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)

NCT01399619 | Completed Phase 3 Results

• 2 other identifiers: 1220.192010-021734-59
• Study Type: interventional
• Target: 310
• Locations: 8 countries
• Sites: 71

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

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (1)

• Sustained Virological Response (SVR12)

  Percentage of participants with sustained Virological Response SVR12: Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) level \<25 IU/mL, undetected 12 weeks after the planned end of treatment.

  60 weeks

Secondary Outcomes (10)

• Virological Response 24 Weeks Post Treatment (SVR24)

  72 weeks

• Early Treatment Success (ETS)

  Week 4, week 8 and week 60

• The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment (EoT) When SVR12=Yes

  48 weeks

• The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment When SVR12=no

  48 weeks

• The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=Yes

  60 weeks

Study Arms (3)

BI201335 12W

EXPERIMENTAL

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; Drug: BI201335

BI 201335 24W

EXPERIMENTAL

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; Drug: PegIFN/RBV

BI 201335 24 W

EXPERIMENTAL

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; Drug: Bi 201335

Interventions

PegIFN/RBV DRUG

PegIFN/RBV for 24 or 48w

BI 201335 24 W

BI201335 DRUG

BI201335 for 12w

BI201335 12W

BI201335 24W DRUG

BI201335 for 24w

BI 201335 24W

Bi 201335 DRUG

BI 201335 for 24 w

BI 201335 24 W

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (71)

1220.19.0045 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Location

1220.19.0007 Boehringer Ingelheim Investigational Site

Palm Springs, California, United States

Location

1220.19.0031 Boehringer Ingelheim Investigational Site

San Francisco, California, United States

Location

1220.19.0005 Boehringer Ingelheim Investigational Site

Washington D.C., District of Columbia, United States

Location

1220.19.0086 Boehringer Ingelheim Investigational Site

Fort Lauderdale, Florida, United States

Location

1220.19.0044 Boehringer Ingelheim Investigational Site

Orlando, Florida, United States

Location

1220.19.0004 Boehringer Ingelheim Investigational Site

Vero Beach, Florida, United States

Location

1220.19.0079 Boehringer Ingelheim Investigational Site

Lutherville, Maryland, United States

Location

1220.19.0027 Boehringer Ingelheim Investigational Site

Framingham, Massachusetts, United States

Location

1220.19.0008 Boehringer Ingelheim Investigational Site

Camden, New Jersey, United States

Location

1220.19.0009 Boehringer Ingelheim Investigational Site

Hillsborough, New Jersey, United States

Location

1220.19.0011 Boehringer Ingelheim Investigational Site

Albany, New York, United States

Location

1220.19.0006 Boehringer Ingelheim Investigational Site

New York, New York, United States

Location

1220.19.0014 Boehringer Ingelheim Investigational Site

New York, New York, United States

Location

1220.19.0084 Boehringer Ingelheim Investigational Site

New York, New York, United States

Location

1220.19.0021 Boehringer Ingelheim Investigational Site

Winston-Salem, North Carolina, United States

Location

1220.19.0013 Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

Location

1220.19.0029 Boehringer Ingelheim Investigational Site

Austin, Texas, United States

Location

1220.19.0012 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Location

1220.19.0060 Boehringer Ingelheim Investigational Site

Fort Worth, Texas, United States

Location

1220.19.0016 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Location

1220.19.0026 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

Location

1220.19.5508 Boehringer Ingelheim Investigational Site

Rio de Janeiro, Brazil

Location

1220.19.5502 Boehringer Ingelheim Investigational Site

Rio de Janeiro - RJ, Brazil

Location

1220.19.5506 Boehringer Ingelheim Investigational Site

Salvador, Brazil

Location

1220.19.5503 Boehringer Ingelheim Investigational Site

São Paulo, Brazil

Location

1220.19.5505 Boehringer Ingelheim Investigational Site

São Paulo, Brazil

Location

1220.19.5501 Boehringer Ingelheim Investigational Site

São Paulo - SP, Brazil

Location

1220.19.3306 Boehringer Ingelheim Investigational Site

Lyon, France

Location

1220.19.3303 Boehringer Ingelheim Investigational Site

Marseille, France

Location

1220.19.3304 Boehringer Ingelheim Investigational Site

Marseille, France

Location

1220.19.3301 Boehringer Ingelheim Investigational Site

Paris, France

Location

1220.19.3305 Boehringer Ingelheim Investigational Site

Paris, France

Location

1220.19.3307 Boehringer Ingelheim Investigational Site

Paris, France

Location

1220.19.4902 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1220.19.4921 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1220.19.4901 Boehringer Ingelheim Investigational Site

Bonn, Germany

Location

1220.19.4924 Boehringer Ingelheim Investigational Site

Frankfurt am Main, Germany

Location

1220.19.4919 Boehringer Ingelheim Investigational Site

Hamburg, Germany

Location

1220.19.4920 Boehringer Ingelheim Investigational Site

Hamburg, Germany

Location

1220.19.4905 Boehringer Ingelheim Investigational Site

München, Germany

Location

1220.19.4922 Boehringer Ingelheim Investigational Site

München, Germany

Location

1220.19.4923 Boehringer Ingelheim Investigational Site

Würzburg, Germany

Location

1220.19.3901 Boehringer Ingelheim Investigational Site

Antella (fi), Italy

Location

1220.19.3902 Boehringer Ingelheim Investigational Site

Bari, Italy

Location

1220.19.3906 Boehringer Ingelheim Investigational Site

Brescia, Italy

Location

1220.19.3907 Boehringer Ingelheim Investigational Site

Milan, Italy

Location

1220.19.3905 Boehringer Ingelheim Investigational Site

Pavia, Italy

Location

1220.19.3903 Boehringer Ingelheim Investigational Site

Roma, Italy

Location

1220.19.3904 Boehringer Ingelheim Investigational Site

Torino, Italy

Location

1220.19.3404 Boehringer Ingelheim Investigational Site

Badalona, Spain

Location

1220.19.3401 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1220.19.3403 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1220.19.3409 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1220.19.3402 Boehringer Ingelheim Investigational Site

L'Hospitalet de Llobregat, Spain

Location

1220.19.3405 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1220.19.3406 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1220.19.3407 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1220.19.3408 Boehringer Ingelheim Investigational Site

Seville, Spain

Location

1220.19.4101 Boehringer Ingelheim Investigational Site

Basel, Switzerland

Location

1220.19.4103 Boehringer Ingelheim Investigational Site

Bern, Switzerland

Location

1220.19.4102 Boehringer Ingelheim Investigational Site

Lugano, Switzerland

Location

1220.19.4104 Boehringer Ingelheim Investigational Site

Zurich, Switzerland

Location

1220.19.4406 Boehringer Ingelheim Investigational Site

Brighton, United Kingdom

Location

1220.19.4407 Boehringer Ingelheim Investigational Site

Edinburgh, United Kingdom

Location

1220.19.4401 Boehringer Ingelheim Investigational Site

London, United Kingdom

Location

1220.19.4402 Boehringer Ingelheim Investigational Site

London, United Kingdom

Location

1220.19.4403 Boehringer Ingelheim Investigational Site

London, United Kingdom

Location

1220.19.4404 Boehringer Ingelheim Investigational Site

London, United Kingdom

Location

1220.19.4408 Boehringer Ingelheim Investigational Site

London, United Kingdom

Location

1220.19.4405 Boehringer Ingelheim Investigational Site

Manchester, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 25710287 DERIVED

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

faldaprevir

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2011
• First Posted: July 22, 2011
• Study Start: September 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: June 1, 2014
• Last Updated: August 29, 2016
• Results First Posted: September 4, 2015

Record last verified: 2016-07

Locations

FR (6); US (22); GB (8); CH (4); BR (6); IT (7); ES (9); DE (9)