The MASH Trial
Research type
Research Study
Full title
Maraviroc Add-on Therapy for Steatohepatitis in HIV
IRAS ID
231908
Contact name
Maud Lemoine
Contact email
Sponsor organisation
Imperial College London
Eudract number
2017-003172-32
Duration of Study in the UK
1 years, 6 months, 7 days
Research summary
Non- alcoholic fatty liver disease (NAFLD) is a common liver disease defined by fat in the liver, named as “steatosis”. NAFLD is mainly caused by metabolic disorders including obesity, hypertension, high lipids or diabetes. It is most frequently a benign disease. However, steatosis can induce liver inflammation and scarring (fibrosis) defining non-alcoholic steatohepatitis (NASH). NASH is a more severe liver disease and is associated with a higher risk of liver complications including cirrhosis and liver cancer. HIV-infected patients are at particularly high risk of NAFLD (35%) and NASH (45% of biopsied patients) due to drug exposure and chronic HIV infection. In non-HIV as well as HIV individuals the diagnosis of NASH requires a liver biopsy and its best therapeutic options remain under evaluation.
Maraviroc (MVC), a licensed and well-tolerated HIV drug might also have benefits on inflammation and liver fibrosis. Experimental and human studies have shown that MVC can improve liver injuries (steatosis, inflammation and fibrosis) suggesting its potential benefits in patients with NASH. No study as examined the role of MVC in HIV- associated NASH.
The following MASH (Maraviroc add-on therapy in HIV patients with Nash) study aims to assess the benefits of MVC in addition to the current antiretroviral regimen of patients with HIV mono-infection and biopsy- confirmed NASH. Patients with liver-biopsy proven NASH will be offered 48 weeks treatment with MVC according to standard licensed dosing. They will be reviewed 2 weeks after treatment initiation and then every 3 months, before a liver biopsy at the end of treatment which will be compared to the pre-therapeutic biopsy. MVC will then be discontinued.
If the study reports significant changes in liver injury after MVC treatment, we will be able to run a larger trial. This will open the way for HIV-NASH treatment which is currently not available.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
17/EE/0387
Date of REC Opinion
30 Oct 2017
REC opinion
Further Information Favourable Opinion