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
- Conditions
- Hepatitis C, Genotype 1
- Interventions
- Registration Number
- NCT01471574
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 549
- 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
-
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:
- Neutrophil count <1500 cells/μL (<1200 cells/ μL for Blacks)
- Platelet count <90,000 cells/μL
- Hemoglobin ≤12 g/dL for females, hemoglobin ≤13 g/dL for males
- 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
- Alanine aminotransferase ≥5*upper limit of normal
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Daclatsvir + Ribavirin + PEG-Interferon alfa-2a Ribavirin - Daclatsvir + Ribavirin + PEG-Interferon alfa-2a PEG-Interferon alfa 2a - Daclatsvir + Ribavirin + PEG-Interferon alfa-2a Daclatasvir -
- Primary Outcome Measures
Name Time Method Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) 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
Name Time Method 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) 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) 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 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 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 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.
Trial Locations
- Locations (26)
Georgetown University Hospital
🇺🇸Washington, District of Columbia, United States
Icahn School Of Medicine At Mount Sinai
🇺🇸New York, New York, United States
San Francisco Gen Hosp
🇺🇸San Francisco, California, United States
University Of Miami School Of Medicine
🇺🇸Miami, Florida, United States
Texas Liver Institute
🇺🇸San Antonio, Texas, United States
University Of Alabama At Birmingham
🇺🇸Birmingham, Alabama, United States
Scripps Clinic
🇺🇸La Jolla, California, United States
Southern California Permanente Medical Group
🇺🇸Los Angeles, California, United States
Desert Medical Group Inc.
🇺🇸Palm Springs, California, United States
Ucsd Antiviral Research Center
🇺🇸San Diego, California, United States
Kaiser Permanente Medical Center
🇺🇸San Francisco, California, United States
Orlando Immunology Center
🇺🇸Orlando, Florida, United States
Va Connecticut Healthcare System
🇺🇸West Haven, Connecticut, United States
Saint Michael'S Medical Center
🇺🇸Newark, New Jersey, United States
James J Peters Vamc
🇺🇸Bronx, New York, United States
Johns Hopkins University
🇺🇸Lutherville, Maryland, United States
Upper Delaware Valley Infectious Diseases, Pc
🇺🇸Monticello, New York, United States
Weill Cornell Medical College
🇺🇸New York, New York, United States
Morehead Medical Plaza
🇺🇸Charlotte, North Carolina, United States
University Of North Carolina At Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Baylor College Of Medicine
🇺🇸Houston, Texas, United States
Amelia Court Hiv Research Clinic
🇺🇸Dallas, Texas, United States
Local Institution
🇬🇧London, Greater London, United Kingdom
Fundacion De Investigacion De Diego
🇵🇷San Juan, Puerto Rico
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
University Of Puerto Rico School Of Medicine
🇵🇷San Juan, Puerto Rico