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Completed

NCT Number: 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)

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

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

1220.19.5508 Boehringer Ingelheim Investigational Site, Rio de Janeiro, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PegIFN/RBV

Drug

PegIFN/RBV for 24 or 48w

BI201335

Drug

BI201335 for 12w

BI201335 24W

Drug

BI201335 for 24w

BI 201335

Drug

BI 201335 for 24 w

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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.

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Jul 22, 2011
Registry last updated
Aug 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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