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Assessment of Metformin for Restoration of Immune Homeostasis in HIV+ and HIV- Individuals With a History of Injection Drug Use | Clinical Trials | Clareo Health

RECRUITINGPHASE4

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)

NCT06829238•University of Alabama at Birmingham

View on ClinicalTrials.gov

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.

Detailed Description

The study aims to assess the impact of metformin on immune dysregulation among 100 adults (ages 18-64) with a history of injection drug use. Participants will be randomized 1:1 to metformin (500mg increasing to 1000mg) or placebo for 16 weeks, during which they will receive Jynneos (MPOX) and Capvaxvie (PCV21, pneumococcal) vaccines. Immunologic responses will be monitored over 6 months post-enrollment.

Eligibility

Age

18 - 64 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Provision of signed and dated informed consent.
•Stated willingness to comply with all study procedures and availability for the study duration.
•Aged 18 to 64 years old.
•Weight of at least 110 lbs.
•Body Mass Index (BMI) of 18.5-40. Enrollment of individuals with BMI \>40, deemed in good health, may be considered with approval.
•Willingness to receive Jynneos (MPOX) and Capvaxvie vaccines.
•Ability to take oral medication and willingness to adhere to the metformin treatment regimen.
•History of injection opioid, amphetamine, and/or cocaine use within the past 10 years (self-report).
•Use of non-prescription opioid, amphetamine, and/or cocaine within the past 30 days (self-report).
•Clinically confirmed urine drug screen for opioid, amphetamine, and/or cocaine within the past 30 days.
+6 more criteria

Exclusion Criteria

•Inability to give informed consent.
•Refusal or inability to have blood drawn.
•Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, platelet disorder requiring precautions).
•Pregnant or nursing individuals.
•Diabetes mellitus.
•History of severe renal impairment or eGFR \<60 mL/min/1.73m².
•Creatinine clearance \<60 mL/min.
•History of liver disease.
•ALT/AST \> 3× the upper limit of normal.
•Total bilirubin \>1.4 mg/dL.
+20 more criteria

Locations (1)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Key Dates

Start Date

April 7, 2025

Primary Completion Date

November 30, 2028

Completion Date

November 30, 2029

Last Updated

April 9, 2025

Enrollment

100

ESTIMATED participants

Conditions

Systemic InflammationImmune DysregulationInjection Drug UseHIV

Interventions

Metformin

DRUG

Placebo

DRUG

Jynneos

BIOLOGICAL

Capvaxvie

BIOLOGICAL

Contacts

Dr. Eaton

CONTACT

205-975-0661 eeaton@uabmc.edu

Dr. Kobie

CONTACT

205-934-8800 jjkobie@uabmc.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 9, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Long-acting Cabotegravir Injectable Pre-exposure Prophylaxis for People Who Inject Drugs

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