TMC435-C212 : open label chronic Hep-C trial with HIV-1 co-infection

• Research type

  Research Study

• Full title

  A Phase III open-label study to evaluate the safety, tolerability and efficacy of TMC435 plus PegIFNa-2a (Pegasys) and ribavirin (Copegus) triple therapy in chronic hepatitis C genotype-1 infected subjects who are co-infected with human immunodeficiency virus type 1 (HIV-1).

• IRAS ID

  86443

• Contact name

  Chloe Orkin

• Sponsor organisation

  Tibotec Pharmaceuticals

• Eudract number

  2010-021337-31

• ISRCTN Number

  n/a

• Research summary

  The Hepatitis C virus (HCV) is a leading cause of liver disease worldwide. The HCV is found in approximately 30% of human immunodeficiency virus (HIV)-infected subjects. The presence of HIV has shown to speed up the time it takes the HCV to cause progression to cirrhosis and end-stage liver disease. TMC435 is a new drug in development for chronic HCV infection. In this trial it will be used in combination with the current Standard of Care (Soc) for treatment of chronic Hepatitis C infection, two drugs called pegylated interferon and ribavirin. This study will look at : the safety & how well subjects tolerate this combination of drugs; and how well TMC435 works on slowing down or stopping the growth of HCV when given with SoC therapy. About 100 subjects will enter this study. All subjects will received TMC435, pegylated interferon and ribavirin for the first 12 weeks, then subjects will receive a further 12 or 24 weeks treatment with pegylated interferon and ribavirin (depending on response to the drugs). After this there will be a 24 week follow up on the trial subjects. There is an option to participate in a DNA study which requires one additional blood sample to be taken. This is voluntary & does not effect the subjects participation in the main study. If the subject consents, this will be used to test how differences in genes alter the response subjects have to drugs.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  11/LO/1306

• Date of REC Opinion

  3 Nov 2011

• REC opinion

  Further Information Favourable Opinion