Safety and Efficacy Study of BMS-790052 Plus Peg-Interferon Alfa 2a and Ribavirin in Untreated Hepatitis C Patients Coinfected With HIV Virus

This study has been completed.
Information provided by (Responsible Party):
Bristol-Myers Squibb Identifier:
First received: November 4, 2011
Last updated: February 6, 2015
Last verified: July 2014
The purpose of this open label study is to evaluate the safety and efficacy of BMS-790052 plus Peg-Interferon Alfa 2a and Ribavirin in untreated Hepatitis C Patients Coinfected with HIV Virus compared to historic controls

Condition Intervention Phase
Hepatitis C, Genotype 1
Drug: BMS-790052 (Daclatasvir)
Drug: Ribavirin
Drug: Peg-Interferon alfa 2a
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Proportion of subjects with SVR12, defined as HCV RNA < LLOQ, target detected or not detected at post-treatment Week 12 [ Time Frame: Follow up Week 12 ] [ Designated as safety issue: No ]
    • SVR12 = Sustained virologic response at follow up Week 12
    • HCV RNA = Hepatitis C virus ribonucleic acid
    • LLOQ = Lower Limit of quantitation

Secondary Outcome Measures:
  • Proportion of subjects with Genotype 1 infection who achieve HCV RNA < LLOQ , target detected or not detected [ Time Frame: On-treatment Weeks 1, 2, 4, 6, 8 and 12; at both weeks 4 and 12; EOT; post-treatment Week 24 (SVR24) and post-treatment Week 48 (SVR48) for subjects who achieve VR (4 & 12) ] [ Designated as safety issue: No ]
    • EOT = End of treatment
    • VR = virologic response

  • Proportion of subjects with Genotype 1 infection who achieve HCV RNA < LLOQ, target not detected [ Time Frame: On-treatment Weeks 1, 2, 4, 6, 8 and 12; at both weeks 4 and 12; EOT; post-treatment Week 12; post-treatment Week 24; and post-treatment Week 48 for subjects who achieve VR (4 & 12) ] [ Designated as safety issue: No ]
  • Safety, as measured by the frequency of SAEs and discontinuations due to AEs [ Time Frame: Maximum of 48 weeks ] [ Designated as safety issue: Yes ]
    • SAEs = Serious Adverse Events
    • AEs = Adverse Events

  • Proportion of subjects who are receiving HAART and who maintain their HIV RNA < 40 copies/mL and the proportion of subjects who experience confirmed HIV RNA ≥ 400 copies/mL at end of treatment for subjects who are receiving HAART [ Time Frame: End of treatment (maximum of 48 weeks) ] [ Designated as safety issue: Yes ]
    HAART = Highly active antiretroviral therapy

  • Proportion of subjects with SVR12 by rs12979860 Single nucleotide polymorphism (SNP) in the IL28B gene [ Time Frame: Post-treatment Week 12 ] [ Designated as safety issue: No ]

Enrollment: 301
Study Start Date: December 2011
Study Completion Date: September 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BMS-790052 (Daclatasvir) + Ribavirin + Peg-Interferon alfa-2a Drug: BMS-790052 (Daclatasvir)
Tablets, Oral, 30 mg; 60 mg; or 90 mg, Once daily, Up to 24 weeks
Drug: Ribavirin
Tablets, Oral, for subjects weighing < 75 kg, the total dose is 1000 mg per day (two 200 mg tablets in the morning and three 200 mg tablets in the evening); for subjects weighing > 75 kg, the total dose is 1200 mg per day (three 200 mg tablets in morning and three 200 mg tablets in evening), Twice daily with food, 24 or 48 weeks depending on response
Other Name: Copegus®
Drug: Peg-Interferon alfa 2a
Syringe, Subcutaneous Injection, 180 μg, once weekly, 24 or 48 weeks depending on response
Other Name: Pegasys®


Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

For more information regarding BMS clinical trial participation, please visit

Inclusion Criteria:

  • Males and females, 18 to 70 years of age
  • HCV Genotype 1a or 1b
  • HCV-Treatment naive
  • HCV RNA > 10,000 IU/mL at screening
  • HIV-1 infection;(approximately 250 subjects receiving HAART, up to 50 subjects not receiving HAART)
  • For subjects 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:

  • Subjects (receiving HAART) who had first initiated anti-retroviral therapy within the last 6 months of Day 1
  • Subjects (receiving HAART) who have changed their anti-retroviral 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 subject's HAART regimen to meet the requirements of the protocol, these changes are allowed at the screening visit. Subject 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 one month of Day 1 and throughout the treatment period of the trial (Subjects receiving HAART who have changed their anti-retroviral 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 subject has a documented history of Gilbert's disease or antiretroviral regimen contains Atazanavir
    5. Alanine aminotransferase (ALT) ≥ 5 x Upper limit of normal (ULN)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01471574

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United States, Alabama
University Of Alabama At Birmingham
Birmingham, Alabama, United States, 35294
United States, California
Scripps Clinic
La Jolla, California, United States, 92037
Southern California Permanente Medical Group
Los Angeles, California, United States, 90027
Desert Medical Group Inc.
Palm Springs, California, United States, 92262
Ucsd Antiviral Research Center
San Diego, California, United States, 92103
Kaiser Permanente Medical Center
San Francisco, California, United States, 94118
San Francisco Gen Hosp
San Francisco, California, United States, 94110
United States, Connecticut
Va Connecticut Healthcare System
West Haven, Connecticut, United States, 06516
United States, District of Columbia
Georgetown University Hospital
Washington, District of Columbia, United States, 20007
United States, Florida
University Of Miami School Of Medicine
Miami, Florida, United States, 33136
Orlando Immunology Center
Orlando, Florida, United States, 32803
United States, Maryland
Johns Hopkins University
Lutherville, Maryland, United States, 21093
United States, New Jersey
Saint Michael'S Medical Center
Newark, New Jersey, United States, 07102
United States, New York
James J Peters Vamc
Bronx, New York, United States, 10468
Upper Delaware Valley Infectious Diseases, Pc
Monticello, New York, United States, 12701
Icahn School Of Medicine At Mount Sinai
New York, New York, United States, 10029
Weill Cornell Medical College
New York, New York, United States, 10065
United States, North Carolina
University Of North Carolina At Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Morehead Medical Plaza
Charlotte, North Carolina, United States, 28204
United States, Texas
Amelia Court Hiv Research Clinic
Dallas, Texas, United States, 75235
Baylor College Of Medicine
Houston, Texas, United States, 77030
Texas Liver Institute
San Antonio, Texas, United States, 78215
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Local Institution
Ciudad De Buenos Aires, Buenos Aires, Argentina, C1121ABE
Local Institution
Prov De Santa Fe, Santa Fe, Argentina, 2000
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Buenos Aires, Argentina, 1181
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Buenos Aires, Argentina, C1181
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Cordoba, Argentina, 5000
Australia, New South Wales
Local Institution
Darlinghurst, New South Wales, Australia, 2010
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Darlinghurst Nsw, New South Wales, Australia, 2010
Australia, Victoria
Local Institution
Clayton, Victoria, Australia, 3168
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Parkville, Victoria, Australia, 3050
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Antwerpen, Belgium, 2000
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Brussels, Belgium, 1070
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Brussels, Belgium, B-1000
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Porto Alegre, Rio Grande Do Sul, Brazil, 90035
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Rio De Janeiro, Brazil, 20270
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Rio De Janeiro, Brazil, 21040
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Sao Paulo, Brazil, 04035
Canada, Alberta
Local Institution
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
Local Institution
Vancouver, British Columbia, Canada, V6Z 2C7
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Vancouver, British Columbia, Canada, V6Z 2K5
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Victoria, British Columbia, Canada, V8V 3P9
Canada, Ontario
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Ottawa, Ontario, Canada, K1H 8L6
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Torono, Ontario, Canada, M5G 2N2
Canada, Quebec
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Montreal, Quebec, Canada, H2L 4P9
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Montreal, Quebec, Canada, H2L 5B1
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Montreal, Quebec, Canada, H3A 1T1
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Marseille Cedex 09, France, 13274
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Montpellier Cedex 5, France, 34295
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Paris, France, 75013
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Paris, France, 75014
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Paris, France, 75018
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Paris, France, 75571
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Paris Cedex 10, France, 75475
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Pessac Cedex, France, 33604
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Berlin, Germany, 13353
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Bonn, Germany, 53105
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Frankfurt, Germany, 60590
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Frankfurt Am Main, Germany, 60311
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Hamburg, Germany, 20146
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Brescia, Italy, 25123
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Milano, Italy, 20127
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Milano, Italy, 20162
Local Institution
Modena, Italy, 41100
Local Institution
Torino, Italy, 10149
Puerto Rico
Fundacion De Investigacion De Diego
San Juan, Puerto Rico, 00927
University Of Puerto Rico School Of Medicine
San Juan, Puerto Rico, 00935
Russian Federation
Local Institution
Kaluga, Russian Federation, 248023
Local Institution
Lipetsk, Russian Federation, 398043
Local Institution
Moscow, Russian Federation, 111123
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Nizhniy Novgorod, Russian Federation, 603005
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Saratov, Russian Federation, 410009
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St. Petersburg, Russian Federation, 191167
Local Institution
St. Petersburg, Russian Federation, 196645
Local Institution
St.petersburg, Russian Federation, 190103
Local Institution
Volgograd, Russian Federation, 400040
Local Institution
Badalona, Barcelona, Spain, 08916
Local Institution
Barcelona, Spain, 08003
Local Institution
Cordoba, Spain, 14004
Local Institution
Madrid, Spain, 28007
Local Institution
Madrid, Spain, 28040
Local Institution
Madrid, Spain, 28041
Local Institution
Madrid, Spain, 28046
Local Institution
Sevilla, Spain, 41014
United Kingdom
Local Institution
London, Greater London, United Kingdom, SW10 9NH
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb Identifier: NCT01471574     History of Changes
Other Study ID Numbers: AI444-043, 2011-003067-30
Study First Received: November 4, 2011
Last Updated: February 6, 2015
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Australia: Department of Health and Ageing Therapeutic Goods Administration
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Italy: Ministry of Health
Italy: National Bioethics Committee
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Italy: The Italian Medicines Agency
Spain: Spanish Agency of Medicines
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Russia: Ethics Committee
Russia: Ministry of Health of the Russian Federation
Brazil: National Health Surveillance Agency
Brazil: National Committee of Ethics in Research
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Hepatitis A
Hepatitis C
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Peginterferon alfa-2a
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action processed this record on November 27, 2015