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Clinical Trials

MainTitle

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
Bristol-Myers Squibb


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
History of Changes
Purpose

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: Intervention Model: Single Group Assignment
Masking: None (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)

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 ]
    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 ]
    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 ]
    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) ]
    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 ]
    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) ]
    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 Name:
  • Pegasys®
  • Pegylated interferon

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 70 Years  
Sexes Eligible for Study: All  
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

    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

    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
    Local Institution
    Darlinghurst Nsw, New South Wales, Australia, 2010
    Local Institution
    Darlinghurst, New South Wales, Australia, 2010
    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
    Local Institution
    Edmonton, Alberta, Canada, T6G 2B7
    Local Institution
    Vancouver, British Columbia, Canada, V6Z 2C7
    Local Institution
    Vancouver, British Columbia, Canada, V6Z 2K5
    Local Institution
    Victoria, British Columbia, Canada, V8V 3P9
    Local Institution
    Ottawa, Ontario, Canada, K1H 8L6
    Local Institution
    Torono, Ontario, Canada, M5G 2N2
    Local Institution
    Montreal, Quebec, Canada, H2L 4P9
    Local Institution
    Montreal, Quebec, Canada, H2L 5B1
    Local Institution
    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
    Local Institution
    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
    Local Institution
    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

    More Information

    Additional Information:

    BMS Clinical Trial Information

    Additional Information:

    BMS clinical trial educational resource

    Additional Information:

    Investigator Inquiry form

    Additional Information:

    FDA Safety Alerts and Recalls

    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: December 22, 2015  

    Additional relevant MeSH terms:
    Hepatitis
    Hepatitis A
    Hepatitis C
    Interferons
    Ribavirin
    Interferon-alpha
    Peginterferon alfa-2a

    ClinicalTrials.gov processed this data on October 20, 2017
    This information is provided by ClinicalTrials.gov.