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)
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ClinicalTrials.gov Identifier: NCT01399619 |
Recruitment Status
:
Completed
First Posted
: July 22, 2011
Results First Posted
: September 4, 2015
Last Update Posted
: August 29, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hepatitis C, Chronic | Drug: PegIFN/RBV Drug: BI201335 Drug: BI201335 24W Drug: Bi 201335 | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 310 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 Start Date : | September 2011 |
Actual Primary Completion Date : | September 2013 |
Actual Study Completion Date : | June 2014 |
Arm | Intervention/treatment |
---|---|
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
|
Drug: PegIFN/RBV
PegIFN/RBV for 24 or 48w
Drug: BI201335
BI201335 for 12w
|
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
|
Drug: BI201335 24W
BI201335 for 24w
Drug: PegIFN/RBV
PegIFN/RBV for 24 or 48w
|
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
|
Drug: PegIFN/RBV
PegIFN/RBV for 24 or 48w
Drug: Bi 201335
BI 201335 for 24 w
|
- 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.
- 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.

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01399619

Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim |
Additional Information:
Responsible Party: | Boehringer Ingelheim |
ClinicalTrials.gov Identifier: | NCT01399619 History of Changes |
Other Study ID Numbers: |
1220.19 2010-021734-59 ( EudraCT Number: EudraCT ) |
First Posted: | July 22, 2011 Key Record Dates |
Results First Posted: | September 4, 2015 |
Last Update Posted: | August 29, 2016 |
Last Verified: | July 2016 |
Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome HIV Infections Hepatitis Hepatitis A Hepatitis C Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections |
Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Hepatitis, Chronic Lentivirus Infections Retroviridae Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases |