NCT06829238 Assessment of Metformin for Restoration of Immune Homeostasis in HIV+ and HIV- Individuals With a History of Injection Drug Use
| NCT ID | NCT06829238 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Alabama at Birmingham |
| Condition | Systemic Inflammation |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-04-07 |
| Primary Completion | 2028-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 100 participants in total. It began in 2025-04-07 with a primary completion date of 2028-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06829238 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 64 Years, studying Systemic Inflammation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06829238 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06829238 currently recruiting?
Yes, NCT06829238 is actively recruiting participants. Contact the research team at eeaton@uabmc.edu for enrollment information.
Where is the NCT06829238 trial being conducted?
This trial is being conducted at Birmingham, United States.
Who is sponsoring the NCT06829238 clinical trial?
NCT06829238 is sponsored by University of Alabama at Birmingham. The trial plans to enroll 100 participants.