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)

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 310 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	PegIFN/RBV	PegIFN/RBV for 24 or 48w
DRUG	PegIFN/RBV	PegIFN/RBV for 24 or 48w
DRUG	BI201335	BI201335 for 12w
DRUG	BI201335 24W	BI201335 for 24w
DRUG	PegIFN/RBV	PegIFN/RBV for 24 or 48w
DRUG	Bi 201335	BI 201335 for 24 w

Timeline

• Start date: 2011-09-01
• Primary completion: 2013-09-01
• Completion: 2014-06-01
• First posted: 2011-07-22
• Last updated: 2016-08-29
• Results posted: 2015-09-04

Locations

71 sites across 8 countries: United States, Brazil, France, Germany, Italy, Spain, Switzerland, United Kingdom