Status:
COMPLETED
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)
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 Trea...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
310 Patients enrolled
Trial Details
Trial ID
NCT01399619
Start Date
September 1 2011
End Date
June 1 2014
Last Update
August 29 2016
Active Locations (71)
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1
1220.19.0045 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
2
1220.19.0007 Boehringer Ingelheim Investigational Site
Palm Springs, California, United States
3
1220.19.0031 Boehringer Ingelheim Investigational Site
San Francisco, California, United States
4
1220.19.0005 Boehringer Ingelheim Investigational Site
Washington D.C., District of Columbia, United States