NCT01471574

Safety and Efficacy Study of Daclatasvir (BMS-790052) Plus Pegylated Interferon-Alfa 2a and Ribavirin in Patients Coinfected With Untreated Hepatitis C Virus and HIV Virus

A Phase 3, Open Label Study of Safety and Efficacy With BMS-790052 Plus Peg-Interferon Alfa 2a and Ribavirin in Previously Untreated HCV Patients Coinfected With Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 549 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this open label study is to evaluate the safety and efficacy of daclatasvir plus pegylated interferon-alfa 2a and ribavirin in untreated hepatitis C virus in patients coinfected with HIV

Conditions

• Hepatitis C, Genotype 1

Interventions

Type	Name	Description
DRUG	Daclatasvir	Tablets; oral; 30, 60, or 90 mg; once daily; up to 24 weeks
DRUG	Ribavirin	Tablets; oral; for patients weighing \<75 kg, the total dose is 1000 mg per day (2 200-mg tablets in the morning and 3 200-mg tablets in the evening); for patients weighing \>75 kg, the total dose is 1200 mg per day (3 200-mg tablets in morning and 3 200-mg tablets in evening); twice daily with food; 24 or 48 weeks depending on response
DRUG	PEG-Interferon alfa 2a	Syringe, subcutaneous injection, 180 μg, once weekly, 24 or 48 weeks depending on response

Timeline

• Start date: 2011-12-01
• Primary completion: 2014-06-01
• Completion: 2014-09-01
• First posted: 2011-11-15
• Last updated: 2016-01-29
• Results posted: 2015-12-17

Locations

86 sites across 13 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, France, Germany, Italy, Puerto Rico, Russia, Spain, United Kingdom