Actively Recruiting
Assessment of Metformin for Restoration of Immune Homeostasis in HIV+ and HIV- Individuals With a History of Injection Drug Use
Led by University of Alabama at Birmingham · Updated on 2026-04-22
100
Participants Needed
1
Research Sites
242 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
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.
CONDITIONS
Official 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 provided
- Willing to comply with all study procedures and available for study duration
- Aged 18 to 64 years
- Weigh at least 110 lbs
- Body Mass Index (BMI) between 18.5 and 40, with potential approval for BMI over 40 if in good health
- Willingness to receive Jynneos (MPOX) and Capvaxvie (PCV21) vaccines
- Able to take oral medication and willing to follow metformin treatment
- History of injection opioid, amphetamine, and/or cocaine use within the past 10 years (self-reported)
- Use of non-prescription opioid, amphetamine, and/or cocaine within past 30 days (self-reported)
- Clinically confirmed urine drug screen positive for opioid, amphetamine, and/or cocaine within past 30 days
- Serum C-reactive Protein (CRP) level greater than 3 mg/dL
- Glucose level between 70 and 180 mg/dL (non-fasting)
- Hemoglobin A1c 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 provide informed consent
- Refusal or inability to have blood drawn
- Diagnosed bleeding disorder requiring precautions
- Pregnant or nursing individuals
- Diabetes mellitus diagnosis
- History of severe renal impairment or estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73m²
- Creatinine clearance below 60 mL/min
- History of liver disease
- ALT or AST levels more than 3 times the upper limit of normal
- Total bilirubin over 1.4 mg/dL
- Albumin below 3.5 g/dL
- Prothrombin more than 1.5 times the upper limit of normal
- AUDIT-C score of 8 or higher
- Hemoglobin below 9.0 g/L
- Absolute neutrophil count below 1,000/mL
- Platelet count below 100,000/mL
- History of acute or chronic metabolic acidosis
- Serum bicarbonate below 22 mEq/L
- Anion gap above 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 myocardial infarction, endocarditis, stroke, heart failure, COPD, or sepsis
- Use of specific medications (furosemide, nifedipine, ranolazine, vandetanib, cimetidine) currently or within past 30 days
- Active hepatitis B infection
- Hepatitis C infection within 6 months; prior hepatitis C treatment must be at least 6 months ago
- Receipt of Jynneos or pneumococcal vaccine within past two years
- Severe allergic reaction to metformin, Jynneos, or Capvaxvie
- Blood donations exceeding 450 mL in 8 weeks prior to enrollment
- Any medical, psychiatric, social condition, or responsibility that could interfere with study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
J
James Kobie, PhD
CONTACT
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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