A phase IV, open-label, pilot study investigating non-invasive markers of hepatic fibrosis in people living with HIV-1 and non-alcoholic fatty liver disease randomised to receiving optimised background therapy (OBT) plus maraviroc or OBT
Trial acronym: HEPMARC
Description
Non-alcoholic fatty liver disease (NAFLD) is a very common medical condition in which fat is retained in the liver. It is linked to obesity, and diabetes, amongst other conditions. It’s also more common in people living with HIV, with around 30% of people with HIV having NAFLD. It is important because, in some of these cases it can lead to the liver becoming damaged by cells of the immune system (called inflammation). This in turn can cause scarring of the liver (called fibrosis), which can eventually become irreversible (called cirrhosis). Cirrhosis can cause serious illnesses including liver cancer.
We need to find ways of treating NAFLD and stopping it from turning into more serious liver disease. The drug maraviroc has been used to treat HIV itself for many years. Maraviroc works by binding onto a CCR5 receptor on the surface of cells, blocking HIV virus from getting into the cell. We also know that CCR5 is important in the pathway by which inflammation takes place. Blocking CCR5 receptors with maraviroc may therefore reduce liver inflammation and scarring, which could benefit people with NAFLD, but no one has yet investigated this.
Study design: A phase IV, open-label, randomised pilot study
Trial status: Closed
Chief Investigator: Dr Daniel Bradshaw
Start date: March 2018
End date: September 2021
Recruitment target: 60
Summary of study results: n/a
For further information contact:
E: I.Abramowicz@bsms.ac.uk
T: 01273 641446