Clinical trial NCT01399619: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C, Chronic
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2011-07-22
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Sustained Virological Response (SVR12)
timeFrame: 60 weeks
Secondary outcomes:
measure: Virological Response 24 Weeks Post Treatment (SVR24)
timeFrame: 72 weeks
measure: Early Treatment Success (ETS)
timeFrame: Week 4, week 8 and week 60
measure: The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment (EoT) When SVR12=Yes
timeFrame: 48 weeks
measure: The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment When SVR12=no
timeFrame: 48 weeks
measure: The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=Yes
timeFrame: 60 weeks
measure: The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=no
timeFrame: 60 weeks
measure: The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=Yes
timeFrame: 48 weeks
measure: The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=no
timeFrame: 48 weeks
measure: The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=Yes
timeFrame: 60 weeks
measure: The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=no
timeFrame: 60 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: 1220.19.0045 Boehringer Ingelheim Investigational Site
state: Alabama
city: Palm Springs
country: United States
facility: 1220.19.0007 Boehringer Ingelheim Investigational Site
state: California
city: San Francisco
country: United States
facility: 1220.19.0031 Boehringer Ingelheim Investigational Site
state: California
city: Washington
country: United States
facility: 1220.19.0005 Boehringer Ingelheim Investigational Site
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: 1220.19.0086 Boehringer Ingelheim Investigational Site
state: Florida
city: Orlando
country: United States
facility: 1220.19.0044 Boehringer Ingelheim Investigational Site
state: Florida
city: Vero Beach
country: United States
facility: 1220.19.0004 Boehringer Ingelheim Investigational Site
state: Florida
city: Lutherville
country: United States
facility: 1220.19.0079 Boehringer Ingelheim Investigational Site
state: Maryland
city: Framingham
country: United States
facility: 1220.19.0027 Boehringer Ingelheim Investigational Site
state: Massachusetts
city: Camden
country: United States
facility: 1220.19.0008 Boehringer Ingelheim Investigational Site
state: New Jersey
city: Hillsborough
country: United States
facility: 1220.19.0009 Boehringer Ingelheim Investigational Site
state: New Jersey
city: Albany
country: United States
facility: 1220.19.0011 Boehringer Ingelheim Investigational Site
state: New York
city: New York
country: United States
facility: 1220.19.0006 Boehringer Ingelheim Investigational Site
state: New York
city: New York
country: United States
facility: 1220.19.0014 Boehringer Ingelheim Investigational Site
state: New York
city: New York
country: United States
facility: 1220.19.0084 Boehringer Ingelheim Investigational Site
state: New York
city: Winston-Salem
country: United States
facility: 1220.19.0021 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Philadelphia
country: United States
facility: 1220.19.0013 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Austin
country: United States
facility: 1220.19.0029 Boehringer Ingelheim Investigational Site
state: Texas
city: Dallas
country: United States
facility: 1220.19.0012 Boehringer Ingelheim Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: 1220.19.0060 Boehringer Ingelheim Investigational Site
state: Texas
city: San Antonio
country: United States
facility: 1220.19.0016 Boehringer Ingelheim Investigational Site
state: Texas
city: Richmond
country: United States
facility: 1220.19.0026 Boehringer Ingelheim Investigational Site
state: Virginia
city: Rio de Janeiro - RJ
country: Brazil
facility: 1220.19.5502 Boehringer Ingelheim Investigational Site
city: Rio de Janeiro
country: Brazil
facility: 1220.19.5508 Boehringer Ingelheim Investigational Site
city: Salvador
country: Brazil
facility: 1220.19.5506 Boehringer Ingelheim Investigational Site
city: Sao Paulo
country: Brazil
facility: 1220.19.5503 Boehringer Ingelheim Investigational Site
city: São Paulo - SP
country: Brazil
facility: 1220.19.5501 Boehringer Ingelheim Investigational Site
city: São Paulo
country: Brazil
facility: 1220.19.5505 Boehringer Ingelheim Investigational Site
city: Lyon
country: France
facility: 1220.19.3306 Boehringer Ingelheim Investigational Site
city: Marseille Cedex 08
country: France
facility: 1220.19.3303 Boehringer Ingelheim Investigational Site
city: Marseille cedex 9
country: France
facility: 1220.19.3304 Boehringer Ingelheim Investigational Site
city: Paris Cedex 12
country: France
facility: 1220.19.3307 Boehringer Ingelheim Investigational Site
city: Paris
country: France
facility: 1220.19.3301 Boehringer Ingelheim Investigational Site
city: Paris
country: France
facility: 1220.19.3305 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1220.19.4902 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1220.19.4921 Boehringer Ingelheim Investigational Site
city: Bonn
country: Germany
facility: 1220.19.4901 Boehringer Ingelheim Investigational Site
city: Frankfurt am Main
country: Germany
facility: 1220.19.4924 Boehringer Ingelheim Investigational Site
city: Hamburg
country: Germany
facility: 1220.19.4919 Boehringer Ingelheim Investigational Site
city: Hamburg
country: Germany
facility: 1220.19.4920 Boehringer Ingelheim Investigational Site
city: München
country: Germany
facility: 1220.19.4905 Boehringer Ingelheim Investigational Site
city: München
country: Germany
facility: 1220.19.4922 Boehringer Ingelheim Investigational Site
city: Würzburg
country: Germany
facility: 1220.19.4923 Boehringer Ingelheim Investigational Site
city: Antella (fi)
country: Italy
facility: 1220.19.3901 Boehringer Ingelheim Investigational Site
city: Bari
country: Italy
facility: 1220.19.3902 Boehringer Ingelheim Investigational Site
city: Brescia
country: Italy
facility: 1220.19.3906 Boehringer Ingelheim Investigational Site
city: Milano
country: Italy
facility: 1220.19.3907 Boehringer Ingelheim Investigational Site
city: Pavia
country: Italy
facility: 1220.19.3905 Boehringer Ingelheim Investigational Site
city: Roma
country: Italy
facility: 1220.19.3903 Boehringer Ingelheim Investigational Site
city: Torino
country: Italy
facility: 1220.19.3904 Boehringer Ingelheim Investigational Site
city: Badalona
country: Spain
facility: 1220.19.3404 Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: 1220.19.3401 Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: 1220.19.3403 Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: 1220.19.3409 Boehringer Ingelheim Investigational Site
city: L'Hospitalet de Llobregat
country: Spain
facility: 1220.19.3402 Boehringer Ingelheim Investigational Site
city: Madrid
country: Spain
facility: 1220.19.3405 Boehringer Ingelheim Investigational Site
city: Madrid
country: Spain
facility: 1220.19.3406 Boehringer Ingelheim Investigational Site
city: Madrid
country: Spain
facility: 1220.19.3407 Boehringer Ingelheim Investigational Site
city: Sevilla
country: Spain
facility: 1220.19.3408 Boehringer Ingelheim Investigational Site
city: Basel
country: Switzerland
facility: 1220.19.4101 Boehringer Ingelheim Investigational Site
city: Bern
country: Switzerland
facility: 1220.19.4103 Boehringer Ingelheim Investigational Site
city: Lugano
country: Switzerland
facility: 1220.19.4102 Boehringer Ingelheim Investigational Site
city: Zürich
country: Switzerland
facility: 1220.19.4104 Boehringer Ingelheim Investigational Site
city: Brighton
country: United Kingdom
facility: 1220.19.4406 Boehringer Ingelheim Investigational Site
city: Edinburgh
country: United Kingdom
facility: 1220.19.4407 Boehringer Ingelheim Investigational Site
city: London
country: United Kingdom
facility: 1220.19.4401 Boehringer Ingelheim Investigational Site
city: London
country: United Kingdom
facility: 1220.19.4402 Boehringer Ingelheim Investigational Site
city: London
country: United Kingdom
facility: 1220.19.4403 Boehringer Ingelheim Investigational Site
city: London
country: United Kingdom
facility: 1220.19.4404 Boehringer Ingelheim Investigational Site
city: London
country: United Kingdom
facility: 1220.19.4408 Boehringer Ingelheim Investigational Site
city: Manchester
country: United Kingdom
facility: 1220.19.4405 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
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.