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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 Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01399619
First received: July 20, 2011
Last updated: May 15, 2013
Last verified: May 2013
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

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 ]

Estimated Enrollment: 310
Study Start Date: September 2011
Estimated Study Completion Date: November 2014
Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01399619

  Show 71 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01399619     History of Changes
Other Study ID Numbers: 1220.19, 2010-021734-59
Study First Received: July 20, 2011
Last Updated: May 15, 2013
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 May 19, 2013