Provided by NATAP
This study is currently recruiting participants.
Verified February 2012 by Tibotec Pharmaceuticals, Ireland
Estimated Enrollment: 100
150 mg capsule once daily for 12 weeks in addition to peginterferon alfa-2a and ribavirin for 24 or 48 weeks
First Received on October 18, 2011. Last Updated on February 27, 2012
This is an open-label (all people know the identity of the intervention) study of TMC435 in patients who are infected with genotype 1 hepatitis C virus and co-infected with human immunodeficiency virus (HIV). Patients in this study will also receive two other drugs for their hepatitis C infection called peginterferon alfa-2a and ribavirin. The purpose of the study is to investigate the safety, tolerability, and efficacy of TMC435 against hepatitis C virus in this patient population. For the first 12 weeks all patients will receive TMC435 plus peginterferon alfa-2a and ribavirin. For the subsequent 12 weeks, patients will take peginterferon alfa-2a and ribavirin only. After that, based on prior HCV treatment experience and prespecified on-treatment response criteria, some patients will continue to take peginterferon alfa-2a and ribavirin for total treatment duration of 48 weeks. The study doctor will inform each patient about how to take their study medication and when they should stop taking it. Patients will take their own regimen of HIV medication(s) throughout the study, according to the instructions of the study doctor. After a patient stops taking study medication, they will continue to come to the study doctor's office for study visits for up to 72 weeks after they received the first dose of treatment in the study. The maximum duration of the study is 81 weeks (including screening). Patients will be monitored for safety throughout the study. Study assessments at each study visit may include, but are not limited to: blood and urine collection for testing and physical examinations.