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

PHASE3CompletedINTERVENTIONAL
Enrollment

549

Participants

Timeline

Start Date

December 31, 2011

Primary Completion Date

June 30, 2014

Study Completion Date

September 30, 2014

Conditions
Hepatitis C, Genotype 1
Interventions
DRUG

Daclatasvir

Tablets; oral; 30, 60, or 90 mg; once daily; up to 24 weeks

DRUG

Ribavirin

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

DRUG

PEG-Interferon alfa 2a

Syringe, subcutaneous injection, 180 μg, once weekly, 24 or 48 weeks depending on response

Trial Locations (86)

1070

Local Institution, Brussels

1181

Local Institution, Buenos Aires

2000

Local Institution, Prov de Santa Fe

Local Institution, Antwerp

2010

Local Institution, Darlinghurst

Local Institution, Darlinghurst Nsw

3050

Local Institution, Parkville

3168

Local Institution, Clayton

5000

Local Institution, Córdoba

10029

Icahn School Of Medicine At Mount Sinai, New York

10065

Weill Cornell Medical College, New York

10149

Local Institution, Torino

10468

James J Peters Vamc, The Bronx

12701

Upper Delaware Valley Infectious Diseases, Pc, Monticello

13274

Local Institution, Marseille

13353

Local Institution, Berlin

14004

Local Institution, Córdoba

20007

Georgetown University Hospital, Washington D.C.

20127

Local Institution, Milan

20146

Local Institution, Hamburg

20162

Local Institution, Milan

20270

Local Institution, Rio de Janeiro

21040

Local Institution, Rio de Janeiro

21093

Johns Hopkins University, Lutherville

23298

Virginia Commonwealth University, Richmond

25123

Local Institution, Brescia

27599

University Of North Carolina At Chapel Hill, Chapel Hill

28007

Local Institution, Madrid

28040

Local Institution, Madrid

28041

Local Institution, Madrid

28046

Local Institution, Madrid

28204

Morehead Medical Plaza, Charlotte

32803

Orlando Immunology Center, Orlando

33136

University Of Miami School Of Medicine, Miami

33604

Local Institution, Pessac

34295

Local Institution, Montpellier

35294

University Of Alabama At Birmingham, Birmingham

41014

Local Institution, Seville

41100

Local Institution, Modena

53105

Local Institution, Bonn

60311

Local Institution, Frankfurt am Main

60590

Local Institution, Frankfurt

75013

Local Institution, Paris

75014

Local Institution, Paris

75018

Local Institution, Paris

75235

Amelia Court Hiv Research Clinic, Dallas

75475

Local Institution, Paris

75571

Local Institution, Paris

77030

Baylor College Of Medicine, Houston

78215

Texas Liver Institute, San Antonio

90027

Southern California Permanente Medical Group, Los Angeles

90035

Local Institution, Porto Alegre

92037

Scripps Clinic, La Jolla

92103

Ucsd Antiviral Research Center, San Diego

92262

Desert Medical Group Inc., Palm Springs

94110

San Francisco Gen Hosp, San Francisco

94118

Kaiser Permanente Medical Center, San Francisco

111123

Local Institution, Moscow

190103

Local Institution, Saint Petersburg

191167

Local Institution, Saint Petersburg

196645

Local Institution, Saint Petersburg

248023

Local Institution, Kaluga

398043

Local Institution, Lipetsk

400040

Local Institution, Volgograd

410009

Local Institution, Saratov

603005

Local Institution, Nizhny Novgorod

06516

Va Connecticut Healthcare System, West Haven

07102

Saint Michael'S Medical Center, Newark

C1181

Local Institution, Buenos Aires

C1121ABE

Local Institution, Ciudad de Buenos Aires

B-1000

Local Institution, Brussels

04035

Local Institution, São Paulo

T6G 2B7

Local Institution, Edmonton

V6Z 2C7

Local Institution, Vancouver

V6Z 2K5

Local Institution, Vancouver

V8V 3P9

Local Institution, Victoria

K1H 8L6

Local Institution, Ottawa

M5G 2N2

Local Institution, Torono

H2L 4P9

Local Institution, Montreal

H2L 5B1

Local Institution, Montreal

H3A 1T1

Local Institution, Montreal

00927

Fundacion De Investigacion De Diego, San Juan

00935

University Of Puerto Rico School Of Medicine, San Juan

08916

Local Institution, Badalona

08003

Local Institution, Barcelona

SW10 9NH

Local Institution, London

Sponsors
All Listed Sponsors
lead

Bristol-Myers Squibb

INDUSTRY