VX-950HPC3008 (INSIGHT)
Research type
Research Study
Full title
Open-Label, Phase 3b Study to Determine Efficacy and Safety of Telaprevir, Pegylated-Interferon-alfa-2a and Ribavirin in Hepatitis C Virus Treatment-Naïve and Treatment-Experienced Subjects with Genotype 1 Chronic Hepatitis C and Human Immunodeficiency Virus Type 1 (HCV-1/HIV-1) Coinfection
IRAS ID
96887
Contact name
Mark Nelson
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2011-004928-35
Clinicaltrials.gov Identifier
Research summary
In this study Telaprevir is being studied in patients who have been diagnosed with both chronic HCV1 (genotype1) and HIV1 infections.Telaprevir is approved for the treatment of chronic hepatitis C in the United States, Canada, Switzerland and the European Union when used together with pegylated interferon alfa2a (PegIFNalfa2a/ Pegylated interferon) and ribavirin. Pegylated interferon and ribavirin is a combined therapy already approved to treat chronic HCV as standard care. Telaprevir, given together with the current standard of care treatment (Pegylated interferon and ribavirin) is being studied for the treatment of hepatitis C in patients coinfected both with HCV1 and HIV1.About 150 patients are expected to participate in 8 countries over a period of 76 weeks. The main aim of this research is to assess how well treatment with telaprevir, PegIFNalfa2a, and ribavirin work in clearing the virus from the body and the safety of treatment in patients who are with both chronic HCV1 and HIV1.This study will include patients who have not had treatment for their hepatitis C and patients who have already been treated with standard care. The study will consist of 3 phases: a screening phase, an open-label treatment phase up to 48 weeks, and a follow-up period of 24 weeks. All patients will receive 12 weeks of treatment with telaprevir given with Peg-IFN-alfa-2a and RBV. At week 12 telaprevir dosing will end and patients will continue on Peg-IFN-alfa-2a and RBV. The total treatment duration in this study will be 24 or 48 weeks depending on the patient's prior HCV treatment status, liver disease status, and individual on-treatment virologic response in this study (= response guided therapy). The maximum total duration of participation in the study for an individual participant will be approximately 76 weeks (screening included).
REC name
London - Fulham Research Ethics Committee
REC reference
12/LO/0268
Date of REC Opinion
25 Apr 2012
REC opinion
Further Information Favourable Opinion