search
Back to results

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

Primary Purpose

Hepatitis C, Genotype 1

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Daclatasvir
Ribavirin
PEG-Interferon alfa 2a
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C, Genotype 1

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Of Alabama At Birmingham
  • Scripps Clinic
  • Southern California Permanente Medical Group
  • Desert Medical Group Inc.
  • Ucsd Antiviral Research Center
  • San Francisco Gen Hosp
  • Kaiser Permanente Medical Center
  • Va Connecticut Healthcare System
  • Georgetown University Hospital
  • University Of Miami School Of Medicine
  • Orlando Immunology Center
  • Johns Hopkins University
  • Saint Michael'S Medical Center
  • James J Peters Vamc
  • Upper Delaware Valley Infectious Diseases, Pc
  • Icahn School Of Medicine At Mount Sinai
  • Weill Cornell Medical College
  • University Of North Carolina At Chapel Hill
  • Morehead Medical Plaza
  • Amelia Court Hiv Research Clinic
  • Baylor College Of Medicine
  • Texas Liver Institute
  • Virginia Commonwealth University
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Fundacion De Investigacion De Diego
  • University Of Puerto Rico School Of Medicine
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Daclatsvir + Ribavirin + PEG-Interferon alfa-2a

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
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)
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)
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
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
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
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.

Full Information

First Posted
November 4, 2011
Last Updated
December 22, 2015
Sponsor
Bristol-Myers Squibb
search

1. Study Identification

Unique Protocol Identification Number
NCT01471574
Brief Title
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

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Genotype 1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
549 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Daclatsvir + Ribavirin + PEG-Interferon alfa-2a
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Daclatasvir
Other Intervention Name(s)
BMS-790052
Intervention Description
Tablets; oral; 30, 60, or 90 mg; once daily; up to 24 weeks
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Other Intervention Name(s)
Copegus®
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
PEG-Interferon alfa 2a
Other Intervention Name(s)
Pegasys®, Pegylated interferon
Intervention Description
Syringe, subcutaneous injection, 180 μg, once weekly, 24 or 48 weeks depending on response
Primary Outcome Measure Information:
Title
Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
Description
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.
Time Frame
Follow-up Week 12
Secondary Outcome Measure Information:
Title
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)
Description
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.
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
Title
Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Lower Than the Lower Limit of Quantitation (LLOQ), Target Not Detected (TND)
Description
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.
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
Title
Percentage of Participants Who Received Highly Active Antiretroviral Therapy (HAART), Maintained HIV RNA <40 Copies/mL, and Experienced Confirmed HIV RNA ≥400 Copies/mL
Description
Participants who received HAART, maintained HIV RNA <40 copies/mL, and experienced confirmed HIV RNA ≥ 400 copies/mL were determined.
Time Frame
End of treatment (up to Week 48)
Title
Percentage of Participants With Sustained Virologic Response (SVR12) by rs12979860 Single Nucleotide Polymorphism (SNP) in the IL28B Gene
Description
Percentages calculated as number of responders/number who received treatment.
Time Frame
Follow-up Week 12
Title
Number of Participants Who Died and With Serious Adverse Event (SAEs), Grade 3 to 4 Adverse Events (AEs), and AEs Leading to Discontinuation
Description
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.
Time Frame
From Day 1 to 7 days post last dose of study treatment (up to Week 48)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
University Of Alabama At Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Scripps Clinic
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Southern California Permanente Medical Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Desert Medical Group Inc.
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
Ucsd Antiviral Research Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
San Francisco Gen Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Kaiser Permanente Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Facility Name
Va Connecticut Healthcare System
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States
Facility Name
Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
University Of Miami School Of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Orlando Immunology Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Johns Hopkins University
City
Lutherville
State/Province
Maryland
ZIP/Postal Code
21093
Country
United States
Facility Name
Saint Michael'S Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07102
Country
United States
Facility Name
James J Peters Vamc
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States
Facility Name
Upper Delaware Valley Infectious Diseases, Pc
City
Monticello
State/Province
New York
ZIP/Postal Code
12701
Country
United States
Facility Name
Icahn School Of Medicine At Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
University Of North Carolina At Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Morehead Medical Plaza
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Amelia Court Hiv Research Clinic
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Baylor College Of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Liver Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Local Institution
City
Ciudad De Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1121ABE
Country
Argentina
Facility Name
Local Institution
City
Prov De Santa Fe
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Local Institution
City
Buenos Aires
ZIP/Postal Code
1181
Country
Argentina
Facility Name
Local Institution
City
Buenos Aires
ZIP/Postal Code
C1181
Country
Argentina
Facility Name
Local Institution
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
Local Institution
City
Darlinghurst Nsw
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Local Institution
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Local Institution
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Local Institution
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Local Institution
City
Antwerpen
ZIP/Postal Code
2000
Country
Belgium
Facility Name
Local Institution
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Local Institution
City
Brussels
ZIP/Postal Code
B-1000
Country
Belgium
Facility Name
Local Institution
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035
Country
Brazil
Facility Name
Local Institution
City
Rio De Janeiro
ZIP/Postal Code
20270
Country
Brazil
Facility Name
Local Institution
City
Rio De Janeiro
ZIP/Postal Code
21040
Country
Brazil
Facility Name
Local Institution
City
Sao Paulo
ZIP/Postal Code
04035
Country
Brazil
Facility Name
Local Institution
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Local Institution
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2C7
Country
Canada
Facility Name
Local Institution
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2K5
Country
Canada
Facility Name
Local Institution
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8V 3P9
Country
Canada
Facility Name
Local Institution
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Local Institution
City
Torono
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada
Facility Name
Local Institution
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4P9
Country
Canada
Facility Name
Local Institution
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 5B1
Country
Canada
Facility Name
Local Institution
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1T1
Country
Canada
Facility Name
Local Institution
City
Marseille Cedex 09
ZIP/Postal Code
13274
Country
France
Facility Name
Local Institution
City
Montpellier Cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
Local Institution
City
Paris Cedex 10
ZIP/Postal Code
75475
Country
France
Facility Name
Local Institution
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Local Institution
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Local Institution
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Local Institution
City
Paris
ZIP/Postal Code
75571
Country
France
Facility Name
Local Institution
City
Pessac Cedex
ZIP/Postal Code
33604
Country
France
Facility Name
Local Institution
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Local Institution
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Local Institution
City
Frankfurt Am Main
ZIP/Postal Code
60311
Country
Germany
Facility Name
Local Institution
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Local Institution
City
Hamburg
ZIP/Postal Code
20146
Country
Germany
Facility Name
Local Institution
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Local Institution
City
Milano
ZIP/Postal Code
20127
Country
Italy
Facility Name
Local Institution
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Local Institution
City
Modena
ZIP/Postal Code
41100
Country
Italy
Facility Name
Local Institution
City
Torino
ZIP/Postal Code
10149
Country
Italy
Facility Name
Fundacion De Investigacion De Diego
City
San Juan
ZIP/Postal Code
00927
Country
Puerto Rico
Facility Name
University Of Puerto Rico School Of Medicine
City
San Juan
ZIP/Postal Code
00935
Country
Puerto Rico
Facility Name
Local Institution
City
Kaluga
ZIP/Postal Code
248023
Country
Russian Federation
Facility Name
Local Institution
City
Lipetsk
ZIP/Postal Code
398043
Country
Russian Federation
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
111123
Country
Russian Federation
Facility Name
Local Institution
City
Nizhniy Novgorod
ZIP/Postal Code
603005
Country
Russian Federation
Facility Name
Local Institution
City
Saratov
ZIP/Postal Code
410009
Country
Russian Federation
Facility Name
Local Institution
City
St. Petersburg
ZIP/Postal Code
191167
Country
Russian Federation
Facility Name
Local Institution
City
St. Petersburg
ZIP/Postal Code
196645
Country
Russian Federation
Facility Name
Local Institution
City
St.petersburg
ZIP/Postal Code
190103
Country
Russian Federation
Facility Name
Local Institution
City
Volgograd
ZIP/Postal Code
400040
Country
Russian Federation
Facility Name
Local Institution
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Local Institution
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Local Institution
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Local Institution
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Local Institution
City
London
State/Province
Greater London
ZIP/Postal Code
SW10 9NH
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
28210927
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.
Results Reference
derived
Links:
URL
http://www.bms.com/studyconnect/Pages/home.aspx
Description
BMS clinical trial educational resource

Learn more about this trial

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

We'll reach out to this number within 24 hrs