[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100579818":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":42,"locations":52,"responsibleParty":69,"collaborators":73,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":28,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":100,"overallStatus":54,"whyStopped":28,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"University of Alabama at Birmingham","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Metformin Group","EXPERIMENTAL","Participants will receive Metformin ER (500mg increasing to 1000mg) for 16 weeks to assess immune restoration and inflammatory response.",[13,14,15],"Drug: Metformin","Biological: Jynneos","Biological: Capvaxvie",{"label":17,"type":18,"description":19,"interventionNames":20},"Placebo Group","PLACEBO_COMPARATOR","Control Group",[21,14,15],"Drug: Placebo",[23,29,33,38],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Metformin","Participants will receive Metformin ER (500mg increasing to 1000mg) or placebo for 16 weeks to assess immune restoration and inflammatory response.",[9],null,{"type":24,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"Placebo","Participants will receive placebo for 16 weeks and assess immune restoration and inflammatory response.",[17],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":28},"BIOLOGICAL","Jynneos","All participants will take a Jynneos (MPOX) vaccine.",[9,17],{"type":34,"name":39,"description":40,"armGroupLabels":41,"otherNames":28},"Capvaxvie","All participants will take a Capvaxvie (PCV21, pneumococcal) vaccine.",[9,17],[43,48],{"name":44,"role":45,"phone":46,"phoneExt":28,"email":47},"Ellen Eaton, MD, MSPH","CONTACT","205-975-0661","eeaton@uabmc.edu",{"name":49,"role":45,"phone":50,"phoneExt":28,"email":51},"James Kobie, PhD","205-934-8800","jjkobie@uabmc.edu",[53],{"facility":5,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"RECRUITING","Birmingham","Alabama","35294","United States","US",{"type":61,"coordinates":62},"Point",[63,64],-86.80249,33.52066,{"lat":64,"lon":63},[67,68],{"name":44,"role":45,"phone":46,"phoneExt":28,"email":47},{"name":49,"role":45,"phone":28,"phoneExt":28,"email":51},{"type":70,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"PRINCIPAL_INVESTIGATOR","Ellen Eaton","Dr. Ellen Eaton",[74],{"name":75,"class":76},"National Institute on Drug Abuse (NIDA)","NIH","100579818","phase-4-assessment-of-metformin-for-restoration-of-immune-homeostasis-in-hiv-and-hiv--individuals-with-a-history-of-injection-drug-use-100579818",false,"NCT06829238","Assessment of Metformin for Restoration of Immune Homeostasis in HIV+ and HIV- Individuals With a History of Injection Drug Use","Assessment of Metformin for Restoration of Immune Homeostasis in HIV+ and HIV- Individuals With a History of Injection Drug Use (MET-IH)","(MET-IH)","Inclusion Criteria:\n\n* Provision of signed and dated informed consent.\n* Stated willingness to comply with all study procedures and availability for the study duration.\n* Aged 18 to 64 years old.\n* Weight of at least 110 lbs.\n* Body Mass Index (BMI) of 18.5-40. Enrollment of individuals with BMI \\>40, deemed in good health, may be considered with approval.\n* Willingness to receive Jynneos (MPOX) and Capvaxvie vaccines.\n* Ability to take oral medication and willingness to adhere to the metformin treatment regimen.\n* History of injection opioid, amphetamine, and\u002For cocaine use within the past 10 years (self-report).\n* Use of non-prescription opioid, amphetamine, and\u002For cocaine within the past 30 days (self-report).\n* Clinically confirmed urine drug screen for opioid, amphetamine, and\u002For cocaine within the past 30 days.\n* Serum CRP \\> 3 mg\u002FdL.\n* Glucose level between 70-180 mg\u002FdL (non-fasting).\n* Hemoglobin A1c (HbA1c) of 5.0-6.4%.\n* CD4 count \\> 200 cells\u002Fml.\n* If HIV-positive, HIV viral load \\\u003C 200 copies\u002Fml.\n* If HIV-positive, on anti-retroviral therapy (ART) for \\>12 months.\n\nExclusion Criteria:\n\n* Inability to give informed consent.\n* Refusal or inability to have blood drawn.\n* Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, platelet disorder requiring precautions).\n* Pregnant or nursing individuals.\n* Diabetes mellitus.\n* History of severe renal impairment or eGFR \\\u003C60 mL\u002Fmin\u002F1.73m².\n* Creatinine clearance \\\u003C60 mL\u002Fmin.\n* History of liver disease.\n* ALT\u002FAST \\> 3× the upper limit of normal.\n* Total bilirubin \\>1.4 mg\u002FdL.\n* Albumin \\\u003C3.5 g\u002FdL.\n* Prothrombin \\>1.5× the upper limit of normal.\n* AUDIT-C score ≥8.\n* Hemoglobin \\\u003C9.0 g\u002FL.\n* Absolute neutrophil count \\\u003C1,000\u002FmL.\n* Platelet count \\\u003C100,000\u002FmL.\n* History of acute or chronic metabolic acidosis.\n* Serum bicarbonate \\\u003C22 mEq\u002FL.\n* Anion gap \\>10 mEq\u002FL.\n* Serum lactate \\>2.2 mmol\u002FL.\n* Serum vitamin B12 \\\u003C250 pg\u002FmL.\n* History of chronic diarrhea.\n* Current use of metformin or other diabetes medications.\n* History of myocardial infarction, endocarditis, stroke, heart failure, chronic obstructive pulmonary disease, or sepsis.\n* Use of medications such as furosemide, nifedipine, ranolazine, vandetanib, or cimetidine (current or within the past 30 days).\n* Active hepatitis B infection.\n* 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.\n* Previous receipt of Jynneos or pneumococcal vaccine within the past two years (self-report).\n* 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.\n* Any medical, psychiatric, social condition, or responsibility that, in the investigator's judgment, could interfere with study procedures.","ALL","18 Years","64 Years",{"count":89,"type":90},100,"ESTIMATED","INTERVENTIONAL",[93],"PHASE4","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.",[96,97,98,99],"Systemic Inflammation","Immune Dysregulation","Injection Drug Use","HIV",[25,101,102,103],"Immune restoration","Vaccine response","People who inject drugs (PWID)","2026-04-17",{"date":106,"type":107},"2026-04-22","ACTUAL",{"date":109,"type":107},"2025-04-07",{"date":111,"type":90},"2029-11-30",{"name":5,"class":6},1]