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New treatment option for Systemic Inflammation
Official title Assessment of Metformin for Restoration of Immune Homeostasis in HIV+ and HIV- Individuals With a History of Injection Drug Use
ClinicalTrials.gov ID: NCT06829238
What this study is testing
What is Metformin?
Metformin is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for systemic inflammation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Time commitment: about 6 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 64
You may be able to join 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.
You likely can't join 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.
See the full eligibility 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.
- 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.
- Albumin \<3.5 g/dL.
- Prothrombin \>1.5× the upper limit of normal.
- AUDIT-C score ≥8.
- Hemoglobin \<9.0 g/L.
- Absolute neutrophil count \<1,000/mL.
- Platelet count \<100,000/mL.
- History of acute or chronic metabolic acidosis.
- Serum bicarbonate \<22 mEq/L.
- Anion gap \>10 mEq/L.
- Serum lactate \>2.2 mmol/L.
- Serum vitamin B12 \<250 pg/mL.
- History of chronic diarrhea.
- Current use of metformin or other diabetes medications.
- History of myocardial infarction, endocarditis, stroke, heart failure, chronic obstructive pulmonary disease, or sepsis.
- Use of medications such as furosemide, nifedipine, ranolazine, vandetanib, or cimetidine (current or within the past 30 days).
- Active hepatitis B infection.
- Hepatitis C infection within 6 months of study entry; individuals with prior hepatitis C must be at least 6 months post-treatment with direct-acting antivirals.
- Previous receipt of Jynneos or pneumococcal vaccine within the past two years (self-report).
- Severe allergic reaction to metformin, Jynneos, or Capvaxvie (self-report). Blood donations exceeding 450 mL in the 8 weeks prior to enrollment, accounting for study-related blood draws.
- Any medical, psychiatric, social condition, or responsibility that, in the investigator's judgment, could interfere with study procedures.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.