeding, and/or laboratory values that add up to >/= 7 points according tho the Child-Turcotte-Pugh classification
  7. Hemoglobin </=11g/dL for women and </= 12 g/dL for men
  8. Patients with stable cardiac disease and Hemoglobin <12g/dL
  9. Known hypersensitivity to any ingredient of the study drugs
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01399619


Locations
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Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01399619    
Other Study ID Numbers: 1220.19
2010-021734-59 ( EudraCT Number: EudraCT )
First Posted: July 22, 2011    Key Record Dates
Results First Posted: September 4, 2015
Last Update Posted: August 29, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
 Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections
Hepatitis, Chronic