VX-950HPC3005: Telaprevir Open-Label Study in Co-Infected Patients
Research type
Research Study
Full title
Multicenter, Open-Label Study of Telaprevir in Combination With Peginterferon Alfa and Ribavirin in Human Immunodeficiency Virus/Genotype 1 Chronic Hepatitis C Coinfected Subjects With Severe Fibrosis or Compensated Cirrhosis
IRAS ID
102032
Contact name
Mark Nelson
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2011-003593-85
Clinicaltrials.gov Identifier
Research summary
In this study Telaprevir is being studied in patients who have been diagnosed with both chronic Hepatitis C (genotype 1) and HIV infections with severe liver fibrosis (formation of excess fibrous connective tissue) or compensated liver disease. 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 and ribavarin. Pegylated interferon and ribavarin is a combined therapy already approved to treat chronic Hepatitis C as standard care. Telaprevir, given together with the current standard of care treatment (pegylated interferon and ribavarin) is being studied for the treatment of hepatitis C in patients coinfected with both Hepatitis C (genotype 1) and HIV. The aim of the Telaprevir treatment is to eradicate the Hepatitis C virus out of the patient's body. About 1000 patients are expected to participate in 11 countries. The main aim of this research is to collect additional safety and tolerability information on treatment with Telaprevir in combination with pegylated interferon alfa and ribavarin. This study will include male and female patients, aged 18-70 years inclusive, who have not had treatment for their Hepatitis C, as well as patients who have already been treated with standard care. The study will consist of 3 phases: screening phase, an open-label treatment phase of 48 weeks and a post treatment follow up visit 24 weeks after the last dose of treatment. All patients will receive 12 weeks of treatment with Telaprevir given with pegylated interferon alfa and ribavirin. At week 12 Teleprevir dosing will end and patients will continue on pegylated interferon alfa and ribavirin for a further 36 weeks. The patient will then return 24 weeks later for a follow-up visit (week 72). The maximum total duration of participation in the study for the participant will be approximately 78 weeks (6 week screening period included).
REC name
London - Bloomsbury Research Ethics Committee
REC reference
12/LO/0497
Date of REC Opinion
30 May 2012
REC opinion
Further Information Favourable Opinion