Clinical trial NCT01471574: 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
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C, Genotype 1
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2011-11-15
Enrollment: 549
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
timeFrame: Follow-up Week 12
Secondary outcomes:
measure: 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)
timeFrame: Week 1, 2, 4, 6, 8, 12 and at both Weeks 4 and 12; end of treatment; and follow-up Weeks 12 and 24
measure: Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Lower Than the Lower Limit of Quantitation (LLOQ), Target Not Detected (TND)
timeFrame: 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
measure: Percentage of Participants Who Received Highly Active Antiretroviral Therapy (HAART), Maintained HIV RNA <40 Copies/mL, and Experienced Confirmed HIV RNA ≥400 Copies/mL
timeFrame: End of treatment (up to Week 48)
measure: Percentage of Participants With Sustained Virologic Response (SVR12) by rs12979860 Single Nucleotide Polymorphism (SNP) in the IL28B Gene
timeFrame: Follow-up Week 12
measure: Number of Participants Who Died and With Serious Adverse Event (SAEs), Grade 3 to 4 Adverse Events (AEs), and AEs Leading to Discontinuation
timeFrame: From Day 1 to 7 days post last dose of study treatment (up to Week 48)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University Of Alabama At Birmingham
state: Alabama
city: La Jolla
country: United States
facility: Scripps Clinic
state: California
city: Los Angeles
country: United States
facility: Southern California Permanente Medical Group
state: California
city: Palm Springs
country: United States
facility: Desert Medical Group Inc.
state: California
city: San Diego
country: United States
facility: Ucsd Antiviral Research Center
state: California
city: San Francisco
country: United States
facility: San Francisco Gen Hosp
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente Medical Center
state: California
city: West Haven
country: United States
facility: Va Connecticut Healthcare System
state: Connecticut
city: Washington
country: United States
facility: Georgetown University Hospital
state: District of Columbia
city: Miami
country: United States
facility: University Of Miami School Of Medicine
state: Florida
city: Orlando
country: United States
facility: Orlando Immunology Center
state: Florida
city: Lutherville
country: United States
facility: Johns Hopkins University
state: Maryland
city: Newark
country: United States
facility: Saint Michael'S Medical Center
state: New Jersey
city: Bronx
country: United States
facility: James J Peters Vamc
state: New York
city: Monticello
country: United States
facility: Upper Delaware Valley Infectious Diseases, Pc
state: New York
city: New York
country: United States
facility: Icahn School Of Medicine At Mount Sinai
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Chapel Hill
country: United States
facility: University Of North Carolina At Chapel Hill
state: North Carolina
city: Charlotte
country: United States
facility: Morehead Medical Plaza
state: North Carolina
city: Dallas
country: United States
facility: Amelia Court Hiv Research Clinic
state: Texas
city: Houston
country: United States
facility: Baylor College Of Medicine
state: Texas
city: San Antonio
country: United States
facility: Texas Liver Institute
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Ciudad De Buenos Aires
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Prov De Santa Fe
country: Argentina
facility: Local Institution
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Cordoba
country: Argentina
facility: Local Institution
city: Darlinghurst Nsw
country: Australia
facility: Local Institution
state: New South Wales
city: Darlinghurst
country: Australia
facility: Local Institution
state: New South Wales
city: Clayton
country: Australia
facility: Local Institution
state: Victoria
city: Parkville
country: Australia
facility: Local Institution
state: Victoria
city: Antwerpen
country: Belgium
facility: Local Institution
city: Brussels
country: Belgium
facility: Local Institution
city: Brussels
country: Belgium
facility: Local Institution
city: Porto Alegre
country: Brazil
facility: Local Institution
state: Rio Grande Do Sul
city: Rio De Janeiro
country: Brazil
facility: Local Institution
city: Rio De Janeiro
country: Brazil
facility: Local Institution
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Edmonton
country: Canada
facility: Local Institution
state: Alberta
city: Vancouver
country: Canada
facility: Local Institution
state: British Columbia
city: Vancouver
country: Canada
facility: Local Institution
state: British Columbia
city: Victoria
country: Canada
facility: Local Institution
state: British Columbia
city: Ottawa
country: Canada
facility: Local Institution
state: Ontario
city: Torono
country: Canada
facility: Local Institution
state: Ontario
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Marseille Cedex 09
country: France
facility: Local Institution
city: Montpellier Cedex 5
country: France
facility: Local Institution
city: Paris Cedex 10
country: France
facility: Local Institution
city: Paris
country: France
facility: Local Institution
city: Paris
country: France
facility: Local Institution
city: Paris
country: France
facility: Local Institution
city: Paris
country: France
facility: Local Institution
city: Pessac Cedex
country: France
facility: Local Institution
city: Berlin
country: Germany
facility: Local Institution
city: Bonn
country: Germany
facility: Local Institution
city: Frankfurt Am Main
country: Germany
facility: Local Institution
city: Frankfurt
country: Germany
facility: Local Institution
city: Hamburg
country: Germany
facility: Local Institution
city: Brescia
country: Italy
facility: Local Institution
city: Milano
country: Italy
facility: Local Institution
city: Milano
country: Italy
facility: Local Institution
city: Modena
country: Italy
facility: Local Institution
city: Torino
country: Italy
facility: Local Institution
city: San Juan
country: Puerto Rico
facility: Fundacion De Investigacion De Diego
city: San Juan
country: Puerto Rico
facility: University Of Puerto Rico School Of Medicine
city: Kaluga
country: Russian Federation
facility: Local Institution
city: Lipetsk
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Nizhniy Novgorod
country: Russian Federation
facility: Local Institution
city: Saratov
country: Russian Federation
facility: Local Institution
city: St. Petersburg
country: Russian Federation
facility: Local Institution
city: St. Petersburg
country: Russian Federation
facility: Local Institution
city: St.petersburg
country: Russian Federation
facility: Local Institution
city: Volgograd
country: Russian Federation
facility: Local Institution
city: Badalona
country: Spain
facility: Local Institution
state: Barcelona
city: Barcelona
country: Spain
facility: Local Institution
city: Cordoba
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Sevilla
country: Spain
facility: Local Institution
city: London
country: United Kingdom
facility: Local Institution
state: Greater London
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Sulkowski MS, Fessel WJ, Lazzarin A, Berenguer J, Zakharova N, Cheinquer H, Cote P, Dieterich D, Gadano A, Matthews G, Molina JM, Moreno C, Pineda JA, Pulido F, Rivero A, Rockstroh J, Hernandez D, McPhee F, Eley T, Liu Z, Mendez P, Hughes E, Noviello S, Ackerman P. Efficacy and safety of daclatasvir plus pegylated-interferon alfa 2a and ribavirin in previously untreated HCV subjects coinfected with HIV and HCV genotype-1: a Phase III, open-label study. Hepatol Int. 2017 Mar;11(2):188-198. doi: 10.1007/s12072-017-9788-z. Epub 2017 Feb 16.