CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 549 enrolled
Drug / intervention
Daclatasvir +2 moredrug
Likely dose
Daclatasvir 90 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01471574
NCT01471574Phase 3Completed
CompareCT.gov

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)

Bristol-Myers Squibb·interventional·Posted Nov 15, 2011·Updated Jan 29, 2016

In Brief

A Phase 3 clinical trial evaluating Daclatasvir, Ribavirin, and 1 other intervention for Hepatitis C, Genotype 1. Completed, enrolled 549 participants across 86 sites in 13 countries.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C, Genotype 1
CountriesArgentina, Australia, Belgium, Brazil, Canada, France, Germany, Italy, Puerto Rico, Russia, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 15, 2011
Enrollment StartDec 1, 2011
Primary CompletionJun 1, 2014
Study CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 14.6 years ago

Interventions

Daclatasvirdrug

Tablets; oral; 30, 60, or 90 mg; once daily; up to 24 weeks

Ribavirindrug

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

PEG-Interferon alfa 2adrug

Syringe, subcutaneous injection, 180 μg, once weekly, 24 or 48 weeks depending on response