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)

Completed · Phase 3

Conditions studied: Hepatitis C, Chronic

In brief

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

Key facts

Study ID

NCT01399619

Run by

Boehringer Ingelheim

People needed

310

Starts

2011-09-01

Expected to finish

2014-06-01

Last updated by the study team

2016-08-29

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 1220.19.0007 Boehringer Ingelheim Investigational Site — Palm Springs, California, United States
• 1220.19.0031 Boehringer Ingelheim Investigational Site — San Francisco, California, United States
• 1220.19.0005 Boehringer Ingelheim Investigational Site — Washington D.C., District of Columbia, United States
• 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
• 1220.19.0079 Boehringer Ingelheim Investigational Site — Lutherville, Maryland, United States
• 1220.19.0027 Boehringer Ingelheim Investigational Site — Framingham, Massachusetts, United States
• 1220.19.0008 Boehringer Ingelheim Investigational Site — Camden, New Jersey, United States
• 1220.19.0009 Boehringer Ingelheim Investigational Site — Hillsborough, New Jersey, United States
• 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
• 1220.19.0021 Boehringer Ingelheim Investigational Site — Winston-Salem, North Carolina, United States
• 1220.19.0013 Boehringer Ingelheim Investigational Site — Philadelphia, Pennsylvania, United States
• 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
• 1220.19.0026 Boehringer Ingelheim Investigational Site — Richmond, Virginia, United States
• 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
• 1220.19.0045 Boehringer Ingelheim Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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