1220.19 Phase III trial in HIV/Hepatitis patients

• Research type

  Research Study

• Full title

  Safety and Efficacy of 240 mg BI 201335 once daily in combination with pegylated interferon alpha 2a and ribavirin for treatment of chronic Hepatitis C (HCV) genotype 1 infection in HIV/HCV-co-infected patients. A multinational, randomised, parallel group, open-label trial.

• IRAS ID

  80058

• Contact name

  Mark Nelson

• Eudract number

  2010-021734-59

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This is a phase III study looking at safety and efficacy of BI 201335 in combination with pegylated interferon and ribavirin in Hepatitis C (HCV)and HIV co-infected patients. The study will be conducted in approximately 70 clinical sites in 8 countries, recruiting approximately 316 patients. The trial will include a majority of patients who have never received HCV treatment before and a smaller number who have relapsed after completion of previous HCV treatment.In combination with standard of care treatment, BI 201335 has shown a rapid, strong and maintained antiviral activity and good levels of early virological response and therefore an increased chance of a successful treatment response.

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  11/SC/0243

• Date of REC Opinion

  11 Aug 2011

• REC opinion

  Further Information Favourable Opinion