NCT01479868View on ClinicalTrials.gov

A Study to Assess the Safety, Tolerability and Efficacy of TMC435 Along With Pegylated Interferon Alpha-2a (Pegasys) and Ribavirin (Copegus) Triple Therapy in Chronic Hepatitis C Genotype-1 Infected Patients Co-infected With Human Immunodeficiency Virus-Type 1

PHASE3CompletedINTERVENTIONAL
Enrollment

109

Participants

Timeline

Start Date

October 31, 2011

Primary Completion Date

August 31, 2013

Study Completion Date

August 31, 2013

Conditions
Hepatitis C Virus Genotype-1
Interventions
DRUG

TMC435

TMC435 150 mg will be administered once daily for 12 weeks along with peginterferon alpha-2a and ribavirin.

DRUG

Pegylated interferon alpha-2a

Pegylated interferon alpha-2a 180 microgram will be administered as subcutaneous injection of 0.5 mL until 24 to 48 weeks.

DRUG

Ribavirin

Ribavirin 1000 or 1200 mg twice daily will be administered each day until 24 to 48 weeks.

Trial Locations (32)

Unknown

Los Angeles

Washington D.C.

Orlando

Atlanta

Chicago

Newark

Albany

New York

Dallas

Houston

Toronto

Montreal

Lyon

Montpellier

Nantes

Paris

Berlin

Bonn

Cologne

Düsseldorf

Frankfurt

Freiburg im Breisgau

Hamburg

Amadora

Lisbon

Porto

San Juan

Badalona

Elche

Madrid

Brighton

London

All Listed Sponsors
lead

Janssen R&D Ireland

INDUSTRY

NCT01479868 - A Study to Assess the Safety, Tolerability and Efficacy of TMC435 Along With Pegylated Interferon Alpha-2a (Pegasys) and Ribavirin (Copegus) Triple Therapy in Chronic Hepatitis C Genotype-1 Infected Patients Co-infected With Human Immunodeficiency Virus-Type 1 | Biotech Hunter | Biotech Hunter