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 is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01471574
First received: November 4, 2011
Last updated: January 23, 2014
Last verified: January 2014
  Purpose

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 ]

Estimated Enrollment: 300
Study Start Date: December 2011
Estimated Study Completion Date: September 2014
Estimated 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®

  Eligibility

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

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01471574

  Hide Study Locations
Locations
United States, Alabama
University Of Alabama At Birmingham
Birmingham, Alabama, United States, 35294-2170
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 General Hospital
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
Mount Sinai School Of Medicine
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, 27599-7584
Morehead Medical Plaza
Charlotte, North Carolina, United States, 28204
United States, Texas
Ut Southwestern Medical Center
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, 23298-0341
Argentina
Local Institution
Ciudad De Buenos Aires, Buenos Aires, Argentina, C1121ABE
Local Institution
Prov De Santa Fe, Santa Fe, Argentina, 2000
Local Institution
Buenos Aires, Argentina, C1181
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Buenos Aires, Argentina, 1181
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Cordoba, Argentina, 5000
Australia, New South Wales
Local Institution
Darlinghurst, New South Wales, Australia, 2010
Local Institution
Darlinghurst Nsw, New South Wales, Australia, 2010
Australia, Victoria
Local Institution
Clayton, Victoria, Australia, 3168
Local Institution
Parville, Victoria, Australia, 3050
Belgium
Local Institution
Antwerpen, Belgium, 2000
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Brussels, Belgium, 1070
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Bruxelles, Belgium, 1000
Brazil
Local Institution
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-003
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Rio De Janeiro, Brazil, 20270-004
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Rio De Janeiro, Brazil, 21040-000
Local Institution
Sao Paulo, Brazil, 04035-970
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
Local Institution
Ottawa, Ontario, Canada, K1H 8L6
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Toronto, Ontario, Canada, M5G 2N2
Canada, Quebec
Local Institution
Montreal, Quebec, Canada, H3A 1T1
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Montreal, Quebec, Canada, H2L 4P9
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Montreal, Quebec, Canada, H2L 5B1
France
Local Institution
Marseille Cedex 09, France, 13274
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Montpellier Cedex 5, France, 34295
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Paris, France, 75018
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Paris, France, 75014
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Paris, France, 75571
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Paris, France, 75013
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Paris Cedex 10, France, 75475
Local Institution
Pessac Cedex, France, 33604
Germany
Local Institution
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
Local Institution
Hamburg, Germany, 20146
Italy
Local Institution
Brescia, Italy, 25123
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Milano, Italy, 20162
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Milano, Italy, 20127
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Modena, Italy, 41100
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Torino, Italy, 10149
Puerto Rico
Local Institution
San Juan, Puerto Rico, 00927
Local Institution
San Juan, Puerto Rico, 00935
Russian Federation
Local Institution
Kaluga, Russian Federation, 248023
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Lipetsk, Russian Federation, 398043
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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
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St.petersburg, Russian Federation, 190103
Local Institution
Volgograd, Russian Federation, 400040
Spain
Local Institution
Barcelona, Spain, 08003
Local Institution
Barcelona, Spain, 08916
Local Institution
Cordoba, Spain, 14004
Local Institution
Madrid, Spain, 28007
Local Institution
Madrid, Spain, 28041
Local Institution
Madrid, Spain, 28040
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
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01471574     History of Changes
Other Study ID Numbers: AI444-043, 2011-003067-30
Study First Received: November 4, 2011
Last Updated: January 23, 2014
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
Hepatitis A
Hepatitis C
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Flaviviridae Infections
Interferon-alpha
Interferon Alfa-2a
Interferons
Ribavirin
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors

ClinicalTrials.gov processed this record on April 17, 2014