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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01471574
First received: November 4, 2011
Last updated: December 22, 2015
Last verified: December 2015
  Purpose
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

Condition Intervention Phase
Hepatitis C, Genotype 1
Drug: 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:
  • Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) [ Time Frame: Follow-up Week 12 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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) [ Time Frame: Week 1, 2, 4, 6, 8, 12 and at both Weeks 4 and 12; end of treatment; and follow-up Weeks 12 and 24 ] [ Designated as safety issue: No ]
    Participants who achieved HCV RNA levels lower than the LLOQ i.e., 25 IU/ml, TD or TND. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. HAART=highly active antiretroviral therapy.

  • Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Lower Than the Lower Limit of Quantitation (LLOQ), Target Not Detected (TND) [ Time Frame: 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 ] [ Designated as safety issue: No ]
    Participants who achieved HCV RNA levels lower than the LLOQ, TND. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. HAART=highly active antiretroviral therapy.

  • Percentage of Participants Who Received Highly Active Antiretroviral Therapy (HAART), Maintained HIV RNA <40 Copies/mL, and Experienced Confirmed HIV RNA ≥400 Copies/mL [ Time Frame: End of treatment (up to Week 48) ] [ Designated as safety issue: No ]
    Participants who received HAART, maintained HIV RNA <40 copies/mL, and experienced confirmed HIV RNA ≥ 400 copies/mL were determined.

  • Percentage of Participants With Sustained Virologic Response (SVR12) by rs12979860 Single Nucleotide Polymorphism (SNP) in the IL28B Gene [ Time Frame: Follow-up Week 12 ] [ Designated as safety issue: No ]
    Percentages calculated as number of responders/number who received treatment.

  • Number of Participants Who Died and With Serious Adverse Event (SAEs), Grade 3 to 4 Adverse Events (AEs), and AEs Leading to Discontinuation [ Time Frame: From Day 1 to 7 days post last dose of study treatment (up to Week 48) ] [ Designated as safety issue: Yes ]
    Adverse event was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threating, an important medical event, or a congenital anomaly/birth defect; or required prolonged hospitalization. HAART=highly active antiretroviral therapy.


Enrollment: 549
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: Daclatsvir + Ribavirin + PEG-Interferon alfa-2a Drug: Daclatasvir
Tablets; oral; 30, 60, or 90 mg; once daily; up to 24 weeks
Other Name: BMS-790052
Drug: 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
Other Name: Copegus®
Drug: PEG-Interferon alfa 2a
Syringe, subcutaneous injection, 180 μg, once weekly, 24 or 48 weeks depending on response
Other Names:
  • Pegasys®
  • Pegylated interferon

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

Key Inclusion Criteria:

  • 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 Criteria:

  • 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:

    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
  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 ClinicalTrials.gov identifier: NCT01471574

  Hide Study Locations
Locations
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
San Francisco Gen Hosp
San Francisco, California, United States, 94110
Kaiser Permanente Medical Center
San Francisco, California, United States, 94118
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
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, 1181
Local Institution
Buenos Aires, Argentina, C1181
Local Institution
Cordoba, Argentina, 5000
Australia, New South Wales
Local Institution
Darlinghurst Nsw, New South Wales, Australia, 2010
Local Institution
Darlinghurst, New South Wales, Australia, 2010
Australia, Victoria
Local Institution
Clayton, Victoria, Australia, 3168
Local Institution
Parkville, Victoria, Australia, 3050
Belgium
Local Institution
Antwerpen, Belgium, 2000
Local Institution
Brussels, Belgium, 1070
Local Institution
Brussels, Belgium, B-1000
Brazil
Local Institution
Porto Alegre, Rio Grande Do Sul, Brazil, 90035
Local Institution
Rio De Janeiro, Brazil, 20270
Local Institution
Rio De Janeiro, Brazil, 21040
Local Institution
Sao Paulo, Brazil, 04035
Canada, Alberta
Local Institution
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
Local Institution
Vancouver, British Columbia, Canada, V6Z 2C7
Local Institution
Vancouver, British Columbia, Canada, V6Z 2K5
Local Institution
Victoria, British Columbia, Canada, V8V 3P9
Canada, Ontario
Local Institution
Ottawa, Ontario, Canada, K1H 8L6
Local Institution
Torono, Ontario, Canada, M5G 2N2
Canada, Quebec
Local Institution
Montreal, Quebec, Canada, H2L 4P9
Local Institution
Montreal, Quebec, Canada, H2L 5B1
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Montreal, Quebec, Canada, H3A 1T1
France
Local Institution
Marseille Cedex 09, France, 13274
Local Institution
Montpellier Cedex 5, France, 34295
Local Institution
Paris Cedex 10, France, 75475
Local Institution
Paris, France, 75013
Local Institution
Paris, France, 75014
Local Institution
Paris, France, 75018
Local Institution
Paris, France, 75571
Local Institution
Pessac Cedex, France, 33604
Germany
Local Institution
Berlin, Germany, 13353
Local Institution
Bonn, Germany, 53105
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Frankfurt Am Main, Germany, 60311
Local Institution
Frankfurt, Germany, 60590
Local Institution
Hamburg, Germany, 20146
Italy
Local Institution
Brescia, Italy, 25123
Local Institution
Milano, Italy, 20127
Local Institution
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
Local Institution
Nizhniy Novgorod, Russian Federation, 603005
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Saratov, Russian Federation, 410009
Local Institution
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
Spain
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
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
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
Results First Received: August 18, 2015
Last Updated: December 22, 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:
Hepatitis
Hepatitis A
Hepatitis C
Acquired Immunodeficiency Syndrome
HIV Infections
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Interferons
Ribavirin
Interferon-alpha
Peginterferon alfa-2a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors

ClinicalTrials.gov processed this record on August 25, 2016