Metformin Immunotherapy in HIV Infection
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|ClinicalTrials.gov Identifier: NCT02659306|
Recruitment Status : Unknown
Verified March 2018 by Jean-Pierre Routy, McGill University Health Centre/Research Institute of the McGill University Health Centre.
Recruitment status was: Active, not recruiting
First Posted : January 20, 2016
Last Update Posted : March 22, 2018
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:
- metformin can be combined with anti-HIV drugs to reduce the amount of hidden virus in the body;
- metformin can be combined with anti-HIV drugs to improve immune function.
- 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
- 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.
|Condition or disease||Intervention/treatment||Phase|
|HIV Infection||Drug: Metformin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Metformin on HIV Reservoir Size in Non-diabetic Antiretroviral Therapy (ART) Treated Participants: the Lilac Study|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||December 2018|
Assessment will be done at the baseline, during and after 12 week of metformin use.
Metformin hydrochloride is a white to off-white crystalline compound formulated as tablets for oral consumption; tablets contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride. Only 500 mg and 850 mg tablets will be used for this study.
Other Name: Glucophage
- Decrease in the size of the HIV reservoir [ Time Frame: 12 weeks ]
- Change in the percentage of activated CD8 T-cells [ Time Frame: 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02659306
|Chronic Viral Illness Service, McGill University Health Centre|
|Montreal, Quebec, Canada, H4A 3J1|
|Principal Investigator:||Jean-Pierre Routy, MD; FRCPC||McGill University Health Centre/Research Institute of the McGill University Health Centre|