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Vaccines and Immunotherapies (VIT)


CTNPT 027: the Lilac Study

The effect of metformin on HIV reservoir size in non-diabetic ART-treated patients

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About the study

Anti-HIV drugs have been very successful in improving the health of people living with HIV but these individuals still experience persistent health complications, even those who respond well to treatment. These health complications are in part due to chronic inflammation and HIV that remains hidden in immune cells, known as a viral reservoir. This study will evaluate the ability of metformin, a drug used to treat type 2 diabetes, to improve immune function and reduce the size of the HIV viral reservoir.

About the disease/condition

The increase in long-term health complications seen in those receiving treatment for HIV are a result of a number of factors. Some of these health issues are due to viral reservoirs, persistent activation of the immune system, and bacterial changes in the gut.

Metformin, the most popular medication for treating type 2 diabetes, is well tolerated and has no major side effects. It has been linked to anti-aging and weight reduction in people without diabetes. In those with HIV, Metformin might improve the recovery of the immune system in those on HIV treatment. It has also been shown to positively impact the bacteria in the gut and reduce inflammation, both of which could help to improve the long-term health of those living with HIV.

Study Approach

This study will last about 24 weeks and will include 22 participants. Metformin will be taken in pill form twice a day for the first 12 weeks of the study. Study participants will continue to take anti-HIV drugs during the entire 24-week study period. Testing will be conducted at the beginning, 12 weeks, and 24 weeks of the study. This will allow researchers to assess the impact of taking Metformin on immune function and if the effects of the medication continue after treatment is stopped.

Eligibility criteria

Inclusion Criteria:

  • HIV-1 positive male or female at least 18 years old
  • HIV-1 positive adult successfully treated with ART (anti-HIV treatment) for at least 3 years (the time necessary to establish a stable reservoir)
  • Individuals on a stable ART regimen for at least 3 months, with plasma viral load below the level of detection and with a CD4/CD8 ratio ≤ 0.7
  • Non-diabetic and pre-diabetic individuals
  • Able to understand and sign the informed consent form prior to screening

Exclusion Criteria:

  • Individuals with a known hypersensitivity/allergy to the metformin
  • Individuals who are actively participating in an experimental therapy study or who have received experimental therapy within the last 6 months
  • Individuals who are suffering from severe systemic diseases (uncontrolled hypertension, chronic renal failure), or active uncontrolled infections
  • Individuals having diabetes mellitus

Participating sites

Chronic Viral Illness Service
Royal Victoria Hospital
McGill University Health Centre (MUHC)
1001 Decarie Blvd., Room D02.4017
Montreal, Quebec, H4A 3J1
Canada

The Ottawa Hospital
501 Smyth Rd, Ottawa
ON K1H 8L6

Maple Leaf Medical Clinic
14 College St, Toronto
ON M5G 1K2

Additional Information

If you would like more information on this clinical study, please refer to the principal investigator.

Principal Investigator:

Jean-Pierre Routy, M.D., FRCPC
Chronic Viral Illness Service
McGill University Health Centre, Glen site
jean-pierre.routy@mcgill.ca

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