A multicentre, 48 week randomised controlled factorial trial of adding maraviroc and/or metformin for hepatic steatosis in HIV-1-infected adults on combination antiretroviral therapy.
Can either of the drugs maraviroc or metformin, or a combination of the two, reduce fatty liver disease among people living with HIV?
What is this study about?
Fatty liver disease refers to the build-up of fat in the liver cells. It can be caused by excessive alcohol intake, but it can also happen in people who drink little or no alcohol. Although having fat in the liver does not cause damage itself, it can cause inflammation, which damages the liver, scarring it and reducing its ability to function, known as cirrhosis. If the liver is significantly damaged it will eventually need to be removed, and replaced with a transplant liver.
Fatty liver disease not caused by alcohol is a common finding in HIV-infected patients, and can lead to serious problems.
The MAVMET trial is trying to find ways to reduce the amount of fat in the liver. It is testing whether maraviroc, a licensed treatment for HIV infection, and metformin, a licensed treatment for diabetes, are effective and safe at reducing the amount of fat in the liver. The percentage of fat in the liver is measured using a non-invasive scan, the MRI fat-fraction scan.
Patients will be randomly split into four groups, of roughly equal size. Each group will receive a different treatment. All patients receive treatment for 48 weeks:
Group A: maraviroc tablets twice a day (the dose received dependent upon the individual patient’s standard HIV treatment).
Group B: metformin 500mg (tablets twice a day)
Group C: maraviroc tablets twice a day (the dose received dependent upon the individual patient’s standard HIV treatment) PLUS metformin 500mg (tablets twice a day).
Group D: no additional therapy.
Type of study
Who is funding the study?
Investigator initiated grant from ViiV Healthcare UK.
When is it taking place?
October 2017 - April 2021
Where is it taking place?
3 sites in the UK:
Mortimer Market Centre, London
Guy’s and St.Thomas’ Hospital, London
King’s College Hospital, London
As of 1st June 2018, 15 participants have been recruited to the trial
Who is included?
HIV-1-infected adults, 35 or older, with liver disease not caused by excess alcohol intake.
Participants must have been HIV positive for at least 5 years and be stable on standard treatment for at least 1 year.
Participants must not have a hepatitis B or C infection.
Participants must have fatty liver disease already (confirmed on a prior scan or tissue sample), or suspected fatty liver disease (a large waist* and/or abnormal liver markers in the blood* with no other cause for these abnormalities).
*Rationale: Fatty liver disease is more likely if people have high levels of some liver enzymes (markers of inflammation in the liver), and/or if they have a large amounts of fat around the waist, which is strongly linked to fatty liver disease.