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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01399619
First received: July 20, 2011
Last updated: July 28, 2016
Last verified: July 2016
July 20, 2011
July 28, 2016
September 2011
September 2013   (Final data collection date for primary outcome measure)
Sustained Virological Response (SVR12) [ Time Frame: 60 weeks ]
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.
Sustained Virological Response (SVR): Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) level <25 IU/mL, undetected 24 weeks after the planned treatment duration. [ Time Frame: 72 weeks ]
Complete list of historical versions of study NCT01399619 on ClinicalTrials.gov Archive Site
  • Virological Response 24 Weeks Post Treatment (SVR24) [ Time Frame: 72 weeks ]
    Percentage of participants with virological response 24 weeks post treatment (SVR24): Plasma HCV RNA level<25IU/mL (undetected) 24 weeks after the planned end of treatment.
  • Early Treatment Success (ETS) [ Time Frame: Week 4, week 8 and week 60 ]
    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
  • The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment (EoT) When SVR12=Yes [ Time Frame: 48 weeks ]
    The number of participants with Alanine Aminotransferase (ALT) normalisation at End of Treatment (EoT) when SVR12=yes. BL stands for baseline.
  • The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment When SVR12=no [ Time Frame: 48 weeks ]
    The number of participants with Alanine Aminotransferase (ALT) normalisation: ALT in normal range at End of Treatment when SVR12=no. BL stands for baseline.
  • The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=Yes [ Time Frame: 60 weeks ]
    The number of participants with ALT in normal range at post treatment (SVR12 Visit) when SVR12=yes. BL = baseline.
  • The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=no [ Time Frame: 60 weeks ]
    The number of participants with ALT in normal range at post treatment (SVR12 Visit) when SVR12=no. BL = baseline.
  • The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=Yes [ Time Frame: 48 weeks ]
    The number of participants with Aspartate Aminotransferase (AST) normalisation at End of Treatment when SVR12=yes. BL = baseline.
  • The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=no [ Time Frame: 48 weeks ]
    The number of participants with Aspartate Aminotransferase (AST) normalisation at End of Treatment when SVR12=no. BL = baseline.
  • The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=Yes [ Time Frame: 60 weeks ]
    The number of participants with AST in normal range at Post Treatment (SVR12 Visit) when SVR12=yes. BL = baseline.
  • The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=no [ Time Frame: 60 weeks ]
    The number of participants with AST in normal range at Post Treatment (SVR12 Visit) when SVR12=no. BL = baseline.
  • Virological response after 12 weeks of treattment discontinuation (SVR12): Plasma HCV RNA level<25IU/mL (undetected) 12 weeks after the originally planned treatment duration . [ Time Frame: 60 weeks ]
  • 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 ]
  • Alanine Aminotransferase normalisation: Alanine Aminotransferase in normal range 24 weeks after the end of the originally planned treatment duration [ Time Frame: 48 weeks ]
Not Provided
Not Provided
 
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)
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.
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
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis C, Chronic
  • Drug: PegIFN/RBV
    PegIFN/RBV for 24 or 48w
  • Drug: BI201335
    BI201335 for 12w
  • Drug: BI201335 24W
    BI201335 for 24w
  • Drug: Bi 201335
    BI 201335 for 24 w
  • 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
    Interventions:
    • Drug: PegIFN/RBV
    • Drug: BI201335
  • 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
    Interventions:
    • Drug: BI201335 24W
    • Drug: PegIFN/RBV
  • 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
    Interventions:
    • Drug: PegIFN/RBV
    • Drug: Bi 201335
Dieterich D, Nelson M, Soriano V, Arastéh K, Guardiola JM, Rockstroh JK, Bhagani S, Laguno M, Tural C, Ingiliz P, Jain MK, Stern JO, Manero M, Vinisko R, Kort J; the STARTVerso4 study group. STARTVerso4: faldaprevir and pegylated interferon α-2a/ribavirin in individuals co-infected with hepatitis C virus genotype-1 and HIV. AIDS. 2015 Jan 21. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
310
June 2014
September 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Brazil,   France,   Germany,   Italy,   Spain,   Switzerland,   United Kingdom,   United States
 
 
NCT01399619
1220.19
2010-021734-59 ( EudraCT Number: EudraCT )
Not Provided
Not Provided
Not Provided
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP