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?
Coronavirus (COVID-19) Guidance
Trial Treatment and Follow-up Assessments
MRI scans and face-to-face follow-up visits are suspended as they are not essential activities at this time. We are asking that if you are due to have MAVMET follow-ups with participants, that these are done by phone, where possible. We understand that not all the data can be collected in this way. The priority is to check that the participant is ok and whether they have experienced any AEs/SAEs. Form 12 has been updated so that you can mark that the data was collected over the phone so that we don’t chase you for missing data.
It is important that participants remain on their antiretroviral medication. Please ensure they have enough.
We are currently investigating the possibility of obtaining enough IMP to allow participants to remain on trial drug until later in the year when it is possible to have an MRI scan. If this is possible, we will ask you to postpone the week 48 visit (if participants are willing) until the scans can take place.
Contact with the Unit Team / Returning Data
The CTU team are now all working remotely but can still be contacted on the normal numbers and via the trial mailbox.
Please continue to send CRFs via Galaxkey to firstname.lastname@example.org.
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 have been 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?
6 sites in the UK:
Mortimer Market Centre, London
Guy’s and St.Thomas’ Hospital, London
King’s College Hospital, London
Recruitment closed on 21st October and 90 participants were 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.