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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)

Primary Purpose

Hepatitis C, Chronic

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
PegIFN/RBV
PegIFN/RBV
BI201335
BI201335 24W
PegIFN/RBV
Bi 201335
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C, Chronic

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 1220.19.0045 Boehringer Ingelheim Investigational Site
  • 1220.19.0007 Boehringer Ingelheim Investigational Site
  • 1220.19.0031 Boehringer Ingelheim Investigational Site
  • 1220.19.0005 Boehringer Ingelheim Investigational Site
  • 1220.19.0086 Boehringer Ingelheim Investigational Site
  • 1220.19.0044 Boehringer Ingelheim Investigational Site
  • 1220.19.0004 Boehringer Ingelheim Investigational Site
  • 1220.19.0079 Boehringer Ingelheim Investigational Site
  • 1220.19.0027 Boehringer Ingelheim Investigational Site
  • 1220.19.0008 Boehringer Ingelheim Investigational Site
  • 1220.19.0009 Boehringer Ingelheim Investigational Site
  • 1220.19.0011 Boehringer Ingelheim Investigational Site
  • 1220.19.0006 Boehringer Ingelheim Investigational Site
  • 1220.19.0014 Boehringer Ingelheim Investigational Site
  • 1220.19.0084 Boehringer Ingelheim Investigational Site
  • 1220.19.0021 Boehringer Ingelheim Investigational Site
  • 1220.19.0013 Boehringer Ingelheim Investigational Site
  • 1220.19.0029 Boehringer Ingelheim Investigational Site
  • 1220.19.0012 Boehringer Ingelheim Investigational Site
  • 1220.19.0060 Boehringer Ingelheim Investigational Site
  • 1220.19.0016 Boehringer Ingelheim Investigational Site
  • 1220.19.0026 Boehringer Ingelheim Investigational Site
  • 1220.19.5502 Boehringer Ingelheim Investigational Site
  • 1220.19.5508 Boehringer Ingelheim Investigational Site
  • 1220.19.5506 Boehringer Ingelheim Investigational Site
  • 1220.19.5503 Boehringer Ingelheim Investigational Site
  • 1220.19.5501 Boehringer Ingelheim Investigational Site
  • 1220.19.5505 Boehringer Ingelheim Investigational Site
  • 1220.19.3306 Boehringer Ingelheim Investigational Site
  • 1220.19.3303 Boehringer Ingelheim Investigational Site
  • 1220.19.3304 Boehringer Ingelheim Investigational Site
  • 1220.19.3307 Boehringer Ingelheim Investigational Site
  • 1220.19.3301 Boehringer Ingelheim Investigational Site
  • 1220.19.3305 Boehringer Ingelheim Investigational Site
  • 1220.19.4902 Boehringer Ingelheim Investigational Site
  • 1220.19.4921 Boehringer Ingelheim Investigational Site
  • 1220.19.4901 Boehringer Ingelheim Investigational Site
  • 1220.19.4924 Boehringer Ingelheim Investigational Site
  • 1220.19.4919 Boehringer Ingelheim Investigational Site
  • 1220.19.4920 Boehringer Ingelheim Investigational Site
  • 1220.19.4905 Boehringer Ingelheim Investigational Site
  • 1220.19.4922 Boehringer Ingelheim Investigational Site
  • 1220.19.4923 Boehringer Ingelheim Investigational Site
  • 1220.19.3901 Boehringer Ingelheim Investigational Site
  • 1220.19.3902 Boehringer Ingelheim Investigational Site
  • 1220.19.3906 Boehringer Ingelheim Investigational Site
  • 1220.19.3907 Boehringer Ingelheim Investigational Site
  • 1220.19.3905 Boehringer Ingelheim Investigational Site
  • 1220.19.3903 Boehringer Ingelheim Investigational Site
  • 1220.19.3904 Boehringer Ingelheim Investigational Site
  • 1220.19.3404 Boehringer Ingelheim Investigational Site
  • 1220.19.3401 Boehringer Ingelheim Investigational Site
  • 1220.19.3403 Boehringer Ingelheim Investigational Site
  • 1220.19.3409 Boehringer Ingelheim Investigational Site
  • 1220.19.3402 Boehringer Ingelheim Investigational Site
  • 1220.19.3405 Boehringer Ingelheim Investigational Site
  • 1220.19.3406 Boehringer Ingelheim Investigational Site
  • 1220.19.3407 Boehringer Ingelheim Investigational Site
  • 1220.19.3408 Boehringer Ingelheim Investigational Site
  • 1220.19.4101 Boehringer Ingelheim Investigational Site
  • 1220.19.4103 Boehringer Ingelheim Investigational Site
  • 1220.19.4102 Boehringer Ingelheim Investigational Site
  • 1220.19.4104 Boehringer Ingelheim Investigational Site
  • 1220.19.4406 Boehringer Ingelheim Investigational Site
  • 1220.19.4407 Boehringer Ingelheim Investigational Site
  • 1220.19.4401 Boehringer Ingelheim Investigational Site
  • 1220.19.4402 Boehringer Ingelheim Investigational Site
  • 1220.19.4403 Boehringer Ingelheim Investigational Site
  • 1220.19.4404 Boehringer Ingelheim Investigational Site
  • 1220.19.4408 Boehringer Ingelheim Investigational Site
  • 1220.19.4405 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

BI201335 12W

BI 201335 24W

BI 201335 24 W

Arm Description

patient to receive two capsules of BI 201335 once a day for 12 weeks and pegIFN/RBV for 24 or 48 weeks

patient to receive two capsules of BI 201335 once a day for 24 weeks and PegIFN/RBV for 24 or 48 weeks

patient to receive one capsule of BI 201335 once a day for 24 weeks and pegIFN/RBV for 24 or 48 weeks

Outcomes

Primary Outcome Measures

Sustained Virological Response (SVR12)
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

Virological Response 24 Weeks Post Treatment (SVR24)
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)
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
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
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
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
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
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
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
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
The number of participants with AST in normal range at Post Treatment (SVR12 Visit) when SVR12=no. BL = baseline.

Full Information

First Posted
July 20, 2011
Last Updated
July 28, 2016
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT01399619
Brief Title
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)
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 Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
310 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BI201335 12W
Arm Type
Experimental
Arm Description
patient to receive two capsules of BI 201335 once a day for 12 weeks and pegIFN/RBV for 24 or 48 weeks
Arm Title
BI 201335 24W
Arm Type
Experimental
Arm Description
patient to receive two capsules of BI 201335 once a day for 24 weeks and PegIFN/RBV for 24 or 48 weeks
Arm Title
BI 201335 24 W
Arm Type
Experimental
Arm Description
patient to receive one capsule of BI 201335 once a day for 24 weeks and pegIFN/RBV for 24 or 48 weeks
Intervention Type
Drug
Intervention Name(s)
PegIFN/RBV
Intervention Description
PegIFN/RBV for 24 or 48w
Intervention Type
Drug
Intervention Name(s)
PegIFN/RBV
Intervention Description
PegIFN/RBV for 24 or 48w
Intervention Type
Drug
Intervention Name(s)
BI201335
Intervention Description
BI201335 for 12w
Intervention Type
Drug
Intervention Name(s)
BI201335 24W
Intervention Description
BI201335 for 24w
Intervention Type
Drug
Intervention Name(s)
PegIFN/RBV
Intervention Description
PegIFN/RBV for 24 or 48w
Intervention Type
Drug
Intervention Name(s)
Bi 201335
Intervention Description
BI 201335 for 24 w
Primary Outcome Measure Information:
Title
Sustained Virological Response (SVR12)
Description
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.
Time Frame
60 weeks
Secondary Outcome Measure Information:
Title
Virological Response 24 Weeks Post Treatment (SVR24)
Description
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.
Time Frame
72 weeks
Title
Early Treatment Success (ETS)
Description
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
Time Frame
Week 4, week 8 and week 60
Title
The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment (EoT) When SVR12=Yes
Description
The number of participants with Alanine Aminotransferase (ALT) normalisation at End of Treatment (EoT) when SVR12=yes. BL stands for baseline.
Time Frame
48 weeks
Title
The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment When SVR12=no
Description
The number of participants with Alanine Aminotransferase (ALT) normalisation: ALT in normal range at End of Treatment when SVR12=no. BL stands for baseline.
Time Frame
48 weeks
Title
The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=Yes
Description
The number of participants with ALT in normal range at post treatment (SVR12 Visit) when SVR12=yes. BL = baseline.
Time Frame
60 weeks
Title
The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=no
Description
The number of participants with ALT in normal range at post treatment (SVR12 Visit) when SVR12=no. BL = baseline.
Time Frame
60 weeks
Title
The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=Yes
Description
The number of participants with Aspartate Aminotransferase (AST) normalisation at End of Treatment when SVR12=yes. BL = baseline.
Time Frame
48 weeks
Title
The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=no
Description
The number of participants with Aspartate Aminotransferase (AST) normalisation at End of Treatment when SVR12=no. BL = baseline.
Time Frame
48 weeks
Title
The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=Yes
Description
The number of participants with AST in normal range at Post Treatment (SVR12 Visit) when SVR12=yes. BL = baseline.
Time Frame
60 weeks
Title
The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=no
Description
The number of participants with AST in normal range at Post Treatment (SVR12 Visit) when SVR12=no. BL = baseline.
Time Frame
60 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Chronic hepatitis C (HCV) genotype 1 infection Chronic Human Immunodeficiency Virus (HIV) -1 infection HCV treatment naive or HCV treatment experienced but only relapsers Age 18 to 70 years Antiretroviral treatment naive or on stable Highly Active Antiretroviral Therapy (HAART) Karnofsky score >70 HCV viral load >1.000 IU/mL Exclusion criteria: HCV infection of mixed genotype (1/2, 1/3, 1/4) Evidence of acute or chronic liver due to chronic HCV infection Hepatitis B virus (HBV) infection with presence of HBs-Ag Active malignancy or history or malignancy within the last 5 years Received concomitant systemic antiviral (other than antiretroviral), hematopoietic growth factor or immunomodulatory treatment in 28 days prior enrolment. 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 Hemoglobin </=11g/dL for women and </= 12 g/dL for men Patients with stable cardiac disease and Hemoglobin <12g/dL Known hypersensitivity to any ingredient of the study drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1220.19.0045 Boehringer Ingelheim Investigational Site
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
1220.19.0007 Boehringer Ingelheim Investigational Site
City
Palm Springs
State/Province
California
Country
United States
Facility Name
1220.19.0031 Boehringer Ingelheim Investigational Site
City
San Francisco
State/Province
California
Country
United States
Facility Name
1220.19.0005 Boehringer Ingelheim Investigational Site
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
1220.19.0086 Boehringer Ingelheim Investigational Site
City
Fort Lauderdale
State/Province
Florida
Country
United States
Facility Name
1220.19.0044 Boehringer Ingelheim Investigational Site
City
Orlando
State/Province
Florida
Country
United States
Facility Name
1220.19.0004 Boehringer Ingelheim Investigational Site
City
Vero Beach
State/Province
Florida
Country
United States
Facility Name
1220.19.0079 Boehringer Ingelheim Investigational Site
City
Lutherville
State/Province
Maryland
Country
United States
Facility Name
1220.19.0027 Boehringer Ingelheim Investigational Site
City
Framingham
State/Province
Massachusetts
Country
United States
Facility Name
1220.19.0008 Boehringer Ingelheim Investigational Site
City
Camden
State/Province
New Jersey
Country
United States
Facility Name
1220.19.0009 Boehringer Ingelheim Investigational Site
City
Hillsborough
State/Province
New Jersey
Country
United States
Facility Name
1220.19.0011 Boehringer Ingelheim Investigational Site
City
Albany
State/Province
New York
Country
United States
Facility Name
1220.19.0006 Boehringer Ingelheim Investigational Site
City
New York
State/Province
New York
Country
United States
Facility Name
1220.19.0014 Boehringer Ingelheim Investigational Site
City
New York
State/Province
New York
Country
United States
Facility Name
1220.19.0084 Boehringer Ingelheim Investigational Site
City
New York
State/Province
New York
Country
United States
Facility Name
1220.19.0021 Boehringer Ingelheim Investigational Site
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
1220.19.0013 Boehringer Ingelheim Investigational Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
1220.19.0029 Boehringer Ingelheim Investigational Site
City
Austin
State/Province
Texas
Country
United States
Facility Name
1220.19.0012 Boehringer Ingelheim Investigational Site
City
Dallas
State/Province
Texas
Country
United States
Facility Name
1220.19.0060 Boehringer Ingelheim Investigational Site
City
Fort Worth
State/Province
Texas
Country
United States
Facility Name
1220.19.0016 Boehringer Ingelheim Investigational Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
1220.19.0026 Boehringer Ingelheim Investigational Site
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
1220.19.5502 Boehringer Ingelheim Investigational Site
City
Rio de Janeiro - RJ
Country
Brazil
Facility Name
1220.19.5508 Boehringer Ingelheim Investigational Site
City
Rio de Janeiro
Country
Brazil
Facility Name
1220.19.5506 Boehringer Ingelheim Investigational Site
City
Salvador
Country
Brazil
Facility Name
1220.19.5503 Boehringer Ingelheim Investigational Site
City
Sao Paulo
Country
Brazil
Facility Name
1220.19.5501 Boehringer Ingelheim Investigational Site
City
São Paulo - SP
Country
Brazil
Facility Name
1220.19.5505 Boehringer Ingelheim Investigational Site
City
São Paulo
Country
Brazil
Facility Name
1220.19.3306 Boehringer Ingelheim Investigational Site
City
Lyon
Country
France
Facility Name
1220.19.3303 Boehringer Ingelheim Investigational Site
City
Marseille Cedex 08
Country
France
Facility Name
1220.19.3304 Boehringer Ingelheim Investigational Site
City
Marseille cedex 9
Country
France
Facility Name
1220.19.3307 Boehringer Ingelheim Investigational Site
City
Paris Cedex 12
Country
France
Facility Name
1220.19.3301 Boehringer Ingelheim Investigational Site
City
Paris
Country
France
Facility Name
1220.19.3305 Boehringer Ingelheim Investigational Site
City
Paris
Country
France
Facility Name
1220.19.4902 Boehringer Ingelheim Investigational Site
City
Berlin
Country
Germany
Facility Name
1220.19.4921 Boehringer Ingelheim Investigational Site
City
Berlin
Country
Germany
Facility Name
1220.19.4901 Boehringer Ingelheim Investigational Site
City
Bonn
Country
Germany
Facility Name
1220.19.4924 Boehringer Ingelheim Investigational Site
City
Frankfurt am Main
Country
Germany
Facility Name
1220.19.4919 Boehringer Ingelheim Investigational Site
City
Hamburg
Country
Germany
Facility Name
1220.19.4920 Boehringer Ingelheim Investigational Site
City
Hamburg
Country
Germany
Facility Name
1220.19.4905 Boehringer Ingelheim Investigational Site
City
München
Country
Germany
Facility Name
1220.19.4922 Boehringer Ingelheim Investigational Site
City
München
Country
Germany
Facility Name
1220.19.4923 Boehringer Ingelheim Investigational Site
City
Würzburg
Country
Germany
Facility Name
1220.19.3901 Boehringer Ingelheim Investigational Site
City
Antella (fi)
Country
Italy
Facility Name
1220.19.3902 Boehringer Ingelheim Investigational Site
City
Bari
Country
Italy
Facility Name
1220.19.3906 Boehringer Ingelheim Investigational Site
City
Brescia
Country
Italy
Facility Name
1220.19.3907 Boehringer Ingelheim Investigational Site
City
Milano
Country
Italy
Facility Name
1220.19.3905 Boehringer Ingelheim Investigational Site
City
Pavia
Country
Italy
Facility Name
1220.19.3903 Boehringer Ingelheim Investigational Site
City
Roma
Country
Italy
Facility Name
1220.19.3904 Boehringer Ingelheim Investigational Site
City
Torino
Country
Italy
Facility Name
1220.19.3404 Boehringer Ingelheim Investigational Site
City
Badalona
Country
Spain
Facility Name
1220.19.3401 Boehringer Ingelheim Investigational Site
City
Barcelona
Country
Spain
Facility Name
1220.19.3403 Boehringer Ingelheim Investigational Site
City
Barcelona
Country
Spain
Facility Name
1220.19.3409 Boehringer Ingelheim Investigational Site
City
Barcelona
Country
Spain
Facility Name
1220.19.3402 Boehringer Ingelheim Investigational Site
City
L'Hospitalet de Llobregat
Country
Spain
Facility Name
1220.19.3405 Boehringer Ingelheim Investigational Site
City
Madrid
Country
Spain
Facility Name
1220.19.3406 Boehringer Ingelheim Investigational Site
City
Madrid
Country
Spain
Facility Name
1220.19.3407 Boehringer Ingelheim Investigational Site
City
Madrid
Country
Spain
Facility Name
1220.19.3408 Boehringer Ingelheim Investigational Site
City
Sevilla
Country
Spain
Facility Name
1220.19.4101 Boehringer Ingelheim Investigational Site
City
Basel
Country
Switzerland
Facility Name
1220.19.4103 Boehringer Ingelheim Investigational Site
City
Bern
Country
Switzerland
Facility Name
1220.19.4102 Boehringer Ingelheim Investigational Site
City
Lugano
Country
Switzerland
Facility Name
1220.19.4104 Boehringer Ingelheim Investigational Site
City
Zürich
Country
Switzerland
Facility Name
1220.19.4406 Boehringer Ingelheim Investigational Site
City
Brighton
Country
United Kingdom
Facility Name
1220.19.4407 Boehringer Ingelheim Investigational Site
City
Edinburgh
Country
United Kingdom
Facility Name
1220.19.4401 Boehringer Ingelheim Investigational Site
City
London
Country
United Kingdom
Facility Name
1220.19.4402 Boehringer Ingelheim Investigational Site
City
London
Country
United Kingdom
Facility Name
1220.19.4403 Boehringer Ingelheim Investigational Site
City
London
Country
United Kingdom
Facility Name
1220.19.4404 Boehringer Ingelheim Investigational Site
City
London
Country
United Kingdom
Facility Name
1220.19.4408 Boehringer Ingelheim Investigational Site
City
London
Country
United Kingdom
Facility Name
1220.19.4405 Boehringer Ingelheim Investigational Site
City
Manchester
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
25710287
Citation
Dieterich D, Nelson M, Soriano V, Arasteh K, Guardiola JM, Rockstroh JK, Bhagani S, Laguno M, Tural C, Ingiliz P, Jain MK, Stern JO, Manero M, Vinisko R, Kort J; STARTVerso4 study group. Faldaprevir and pegylated interferon alpha-2a/ribavirin in individuals co-infected with hepatitis C virus genotype-1 and HIV. AIDS. 2015 Mar 13;29(5):571-81. doi: 10.1097/QAD.0000000000000579.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com/
Description
Related Info

Learn more about this trial

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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