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
Fatty liver disease associated with overweight/obesity, can cause liver inflammation, which can lead to scarring of the liver (cirrhosis), liver cancer and early death. It is predicted that fatty liver disease will become the number one cause of liver cirrhosis in the next 20 years. There are no effective treatments, except weight loss, which is rarely successful.
In HIV-infected individuals, antiretroviral therapy (ART) is successful at maintaining health long-term, however data suggest that HIV-infected individuals are at increased risk of developing fatty liver disease, even if they are not overweight. Past exposure to some ART drugs, may have added to this risk.
MAVMET is trying to find out if maraviroc (a licensed anti-HIV drug) and metformin (licensed for diabetes), given separately or in combination will reduce the amount of liver fat.
MAVMET participants are HIV-infected adults, aged at least 35, with HIV (but not hepatitis B/C) for 5 years or more, on combination ART for at least 1 year, and likely - because of abnormal liver tests and/or a large waist to have increased liver fat, or already have a confirmed diagnosis of fatty liver disease, on a previous scan or a liver biopsy.
Participants will continue on their current ART and be randomised to receive 48 weeks of maraviroc (Arm A) or metformin (Arm B) or both drugs (Arm C) or no additional drugs (Arm D). Participants will be followed up for 48 weeks.
Links to other research
Other research from the UCL Centre for Clinical Research in Infection and Sexual Health
Other research from IGH in the UK