Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 or 4 HCV and HIV-1 Co-infection

PHASE3CompletedINTERVENTIONAL
Enrollment

335

Participants

Timeline

Start Date

February 28, 2014

Primary Completion Date

November 30, 2014

Study Completion Date

December 31, 2015

Conditions
Hepatitis C VirusHIV
Interventions
DRUG

LDV/SOF

90/400 mg FDC tablet administered orally once daily

DRUG

RBV

Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Trial Locations (41)

1142

Auckland

8011

Christchurch

10065

New York

10468

The Bronx

18102

Allentown

19107

Philadelphia

20815

Washington D.C.

21093

Lutherville

22003

Annandale

27599

Chapel Hill

27710

Durham

30033

Decatur

30312

Atlanta

32803

Orlando

33136

Miami

33614

Tampa

34209

Bradenton

60612

Chicago

64111

Kansas City

75235

Dallas

77004

Houston

80209

Denver

87505

Santa Fe

90027

Los Angeles

90502

Torrance

92103

San Diego

92663

Newport Beach

94110

San Francisco

95817

Sacramento

98104

Seattle

35294-2170

Birmingham

94304-5350

Palo Alto

02115

Boston

45267-0595

Cincinnati

02906

Providence

23298-0341

Richmond

V6Z 1Y6

Vancouver

K1H 8L6

Ottawa

M5G 2N2

Toronto

H2L 5B1

Montreal

00936-5607

San Juan

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY