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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.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01471574
First received: November 4, 2011
Last updated: November 20, 2014
Last verified: July 2014

November 4, 2011
November 20, 2014
December 2011
June 2014   (final data collection date for primary outcome measure)
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
Proportion of subjects with SVR12, defined as HCV RNA < LOQ (detectable or undetectable) [ 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
  • LOQ = Limit of quantitation
Complete list of historical versions of study NCT01471574 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Proportion of subjects with Genotype 1 infection who achieve HCV RNA < LOQ (detectable or undetectable) [ 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 undetectable [ 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 ]
Not Provided
Not Provided
 
Safety and Efficacy Study of BMS-790052 Plus Peg-Interferon Alfa 2a and Ribavirin in Untreated Hepatitis C Patients Coinfected With HIV Virus
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)

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

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis C, Genotype 1
  • 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®
Experimental: BMS-790052 (Daclatasvir) + Ribavirin + Peg-Interferon alfa-2a
Interventions:
  • Drug: BMS-790052 (Daclatasvir)
  • Drug: Ribavirin
  • Drug: Peg-Interferon alfa 2a
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
301
September 2014
June 2014   (final data collection date for primary outcome measure)

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)
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Belgium,   Brazil,   Canada,   France,   Germany,   Italy,   Puerto Rico,   Russian Federation,   Spain,   United Kingdom
 
NCT01471574
AI444-043, 2011-003067-30
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP