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Metformin Immunotherapy in HIV Infection

This study is currently recruiting participants.
See Contacts and Locations
Verified September 2016 by Jean-Pierre Routy, McGill University Health Center
Sponsor:
Information provided by (Responsible Party):
Jean-Pierre Routy, McGill University Health Center
ClinicalTrials.gov Identifier:
NCT02659306
First received: January 15, 2016
Last updated: September 12, 2016
Last verified: September 2016
  Purpose

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.


Condition Intervention Phase
HIV Infection Drug: Metformin Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Metformin on HIV Reservoir Size in Non-diabetic Antiretroviral Therapy (ART) Treated Participants: the Lilac Study

Resource links provided by NLM:


Further study details as provided by Jean-Pierre Routy, McGill University Health Center:

Primary Outcome Measures:
  • Decrease in the size of the HIV reservoir [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Change in the percentage of activated CD8 T-cells [ Time Frame: 12 weeks ]

Estimated Enrollment: 22
Study Start Date: September 2016
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Metformin
Assessment will be done at the baseline, during and after 12 week of metformin use.
Drug: Metformin
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. HIV-1 infected male or female adults greater than or equal to 18 years of age
  2. HIV-1 infected adults successfully treated with ART for at least 3 years (the time necessary to establish a stable reservoir)
  3. 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
  4. Non-diabetic (HbA1c < 5.9%) and pre-diabetic individuals (HbA1c between 6.0 and ≥ 6.4%), as defined by their glycosylated hemoglobin levels
  5. Able to understand and sign the informed consent form prior to screening

Exclusion Criteria:

  1. Individuals with a known hypersensitivity/allergy to the metformin
  2. Individuals who are actively participating in an experimental therapy study or who have received experimental therapy within the last 6 months
  3. Individuals who are suffering from severe systemic diseases (uncontrolled hypertension, chronic renal failure), or active uncontrolled infections
  4. Individuals having diabetes mellitus (HbA1c ≥ 6.5 %) as defined by the Canadian Clinical Practice Guidelines for the Prevention and Management of Diabetes
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02659306

Contacts
Contact: Natacha Cotta-Grand, PhD (514) 934 -1934 ext 32547 natacha.cotta-grand@muhc.mcgill.ca

Locations
Canada, Quebec
Chronic Viral Illness Service, McGill University Health Centre Recruiting
Montreal, Quebec, Canada, H4A 3J1
Contact: Natacha Cotta-Grand, PhD    (514) 934-1934 ext 32547    natacha.cotta-grand@muhc.mcgill.ca   
Sponsors and Collaborators
McGill University Health Center
Investigators
Principal Investigator: Jean-Pierre Routy, MD; FRCPC McGill University Health Center
  More Information

Additional Information:
Publications:
Responsible Party: Jean-Pierre Routy, Professor, McGill University Health Center
ClinicalTrials.gov Identifier: NCT02659306     History of Changes
Other Study ID Numbers: CTNPT027
Study First Received: January 15, 2016
Last Updated: September 12, 2016

Additional relevant MeSH terms:
Infection
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 27, 2017