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NCT Number: NCT02659306

Metformin Immunotherapy in HIV Infection

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.

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Key information

Conditions

HIV Infection Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Chronic Viral Illness Service, McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • HIV-1 infected male or female adults greater than or equal to 18 years of age
  • HIV-1 infected adults successfully treated with ART 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 (HbA1c < 5.9%) and pre-diabetic individuals (HbA1c between 6.0 and ≥ 6.4%), as defined by their glycosylated hemoglobin levels
  • 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 (HbA1c ≥ 6.5 %) as defined by the Canadian Clinical Practice Guidelines for the Prevention and Management of Diabetes

Treatment and study plan

metformin

Drug

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 names: Glucophage

Primary outcomes

  1. Decrease in the size of the HIV reservoir

    Time frame: 12 weeks

Secondary outcomes

  1. Change in the percentage of activated CD8 T-cells

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Other

Registry information

Official study title

The Effect of Metformin on HIV Reservoir Size in Non-diabetic Antiretroviral Therapy (ART) Treated Participants: the Lilac Study

Important dates

Study start
2016
Primary completion
2018
Study completion
2020
First posted
Jan 20, 2016
Registry last updated
Mar 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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