Actively Recruiting
Assessment of Metformin for Restoration of Immune Homeostasis in HIV+ and HIV- Individuals With a History of Injection Drug Use (MET-IH)
Led by University of Alabama at Birmingham · Updated on 2026-04-22
100
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
University of Alabama at Birmingham
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether metformin can reduce systemic inflammation and restore immune balance in adults aged 18 to 64 with a history of injection drug use, including those with or without HIV. This Phase 4 randomized clinical trial focuses on understanding metformin's impact on immune dysregulation and inflammation. Participants will be assessed for immune responses after receiving vaccines and study treatment. Participants will be randomly assigned to receive either metformin extended-release, starting at 500 mg and increasing to 1000 mg daily, or a placebo for 16 weeks. During this period, all participants will receive the Jynneos (MPOX) vaccine and the Capvaxvie (PCV21, pneumococcal) vaccine. The study monitors immune system markers and vaccine responses throughout the treatment and for six months after enrollment. Throughout the study, participants will undergo blood tests to measure markers such as serum C-reactive protein, exhausted B and T cells, and specific vaccine antibody levels. Researchers will track changes from baseline to specific weeks during and after treatment. Participants are expected to comply with study procedures and attend scheduled visits for assessments over the study duration, which includes the 16-week treatment phase and follow-up monitoring.
CONDITIONS
Brief Title
Assessment of Metformin for Restoration of Immune Homeostasis in HIV+ and HIV- Individuals With a History of Injection Drug Use
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent.
- Willingness to comply with study procedures and be available for the study duration.
- Age between 18 and 64 years.
- Weight of at least 110 lbs.
- Body Mass Index (BMI) between 18.5 and 40; BMI over 40 may be considered with approval.
- Willingness to receive Jynneos (MPOX) and Capvaxvie vaccines.
- Ability to take oral medication and follow metformin treatment.
- History of injection opioid, amphetamine, or cocaine use within the past 10 years.
- Use of non-prescription opioids, amphetamines, or cocaine in the past 30 days.
- Positive urine drug screen for opioids, amphetamines, or cocaine within the past 30 days.
- Serum C-reactive protein (CRP) greater than 3 mg/dL.
- Glucose level between 70 and 180 mg/dL (non-fasting).
- Hemoglobin A1c (HbA1c) between 5.0% and 6.4%.
- CD4 count greater than 200 cells/ml.
- If HIV-positive, viral load less than 200 copies/ml.
- If HIV-positive, on anti-retroviral therapy for more than 12 months.
You will not qualify if you...
- Unable to give informed consent.
- Refusal or inability to have blood drawn.
- Diagnosed bleeding disorders requiring precautions.
- Pregnant or nursing individuals.
- Diabetes mellitus.
- Severe renal impairment or eGFR less than 60 mL/min/1.73m².
- Creatinine clearance below 60 mL/min.
- History of liver disease.
- Elevated liver enzymes (ALT/AST more than 3 times normal).
- Total bilirubin above 1.4 mg/dL.
- Albumin less than 3.5 g/dL.
- Prothrombin more than 1.5 times normal.
- AUDIT-C score 8 or higher.
- Hemoglobin below 9.0 g/L.
- Absolute neutrophil count below 1,000/mL.
- Platelet count below 100,000/mL.
- History of metabolic acidosis.
- Serum bicarbonate below 22 mEq/L.
- Anion gap over 10 mEq/L.
- Serum lactate above 2.2 mmol/L.
- Serum vitamin B12 below 250 pg/mL.
- History of chronic diarrhea.
- Current use of metformin or other diabetes medications.
- History of serious heart or lung conditions.
- Use of certain medications like furosemide or nifedipine in the past 30 days.
- Active hepatitis B infection.
- Recent hepatitis C infection or recent treatment.
- Receipt of Jynneos or pneumococcal vaccine in the past two years.
- Severe allergic reactions to study drugs or vaccines.
- Recent large blood donations.
- Any condition that may interfere with study procedures as judged by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 16 weeks
Participants receive metformin or placebo for 16 weeks to assess immune restoration and inflammatory response. During this period, participants also receive Jynneos (MPOX) and Capvaxvie (PCV21, pneumococcal) vaccines.
Weekly visits for up to 16 weeks
Duration - Approximately 6 months
Participants are monitored for immunologic responses and safety for up to 6 months after enrollment.
Monthly visits for up to 6 months post enrollment
Trial Site Locations
Total: 1 location
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
Research Team
E
Ellen Eaton, MD, MSPH
J
James Kobie, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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