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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 is currently recruiting participants.
Verified April 2012 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01471574
First received: November 4, 2011
Last updated: March 28, 2013
Last verified: April 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 300
Study Start Date: December 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: January 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

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

Contacts
Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

  Show 85 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trial Information  This link exits the ClinicalTrials.gov site
BMS clinical trial educational resource  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

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: March 28, 2013
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 May 23, 2013