RecruitingPhase 4NCT06829238

Assessment of Metformin for Restoration of Immune Homeostasis in HIV+ and HIV- Individuals With a History of Injection Drug Use

Assessment of Metformin for Restoration of Immune Homeostasis in HIV+ and HIV- Individuals With a History of Injection Drug Use (MET-IH)


Sponsor

University of Alabama at Birmingham

Enrollment

100 participants

Start Date

Apr 7, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether metformin — a widely used diabetes medication — can help restore healthy immune system function in people who have a history of injection drug use, with or without HIV. The study also includes two approved vaccines (for mpox and pneumococcal disease) to measure immune response. **You may be eligible if...** - You are between 18 and 64 years old and weigh at least 110 lbs - You have a history of injecting opioids, amphetamines, or cocaine within the past 10 years - Your BMI is between 18.5 and 40 (or slightly above with medical approval) - You are willing to take metformin orally and receive the two study vaccines - You are HIV-positive or HIV-negative (both groups are included) **You may NOT be eligible if...** - You currently have uncontrolled diabetes or are already on metformin - You have significant kidney problems (metformin requires normal kidney function) - You have a condition that makes vaccination unsafe - You are pregnant or planning to become pregnant during the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMetformin

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

DRUGPlacebo

Participants will receive placebo for 16 weeks and assess immune restoration and inflammatory response.

BIOLOGICALJynneos

All participants will take a Jynneos (MPOX) vaccine.

BIOLOGICALCapvaxvie

All participants will take a Capvaxvie (PCV21, pneumococcal) vaccine.


Locations(1)

University of Alabama at Birmingham

Birmingham, Alabama, United States

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NCT06829238


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