RecruitingSystemic InflammationImmune DysregulationInjection Drug Use
Assessment of Metformin for Restoration of Immune Homeostasis in HIV+ and HIV- Individuals With a History of Injection Drug Use
Eligible age
18–64 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: University of Alabama at Birmingham
You may qualify if…
- ✓ 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).
You may not qualify if…
- ✕ 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.
Where it's recruiting
Alabama
Birmingham
Source: ClinicalTrials.gov · NCT06829238 · last updated 2026-04-22