M14-004 AbbVie DAA's +Ribavirin in HCV Gt1 or 4/HIV Type 1 Coinfection
Research type
Research Study
Full title
M14-004 A Multipart, Open-label Study to Evaluate the Safety and Efficacy of Ombitasvir (ABT450)/Paritaprevir (ABT267)/Ritonavir With and Without Dasabuvir (ABT 333) Coadministered With and Without Ribavirin in Adults With Genotype 1 or 4 Chronic Hepatitis C Virus Infection and Human Immunodeficiency Virus, Type 1 Coinfection (TURQUOISE-I)
IRAS ID
153501
Contact name
Daniel Kreeb
Contact email
Sponsor organisation
Abbvie GmbH & Co. KG
Eudract number
2012-005143-24
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 4 months, 25 days
Research summary
Of the 33.4 million people infected with HIV in 2009, it is estimated that 5 million of these people are also infected with Hepatitis C. While there are standard treatments available for patients with HIV, patients who have both HIV and Hepatitis C are faced with a bigger chance of developing progressive liver disease and death.
This study will assess the safety and effectiveness of the three drugs (ombitasvir, paritaprevir and dasabuvir) in patients with Hepatitis C and HIV. Ombitasvir, paritaprevir and dasabuvir are drugs called ‘Direct-Acting Antiviral Agents’ (DAAs) and will be given along with another drug called ritonavir, which is used to slow down the rate at which paritaprevir is broken down by the body. A drug called ribavirin (RBV) may also be used for Hepatitis C. Ombitasvir, paritaprevir (with ritonavir) and dasabuvir with and without RBV have already been shown to be effective in clearing Hepatitis C virus from people without HIV who have taken them.
The standard treatments available for patients who have both HIV and Hepatitis C can cause significant side effects.
There are different types of Hepatitis C and patients with genotypes 1 and 4 will be allowed on the study. Genotype 1 patients will receive all 3 DAAs whereas genotype 4 patients will receive just 2 DAAs (ombitasvir and paritaprevir). The study will be conducted in hospital clinics in the UK.
Once enrolled, subjects will attend regular study visits at hospital clinics over a 36-48 week period. Subjects will take the DAAs for either 12 or 24 weeks. The effect of the treatments on the virus will be checked by performing blood tests and collecting general medical health information.
REC name
London - London Bridge Research Ethics Committee
REC reference
15/LO/1063
Date of REC Opinion
28 Jul 2015
REC opinion
Further Information Favourable Opinion