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HIV InfectionPhase 1NCT02659306

Metformin Immunotherapy in HIV Infection

A Phase 1 study testing Metformin in people with HIV Infection, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infection
What is being tested?
Metformin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteCanada
Study dates
Sep 2016to Feb 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Chronic Viral Illness Service, McGill University Health Centre

    Montreal, Quebec, H4A 3J1

Other trials in Canada

About this study

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

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.

Read more

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.

Conditions
HIV Infection
Being tested
Metformin
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MetforminDrug

    Also called Glucophage

    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.

Study groups in NCT02659306
Study groupRoleWhat they receive
MetforminExperimentalAssessment will be done at the baseline, during and after 12 week of metformin use.
Receives: Drug: Metformin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Decrease in the size of the HIV reservoir

    Measured: 12 weeks

Secondary outcomes (1)

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

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2016 (estimated)
  2. Study startSep 2016
  3. Primary completion14 Aug 2018
  4. Study completionFeb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02659306
Sponsor's protocol ID
CTNPT027
Status last verified
Mar 2023
First submitted
15 Jan 2016
Last updated
14 Mar 2023
Results posted
No
Data monitoring committee
Yes

Publications

  • Routy JP, Mehraj V, Cao W. HIV immunotherapy comes of age: implications for prevention, treatment and cure. Expert Rev Clin Immunol. 2016;12(2):91-4. doi: 10.1586/1744666X.2016.1112269. Epub 2015 Dec 2.

    PubMed 26629806

  • Lu W, Mehraj V, Vyboh K, Cao W, Li T, Routy JP. CD4:CD8 ratio as a frontier marker for clinical outcome, immune dysfunction and viral reservoir size in virologically suppressed HIV-positive patients. J Int AIDS Soc. 2015 Jun 29;18(1):20052. doi: 10.7448/IAS.18.1.20052. eCollection 2015.

    PubMed 26130226

  • Vyboh K, Jenabian MA, Mehraj V, Routy JP. HIV and the gut microbiota, partners in crime: breaking the vicious cycle to unearth new therapeutic targets. J Immunol Res. 2015;2015:614127. doi: 10.1155/2015/614127. Epub 2015 Feb 22.

    PubMed 25759844

  • Dagenais-Lussier X, Mouna A, Routy JP, Tremblay C, Sekaly RP, El-Far M, Grevenynghe Jv. Current topics in HIV-1 pathogenesis: The emergence of deregulated immuno-metabolism in HIV-infected subjects. Cytokine Growth Factor Rev. 2015 Dec;26(6):603-13. doi: 10.1016/j.cytogfr.2015.09.001. Epub 2015 Sep 8.

    PubMed 26409789

  • Routy JP, Isnard S, Mehraj V, Ostrowski M, Chomont N, Ancuta P, Ponte R, Planas D, Dupuy FP, Angel JB; Lilac Study Group. Effect of metformin on the size of the HIV reservoir in non-diabetic ART-treated individuals: single-arm non-randomised Lilac pilot study protocol. BMJ Open. 2019 Apr 20;9(4):e028444. doi: 10.1136/bmjopen-2018-028444.

    PubMed 31005944

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Metformin in people with HIV Infection, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Decrease in the size of the HIV reservoir (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02659306, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.

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