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

Completed · Phase 3

Conditions studied: Hepatitis C Virus Genotype-1

In brief

The purpose of this study is to evaluate the safety and tolerability of TMC435 along with pegylated interferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) triple therapy in hepatitis C virus genotype-1 infected subjects, co-infected with human immunodeficiency virus-type 1, and to evaluate the number of patients with sustained virologic response (SVR) at 12 weeks after the planned end of treatment.

Key facts

Study ID

NCT01479868

Run by

Janssen R&D Ireland

People needed

109

Starts

2011-10-01

Expected to finish

2013-08-01

Last updated by the study team

2014-10-29

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A liver biopsy required within 3 years prior to screening unless the patient has a contraindication for a liver biopsy
• Patients with bridging fibrosis or cirrhosis and without a liver biopsy result within 2 years prior screening must have an ultrasound taken within 2 months prior to the screening visit or during screening with no findings suspicious for hepatocellular carcinoma (HCC)
• Genotype-1 hepatitis C virus (HCV) infection
• Plasma HCV ribonucleic acid (RNA) of more than 10,000 IU per mL
• Documented human immunodeficiency virus-type 1 (HIV-1) infection at least 6 months prior to screening

You may not qualify if…

• Patient showing evidence of hepatic decompensation (ie, history or current evidence of ascites, bleeding varices or hepatic encephalopathy, albumin serum concentration less than 3.3 gm per dL, prolonged prothrombin time [PT] expressed as international normalized ratio [INR] more than 1.5)
• Any liver disease of non-HCV etiology
• Co-infection with hepatitis B virus (hepatitis B surface antigen [HBsAg] positive)
• An acute HIV-1 infection; or HIV-2 infection
• Change in antiretroviral (ARV) regimen within the last 4 weeks prior screening

Where it is running

• Study site — Los Angeles, California, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Orlando, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Newark, New Jersey, United States
• Study site — Albany, New York, United States
• Study site — New York, New York, United States
• Study site — Dallas, Texas, United States
• Study site — Houston, Texas, United States
• Study site — Toronto, Ontario, Canada
• Study site — Montreal, Quebec, Canada
• Study site — Lyon, France
• Study site — Montpellier, France
• Study site — Nantes, France
• Study site — Paris, France
• Study site — Berlin, Germany
• Study site — Bonn, Germany
• Study site — Cologne, Germany
• Study site — Düsseldorf, Germany
• Study site — Frankfurt, Germany
• Study site — Freiburg im Breisgau, Germany
• Study site — Hamburg, Germany
• Study site — Amadora, Portugal
• Study site — Lisbon, Portugal

Full record on ClinicalTrials.gov

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