RecruitingPhase 4

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

United States100 participantsStarted 2025-04-07

Plain-language 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.

Who can participate

Age range

18 Years – 64 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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. * Serum CRP \> 3 mg/dL. * Glucose level between 70-180 mg/dL (non-fasting). * Hemoglobin A1c (HbA1c) of 5.0-6.4%. * CD4 count \> 200 cells/ml. * If HIV-positive, HIV viral load \< 200 copies/ml. * If HIV-positive, on anti-retroviral therapy (ART) for \>12 months. 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 dis…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Serum C-reactive Protein (CRP)

Timeframe: Baseline to Week 16

Trial details

NCT IDNCT06829238

SponsorUniversity of Alabama at Birmingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-11-30

Contact for this trial

Ellen Eaton, MD, MSPH

205-975-0661 eeaton@uabmc.edu

View on ClinicalTrials.gov More Systemic Inflammation trials