Status:
COMPLETED
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
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Hepatitis C, Genotype 1
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief 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 HI...
Eligibility Criteria
Inclusion
- For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
- Key
- Males and females, 18 to 70 years of age
- Hepatitis C virus (HCV) genotype 1a or 1b
- HCV-treatment naive
- HCV RNA \>10,000 IU/mL at screening
- HIV-1 infection (approximately 250 patients receiving highly active antiretroviral therapy \[HAART\], up to 50 patients not receiving HAART)
- For patients receiving HAART, HIV RNA must be below \<40 copies/mL at screening and must be \<400 copies/ml for at least 6 months prior to screening
- Key
Exclusion
- Patients receiving HAART who first initiated antiretroviral therapy within the last 6 months of Day 1
- Patients receiving HAART who have changed their antiretroviral regimen due to safety or efficacy associated to HIV treatment within the last 3 months prior to Day 1. However, if changes are required to a patient's HAART regimen to meet the requirements of the protocol, these changes are allowed at the screening visit. The patient should wait a minimum of 1 month prior to Day 1 after a repeat of HIV viral load has been confirmed, \<40 copies/ mL
- Use of prohibited HAART regimens within 1 month of Day 1 and throughout the treatment period of the trial (patients receiving HAART who have changed their antiretroviral regimen to initiate any HCV treatment within 6 weeks prior to Day 1)
- Laboratory values:
- Neutrophil count \<1500 cells/μL (\<1200 cells/ μL for Blacks)
- Platelet count \<90,000 cells/μL
- Hemoglobin ≤12 g/dL for females, hemoglobin ≤13 g/dL for males
- Total bilirubin ≥34 μmol/L (or ≥2 mg/dL) unless a patient has a documented history of Gilbert's disease or antiretroviral regimen contains atazanavir
- Alanine aminotransferase ≥5\*upper limit of normal
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
549 Patients enrolled
Trial Details
Trial ID
NCT01471574
Start Date
December 1 2011
End Date
September 1 2014
Last Update
January 29 2016
Active Locations (86)
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1
University Of Alabama At Birmingham
Birmingham, Alabama, United States, 35294
2
Scripps Clinic
La Jolla, California, United States, 92037
3
Southern California Permanente Medical Group
Los Angeles, California, United States, 90027
4
Desert Medical Group Inc.
Palm Springs, California, United States, 92262