Anti-HIV drugs cut down the number of serious infections that people with HIV get. However,
some subjects taking anti-HIV drugs do not achieve adequate cluster of differentiation 4
(CD4) recovery and decrease in elevated cluster of differentiation 8 (CD8) cells. Such
patients with a low CD4/CD8 ratio remain at risk for developing acquired immune deficiency
syndrome (AIDS) and non-AIDS-related complications. Two of the most important factors
associated with low CD4/CD8 ratio include: the persistence of HIV on ART and inflammation.
Metformin, the most widely used medication to treat type 2 diabetes, is well tolerated with
minimal side effects. It has been linked to anti-aging and weight reducing properties in
non-diabetic persons. Because of its ability to improve immune functions, metformin could be
a promising addition to ART in HIV patients. It is also reported to change the composition of
microbes in the gut which may improve inflammation.
PURPOSES OF THE STUDY
The purposes of this study are to find out if:
1. metformin can be combined with anti-HIV drugs to reduce the amount of hidden virus in
the body;
2. metformin can be combined with anti-HIV drugs to improve immune function.
3. metformin can be combined with anti-HIV drugs to impact CD4 T cell count and CD4/CD8 T
cell ratio during treatment and after its discontinuation
4. metformin can change the composition of the bacteria in the gut which may improve
inflammation.
For this purpose, the investigators will add metformin at the usual antidiabetic dose for 12
weeks for patients receiving stable ART, having a CD4/CD8 ratio below 0.7.
Approximately 22 participants will be enrolled in this study at the Chronic Viral Illness
Service of the McGill University Health Centre, the Ottawa Hospital and the Maple Leaf
Medical Clinic (Toronto). This study will last about 24 weeks; metformin treatment will be
for 12 weeks. In order to be eligible for the study, the participants must be 18 years of age
or older, have an undetectable viral load (the quantity of the HIV virus in the blood must be
less than 50 copies/ml) for at least 3 months and have a CD4/CD8 ratio of less than 0.7. All
participants will also be asked to give blood and stool samples and optional colon mucosal
biopsy samples (before and after metformin supplementation) to study the size of the viral
reservoir and the amount of T cell activation and changes in gut microbiota composition.
Phase:
Phase 1
Details
Lead Sponsor:
McGill University Health Center McGill University Health Centre/Research Institute of the McGill University Health Centre