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
NCT ID: NCT01471574
Last Updated: 2016-01-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
549 participants
INTERVENTIONAL
2011-12-31
2014-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Daclatsvir + Ribavirin + PEG-Interferon alfa-2a
Daclatasvir
Tablets; oral; 30, 60, or 90 mg; once daily; up to 24 weeks
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
PEG-Interferon alfa 2a
Syringe, subcutaneous injection, 180 μg, once weekly, 24 or 48 weeks depending on response
Interventions
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Daclatasvir
Tablets; oral; 30, 60, or 90 mg; once daily; up to 24 weeks
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
PEG-Interferon alfa 2a
Syringe, subcutaneous injection, 180 μg, once weekly, 24 or 48 weeks depending on response
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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:
1. Neutrophil count \<1500 cells/μL (\<1200 cells/ μL for Blacks)
2. Platelet count \<90,000 cells/μL
3. Hemoglobin ≤12 g/dL for females, hemoglobin ≤13 g/dL for males
4. 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
5. Alanine aminotransferase ≥5\*upper limit of normal
18 Years
70 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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University Of Alabama At Birmingham
Birmingham, Alabama, United States
Scripps Clinic
La Jolla, California, United States
Southern California Permanente Medical Group
Los Angeles, California, United States
Desert Medical Group Inc.
Palm Springs, California, United States
Ucsd Antiviral Research Center
San Diego, California, United States
San Francisco Gen Hosp
San Francisco, California, United States
Kaiser Permanente Medical Center
San Francisco, California, United States
Va Connecticut Healthcare System
West Haven, Connecticut, United States
Georgetown University Hospital
Washington D.C., District of Columbia, United States
University Of Miami School Of Medicine
Miami, Florida, United States
Orlando Immunology Center
Orlando, Florida, United States
Johns Hopkins University
Lutherville, Maryland, United States
Saint Michael'S Medical Center
Newark, New Jersey, United States
Upper Delaware Valley Infectious Diseases, Pc
Monticello, New York, United States
Icahn School Of Medicine At Mount Sinai
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
James J Peters Vamc
The Bronx, New York, United States
University Of North Carolina At Chapel Hill
Chapel Hill, North Carolina, United States
Morehead Medical Plaza
Charlotte, North Carolina, United States
Amelia Court Hiv Research Clinic
Dallas, Texas, United States
Baylor College Of Medicine
Houston, Texas, United States
Texas Liver Institute
San Antonio, Texas, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Local Institution
Buenos Aires, Buenos Aires, Argentina
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Buenos Aires, Buenos Aires, Argentina
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Ciudad de Buenos Aires, Buenos Aires, Argentina
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Córdoba, Córdoba Province, Argentina
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Prov de Santa Fe, Santa Fe Province, Argentina
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Darlinghurst, New South Wales, Australia
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Darlinghurst Nsw, New South Wales, Australia
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Clayton, Victoria, Australia
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Parkville, Victoria, Australia
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Antwerp, , Belgium
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Brussels, , Belgium
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Brussels, , Belgium
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Rio de Janeiro, Rio de Janeiro, Brazil
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Rio de Janeiro, Rio de Janeiro, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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São Paulo, São Paulo, Brazil
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Edmonton, Alberta, Canada
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Vancouver, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Victoria, British Columbia, Canada
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Ottawa, Ontario, Canada
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Torono, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Marseille, , France
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Montpellier, , France
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Paris, , France
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Paris, , France
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Paris, , France
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Paris, , France
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Paris, , France
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Pessac, , France
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Berlin, , Germany
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Bonn, , Germany
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Frankfurt, , Germany
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Frankfurt am Main, , Germany
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Hamburg, , Germany
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Brescia, , Italy
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Milan, , Italy
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Milan, , Italy
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Modena, , Italy
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Torino, , Italy
Fundacion De Investigacion De Diego
San Juan, , Puerto Rico
University Of Puerto Rico School Of Medicine
San Juan, , Puerto Rico
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Kaluga, , Russia
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Lipetsk, , Russia
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Moscow, , Russia
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Nizhny Novgorod, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saratov, , Russia
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Volgograd, , Russia
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Badalona, Barcelona, Spain
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Barcelona, , Spain
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Córdoba, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Seville, , Spain
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London, Greater London, United Kingdom
Countries
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References
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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.
Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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2011-003067-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AI444-043
Identifier Type: -
Identifier Source: org_study_id
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