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)

July 28, 2016 updated by: Boehringer Ingelheim

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

310

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil
        • 1220.19.5508 Boehringer Ingelheim Investigational Site
      • Rio de Janeiro - RJ, Brazil
        • 1220.19.5502 Boehringer Ingelheim Investigational Site
      • Salvador, Brazil
        • 1220.19.5506 Boehringer Ingelheim Investigational Site
      • Sao Paulo, Brazil
        • 1220.19.5503 Boehringer Ingelheim Investigational Site
      • São Paulo, Brazil
        • 1220.19.5505 Boehringer Ingelheim Investigational Site
      • São Paulo - SP, Brazil
        • 1220.19.5501 Boehringer Ingelheim Investigational Site
  • France
      • Lyon, France
        • 1220.19.3306 Boehringer Ingelheim Investigational Site
      • Marseille Cedex 08, France
        • 1220.19.3303 Boehringer Ingelheim Investigational Site
      • Marseille cedex 9, France
        • 1220.19.3304 Boehringer Ingelheim Investigational Site
      • Paris, France
        • 1220.19.3301 Boehringer Ingelheim Investigational Site
      • Paris, France
        • 1220.19.3305 Boehringer Ingelheim Investigational Site
      • Paris Cedex 12, France
        • 1220.19.3307 Boehringer Ingelheim Investigational Site
  • Germany
      • Berlin, Germany
        • 1220.19.4902 Boehringer Ingelheim Investigational Site
      • Berlin, Germany
        • 1220.19.4921 Boehringer Ingelheim Investigational Site
      • Bonn, Germany
        • 1220.19.4901 Boehringer Ingelheim Investigational Site
      • Frankfurt am Main, Germany
        • 1220.19.4924 Boehringer Ingelheim Investigational Site
      • Hamburg, Germany
        • 1220.19.4919 Boehringer Ingelheim Investigational Site
      • Hamburg, Germany
        • 1220.19.4920 Boehringer Ingelheim Investigational Site
      • München, Germany
        • 1220.19.4905 Boehringer Ingelheim Investigational Site
      • München, Germany
        • 1220.19.4922 Boehringer Ingelheim Investigational Site
      • Würzburg, Germany
        • 1220.19.4923 Boehringer Ingelheim Investigational Site
  • Italy
      • Antella (fi), Italy
        • 1220.19.3901 Boehringer Ingelheim Investigational Site
      • Bari, Italy
        • 1220.19.3902 Boehringer Ingelheim Investigational Site
      • Brescia, Italy
        • 1220.19.3906 Boehringer Ingelheim Investigational Site
      • Milano, Italy
        • 1220.19.3907 Boehringer Ingelheim Investigational Site
      • Pavia, Italy
        • 1220.19.3905 Boehringer Ingelheim Investigational Site
      • Roma, Italy
        • 1220.19.3903 Boehringer Ingelheim Investigational Site
      • Torino, Italy
        • 1220.19.3904 Boehringer Ingelheim Investigational Site
  • Spain
      • Badalona, Spain
        • 1220.19.3404 Boehringer Ingelheim Investigational Site
      • Barcelona, Spain
        • 1220.19.3401 Boehringer Ingelheim Investigational Site
      • Barcelona, Spain
        • 1220.19.3403 Boehringer Ingelheim Investigational Site
      • Barcelona, Spain
        • 1220.19.3409 Boehringer Ingelheim Investigational Site
      • L'Hospitalet de Llobregat, Spain
        • 1220.19.3402 Boehringer Ingelheim Investigational Site
      • Madrid, Spain
        • 1220.19.3405 Boehringer Ingelheim Investigational Site
      • Madrid, Spain
        • 1220.19.3406 Boehringer Ingelheim Investigational Site
      • Madrid, Spain
        • 1220.19.3407 Boehringer Ingelheim Investigational Site
      • Sevilla, Spain
        • 1220.19.3408 Boehringer Ingelheim Investigational Site
  • Switzerland
      • Basel, Switzerland
        • 1220.19.4101 Boehringer Ingelheim Investigational Site
      • Bern, Switzerland
        • 1220.19.4103 Boehringer Ingelheim Investigational Site
      • Lugano, Switzerland
        • 1220.19.4102 Boehringer Ingelheim Investigational Site
      • Zürich, Switzerland
        • 1220.19.4104 Boehringer Ingelheim Investigational Site
  • United Kingdom
      • Brighton, United Kingdom
        • 1220.19.4406 Boehringer Ingelheim Investigational Site
      • Edinburgh, United Kingdom
        • 1220.19.4407 Boehringer Ingelheim Investigational Site
      • London, United Kingdom
        • 1220.19.4401 Boehringer Ingelheim Investigational Site
      • London, United Kingdom
        • 1220.19.4402 Boehringer Ingelheim Investigational Site
      • London, United Kingdom
        • 1220.19.4403 Boehringer Ingelheim Investigational Site
      • London, United Kingdom
        • 1220.19.4404 Boehringer Ingelheim Investigational Site
      • London, United Kingdom
        • 1220.19.4408 Boehringer Ingelheim Investigational Site
      • Manchester, United Kingdom
        • 1220.19.4405 Boehringer Ingelheim Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • 1220.19.0045 Boehringer Ingelheim Investigational Site
    • California
      • Palm Springs, California, United States
        • 1220.19.0007 Boehringer Ingelheim Investigational Site
      • San Francisco, California, United States
        • 1220.19.0031 Boehringer Ingelheim Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States
        • 1220.19.0005 Boehringer Ingelheim Investigational Site
    • Florida
      • Fort Lauderdale, Florida, United States
        • 1220.19.0086 Boehringer Ingelheim Investigational Site
      • Orlando, Florida, United States
        • 1220.19.0044 Boehringer Ingelheim Investigational Site
      • Vero Beach, Florida, United States
        • 1220.19.0004 Boehringer Ingelheim Investigational Site
    • Maryland
      • Lutherville, Maryland, United States
        • 1220.19.0079 Boehringer Ingelheim Investigational Site
    • Massachusetts
      • Framingham, Massachusetts, United States
        • 1220.19.0027 Boehringer Ingelheim Investigational Site
    • New Jersey
      • Camden, New Jersey, United States
        • 1220.19.0008 Boehringer Ingelheim Investigational Site
      • Hillsborough, New Jersey, United States
        • 1220.19.0009 Boehringer Ingelheim Investigational Site
    • New York
      • Albany, New York, United States
        • 1220.19.0011 Boehringer Ingelheim Investigational Site
      • New York, New York, 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
    • North Carolina
      • Winston-Salem, North Carolina, United States
        • 1220.19.0021 Boehringer Ingelheim Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • 1220.19.0013 Boehringer Ingelheim Investigational Site
    • Texas
      • Austin, Texas, United States
        • 1220.19.0029 Boehringer Ingelheim Investigational Site
      • Dallas, Texas, United States
        • 1220.19.0012 Boehringer Ingelheim Investigational Site
      • Fort Worth, Texas, United States
        • 1220.19.0060 Boehringer Ingelheim Investigational Site
      • San Antonio, Texas, United States
        • 1220.19.0016 Boehringer Ingelheim Investigational Site
    • Virginia
      • Richmond, Virginia, United States
        • 1220.19.0026 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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: PegIFN/RBV
PegIFN/RBV for 24 or 48w
Drug: BI201335 24W
BI201335 for 24w
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
60 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
72 weeks
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
Week 4, week 8 and week 60
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.
48 weeks
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.
48 weeks
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.
60 weeks
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.
60 weeks
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.
48 weeks
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.
48 weeks
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.
60 weeks
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.
60 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

July 20, 2011

First Submitted That Met QC Criteria

July 21, 2011

First Posted (Estimate)

July 22, 2011

Study Record Updates

Last Update Posted (Estimate)

August 29, 2016

Last Update Submitted That Met QC Criteria

July 28, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1220.19
  • 2010-021734-59 (EudraCT Number: EudraCT)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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