A randomised controlled trial of adding MAraViroc and/or METformin for hepatic steatosis in people living with HIV-1 infection (MAVMET)
We would like to invite you to take part in a research study, MAVMET. This study is testing different treatments to try and reduce the amount of fat in your liver.
Why are we doing the study in people with HIV? Studies suggest that older people with HIV who have taken antiretroviral therapy (ART) for many years are more likely to have fat in their liver. We don’t know why this is, and we don’t know what to do about it. People who have gained weight around the waist while taking ART are more likely to have fat in their liver. High levels of fat in the liver may result in damage to the liver (cirrhosis).
What are we trying to find out in the MAVMET study? Whether adding maraviroc, an ART medication, and metformin, amedicine to treat diabetes, can reduce the amount of fat in your liver.
How do we go about this? This study will compare 4 groups: the maraviroc group (2 tablets/day), the metformin group (2 tablets/day), the maraviroc and metformin group (4 tablets/day), and the control group (no extra tablets). Everyone on the studywill continue their current ART. If you take part, you will be one of 88 people in the UK doing the study. The study lasts for one year.
What will I need to do if I take part? Depending on which group you will be allocated to, you will be asked to take 0, 2 or 4 extra tablets (none, one or two tablets twice a day). There will be 7 clinic visits (2 to 5 extra visits compared to your usual HIV care). Atthese visits, you will be asked for an update on your health, have a clinical examination and a blood test. In addition, you will get an MRI scan at the beginning and at the end of the study to determine the amount of fat in your liver. These scans will be done inCentral London at University College London Hospital (UCLH).
There is one other optional scan. This involves having a brain MRI scan done at the Institute of Neurology, this will take approximately one hour. The Institute of Neurology is a short walk from UCLH.
You will be reimbursed for your travel to these scans.
What are the possible side effects? Both medicines in this study are licensed for treatment of HIV (maraviroc) or diabetes (metformin) and have been used for many years for these conditions. Both medicines have a very good safety record and few side effects.
What if I don’t want to take part? Your participation is entirely voluntary, and it is up to you to decide whether or not to takepart. If you do decide to take part you can withdraw at any time without giving a reason. This will not affect the care you get from your clinic in any way.
What do I do next? If after reading this summary you are interested in taking part in MAVMET, please email Marcia – firstname.lastname@example.org