NCT01866930

Efficacy and Safety Study of Pegylated Interferon Lambda-1a With Ribavirin and Daclatasvir, to Treat naïve Subjects With Chronic HCV Genotypes 1, 2, 3, and 4 Who Are Co-infected With HIV

Phase 3 Open Label Study Evaluating the Efficacy and Safety of Pegylated Interferon Lambda-1a, in Combination With Ribavirin and Daclatasvir, for Treatment of Chronic HCV Infection With Treatment naïve Genotypes 1, 2, 3 or 4 in Subjects Co-infected With HIV

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 453 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate Sustained Virologic Response at post treatment Week 12 (SVR12)following treatment with Lambda/RBV/DCV in chronic HCV GT-1, -2, -3 or -4 subjects co-infected with HIV-1

Detailed description

Study Classification: Safety/Efficacy and Pharmacokinetics/dynamics GT=genotype

Conditions

• Chronic Hepatitis C Infection

Interventions

Type	Name	Description
BIOLOGICAL	Pegylated Interferon Lambda-1a
DRUG	Daclatasvir (DCV)
DRUG	Ribasphere (RBV)

Timeline

• Start date: 2013-07-11
• Primary completion: 2015-08-27
• Completion: 2015-08-27
• First posted: 2013-06-03
• Last updated: 2023-06-13
• Results posted: 2023-06-13

Locations

63 sites across 12 countries: United States, Argentina, Belgium, Canada, France, Germany, Italy, Mexico, Poland, Russia, Spain, United Kingdom