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)
2 other identifiers
interventional
549
13 countries
86
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 HIV
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2011
Typical duration for phase_3
86 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 4, 2011
CompletedFirst Posted
Study publicly available on registry
November 15, 2011
CompletedStudy Start
First participant enrolled
December 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedResults Posted
Study results publicly available
December 17, 2015
CompletedJanuary 29, 2016
December 1, 2015
2.5 years
November 4, 2011
August 18, 2015
December 22, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
SVR12 was defined as hepatitis C virus (HCV) values lower than the lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. HAART=highly active antiretroviral therapy. SVR12 was defined as hepatitis C virus (HCV) values lower than the lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. HAART=highly active antiretroviral therapy.
Follow-up Week 12
Secondary Outcomes (5)
Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Lower Than The Lower Limit of Quantitation (LLOQ), Target Detected (TD) or Target Not Detected (TND)
Week 1, 2, 4, 6, 8, 12 and at both Weeks 4 and 12; end of treatment; and follow-up Weeks 12 and 24
Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Lower Than the Lower Limit of Quantitation (LLOQ), Target Not Detected (TND)
Week 1, 2, 4, 6, 8, and 12 and at both Weeks 4 and 12; end of treatment; and follow-up Weeks 12 and 24
Percentage of Participants Who Received Highly Active Antiretroviral Therapy (HAART), Maintained HIV RNA <40 Copies/mL, and Experienced Confirmed HIV RNA ≥400 Copies/mL
End of treatment (up to Week 48)
Percentage of Participants With Sustained Virologic Response (SVR12) by rs12979860 Single Nucleotide Polymorphism (SNP) in the IL28B Gene
Follow-up Week 12
Number of Participants Who Died and With Serious Adverse Event (SAEs), Grade 3 to 4 Adverse Events (AEs), and AEs Leading to Discontinuation
From Day 1 to 7 days post last dose of study treatment (up to Week 48)
Study Arms (1)
Daclatsvir + Ribavirin + PEG-Interferon alfa-2a
EXPERIMENTALInterventions
Syringe, subcutaneous injection, 180 μg, once weekly, 24 or 48 weeks depending on response
Tablets; oral; 30, 60, or 90 mg; once daily; up to 24 weeks
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (86)
University Of Alabama At Birmingham
Birmingham, Alabama, 35294, United States
Scripps Clinic
La Jolla, California, 92037, United States
Southern California Permanente Medical Group
Los Angeles, California, 90027, United States
Desert Medical Group Inc.
Palm Springs, California, 92262, United States
Ucsd Antiviral Research Center
San Diego, California, 92103, United States
San Francisco Gen Hosp
San Francisco, California, 94110, United States
Kaiser Permanente Medical Center
San Francisco, California, 94118, United States
Va Connecticut Healthcare System
West Haven, Connecticut, 06516, United States
Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
University Of Miami School Of Medicine
Miami, Florida, 33136, United States
Orlando Immunology Center
Orlando, Florida, 32803, United States
Johns Hopkins University
Lutherville, Maryland, 21093, United States
Saint Michael'S Medical Center
Newark, New Jersey, 07102, United States
Upper Delaware Valley Infectious Diseases, Pc
Monticello, New York, 12701, United States
Icahn School Of Medicine At Mount Sinai
New York, New York, 10029, United States
Weill Cornell Medical College
New York, New York, 10065, United States
James J Peters Vamc
The Bronx, New York, 10468, United States
University Of North Carolina At Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Morehead Medical Plaza
Charlotte, North Carolina, 28204, United States
Amelia Court Hiv Research Clinic
Dallas, Texas, 75235, United States
Baylor College Of Medicine
Houston, Texas, 77030, United States
Texas Liver Institute
San Antonio, Texas, 78215, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
Local Institution
Buenos Aires, Buenos Aires, 1181, Argentina
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Buenos Aires, Buenos Aires, C1181, Argentina
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Ciudad de Buenos Aires, Buenos Aires, C1121ABE, Argentina
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Córdoba, Córdoba Province, 5000, Argentina
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Prov de Santa Fe, Santa Fe Province, 2000, Argentina
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Darlinghurst, New South Wales, 2010, Australia
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Darlinghurst Nsw, New South Wales, 2010, Australia
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Clayton, Victoria, 3168, Australia
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Parkville, Victoria, 3050, Australia
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Antwerp, 2000, Belgium
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Brussels, 1070, Belgium
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Brussels, B-1000, Belgium
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Rio de Janeiro, Rio de Janeiro, 20270, Brazil
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Rio de Janeiro, Rio de Janeiro, 21040, Brazil
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Porto Alegre, Rio Grande do Sul, 90035, Brazil
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São Paulo, São Paulo, 04035, Brazil
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Edmonton, Alberta, T6G 2B7, Canada
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Vancouver, British Columbia, V6Z 2C7, Canada
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Vancouver, British Columbia, V6Z 2K5, Canada
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Victoria, British Columbia, V8V 3P9, Canada
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Ottawa, Ontario, K1H 8L6, Canada
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Torono, Ontario, M5G 2N2, Canada
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Montreal, Quebec, H2L 4P9, Canada
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Montreal, Quebec, H2L 5B1, Canada
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Montreal, Quebec, H3A 1T1, Canada
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Marseille, 13274, France
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Montpellier, 34295, France
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Paris, 75013, France
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Paris, 75014, France
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Paris, 75018, France
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Paris, 75475, France
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Paris, 75571, France
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Pessac, 33604, France
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Berlin, 13353, Germany
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Bonn, 53105, Germany
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Frankfurt, 60590, Germany
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Frankfurt am Main, 60311, Germany
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Hamburg, 20146, Germany
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Brescia, 25123, Italy
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Milan, 20127, Italy
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Milan, 20162, Italy
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Modena, 41100, Italy
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Torino, 10149, Italy
Fundacion De Investigacion De Diego
San Juan, 00927, Puerto Rico
University Of Puerto Rico School Of Medicine
San Juan, 00935, Puerto Rico
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Kaluga, 248023, Russia
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Lipetsk, 398043, Russia
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Moscow, 111123, Russia
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Nizhny Novgorod, 603005, Russia
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Saint Petersburg, 190103, Russia
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Saint Petersburg, 191167, Russia
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Saint Petersburg, 196645, Russia
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Saratov, 410009, Russia
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Volgograd, 400040, Russia
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Badalona, Barcelona, 08916, Spain
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Barcelona, 08003, Spain
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Córdoba, 14004, Spain
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Madrid, 28007, Spain
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Madrid, 28040, Spain
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Madrid, 28041, Spain
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Madrid, 28046, Spain
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Seville, 41014, Spain
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London, Greater London, SW10 9NH, United Kingdom
Related Publications (1)
Sulkowski MS, Fessel WJ, Lazzarin A, Berenguer J, Zakharova N, Cheinquer H, Cote P, Dieterich D, Gadano A, Matthews G, Molina JM, Moreno C, Pineda JA, Pulido F, Rivero A, Rockstroh J, Hernandez D, McPhee F, Eley T, Liu Z, Mendez P, Hughes E, Noviello S, Ackerman P. Efficacy and safety of daclatasvir plus pegylated-interferon alfa 2a and ribavirin in previously untreated HCV subjects coinfected with HIV and HCV genotype-1: a Phase III, open-label study. Hepatol Int. 2017 Mar;11(2):188-198. doi: 10.1007/s12072-017-9788-z. Epub 2017 Feb 16.
PMID: 28210927DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 4, 2011
First Posted
November 15, 2011
Study Start
December 1, 2011
Primary Completion
June 1, 2014
Study Completion
September 1, 2014
Last Updated
January 29, 2016
Results First Posted
December 17, 2015
Record last verified: 2015-12