Trial record 4 of 4 for:    STARTVerso

Phase III Trial of BI 201335 (Faldaprevir) in Treatment Naive (TN) and Relapser Hepatitis C Virus (HCV)-Human Inmunodeficiency Virus (HIV) Coinfected Patients (STARTverso 4)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01399619
First received: July 20, 2011
Last updated: June 2, 2014
Last verified: June 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Sustained Virological Response (SVR): 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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: 8 weeks ] [ Designated as safety issue: No ]
  • Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) normalisation: ALT and AST in normal range at end of treatment and post-treatment [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Enrollment: 310
Study Start Date: September 2011
Estimated Study Completion Date: October 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01399619

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

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01399619     History of Changes
Other Study ID Numbers: 1220.19, 2010-021734-59
Study First Received: July 20, 2011
Last Updated: June 2, 2014
Health Authority: Brazil: Ministry of Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Italy: Ethics Committee
Spain: Spanish Agency of Medicines
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic

ClinicalTrials.gov processed this record on August 19, 2014