Metformin for Immune Dysregulation in Drug Users

((MET-IH) Trial)

Overseen By Dr. Kobie

Age: 18 - 65

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Alabama at Birmingham

Must not be taking: Metformin, Diabetes medications, Furosemide, others

Disqualifiers: Diabetes, Renal impairment, Liver disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

100 Participants Needed

Trial Summary

What is the purpose of this trial?

This randomized clinical trial (RCT) evaluates whether metformin can reduce systemic inflammation and improve immune function in individuals with a history of injection drug use, with or without HIV. Participants will receive metformin or placebo and undergo immune system assessments, including vaccine response evaluations.

Do I have to stop taking my current medications for the trial?

The trial requires that you stop taking metformin or other diabetes medications, as well as certain other medications like furosemide, nifedipine, ranolazine, vandetanib, or cimetidine if you are currently using them or have used them in the past 30 days.

Is metformin generally safe for use in humans?

Metformin is a well-established medication primarily used for type 2 diabetes and has been studied for its effects on the immune system in various conditions, showing good safety and tolerance. It has been used in research for conditions like cancer, autoimmune diseases, and HIV, indicating its potential safety across different health issues. ^{1 2 3 4 5}

How does the drug Metformin differ from other treatments for immune dysregulation in drug users?

Metformin is unique because it not only helps manage blood sugar levels in diabetes but also has potential immune-modulating effects, such as reducing T cell exhaustion and inflammation, which could be beneficial for immune dysregulation in drug users. This makes it different from other treatments that may not address these specific immune-related issues. ^{4 6 7 8 9}

Eligibility Criteria

This trial is for people who have used injection drugs and may or may not be living with HIV. It's designed to see if metformin can help reduce inflammation and improve their immune systems.

Inclusion Criteria

I have been on HIV medication for more than a year.

I am willing and able to follow the study rules and attend all required visits.

I am between 18 and 64 years old.

Exclusion Criteria

I have had metabolic acidosis before.

I am unable to understand and give consent for treatment.

Pregnant or nursing individuals

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Metformin or placebo for 16 weeks, with immune system assessments and vaccine administration

16 weeks

Regular visits for assessments and vaccine administration

Follow-up

Participants are monitored for immune response and safety after treatment

6 months

Treatment Details

Interventions

• Metformin

Trial Overview The study tests metformin against a placebo in reducing systemic inflammation and boosting immune function. Participants will also receive vaccines, Capvaxvie or Jynneos, to assess vaccine response as part of the immune evaluation.

Participant Groups

Group I: Metformin Group Experimental Treatment 3 Interventions

Participants will receive Metformin ER (500mg increasing to 1000mg) for 16 weeks to assess immune restoration and inflammatory response.

Group II: Placebo Group Placebo Group 3 Interventions

Control Group

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Modulation of Altered Immune Parameters IL-2 and TNF-α in Diabetic Animal Models: A Therapeutic Insinuation of Metformin Beyond Diabetes. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Metformin and Its Immune-Mediated Effects in Various Diseases. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Metformin generates profound alterations in systemic and tumor immunity with associated antitumor effects. [2022]

4. China pubmed.ncbi.nlm.nih.gov

Metformin may be a viable adjunctive therapeutic option to potentially enhance immune reconstitution in HIV-positive immunological non-responders. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Context-Dependent Pharmacological Effects of Metformin on the Immune System. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Short Communication: Metformin Reduces CD4 T Cell Exhaustion in HIV-Infected Adults on Suppressive Antiretroviral Therapy. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Metformin and Autoimmunity: A "New Deal" of an Old Drug. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Metformin inhibits the inflammatory response associated with cellular transformation and cancer stem cell growth. [2021]

9. Japan pubmed.ncbi.nlm.nih.gov

T helper 17 cells: A new actor on the stage of type 2 diabetes and aging? [2021]