NCT01783678View on ClinicalTrials.gov

A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2, 3 and 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Adults

PHASE3CompletedINTERVENTIONAL
Enrollment

275

Participants

Timeline

Start Date

January 31, 2013

Primary Completion Date

April 30, 2014

Study Completion Date

July 31, 2014

Conditions
Chronic Hepatitis CHuman Immunodeficiency Virus
Interventions
DRUG

Sofosbuvir

Sofosbuvir 400 mg tablet administered orally once daily

DRUG

RBV

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

Trial Locations (24)

Unknown

Darlinghurst

Sydney

Melbourne

Parkville

Lyon

Nice

Paris

Berlin

Bonn

Düsseldorf

Frankfurt

Hamburg

Würzburg

Bergamo

Milan

Napoli

Rome

Torino

Barcelona

Madrid

Seville

Glasgow

London

Sussex

Sponsors

Lead Sponsor

Gilead Sciences
All Listed Sponsors
lead

Gilead Sciences

INDUSTRY

NCT01783678 - A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2, 3 and 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Adults | Biotech Hunter | Biotech Hunter