RECRUITING

Assessment of Metformin for Restoration of Immune Homeostasis in HIV+ and HIV- Individuals with a History of Injection Drug Use

Conditions

Systemic Inflammation Immune Dysregulation Injection Drug Use HIV Metformin Immune restoration Vaccine response People who inject drugs (PWID)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Assessment of Metformin for Restoration of Immune Homeostasis in HIV+ and HIV- Individuals with a History of Injection Drug Use (MET-IH)

Quick Facts

Study Start:2025-03-07

Study Completion:2029-11-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06829238

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 64 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Dr. Eaton

CONTACT

205-975-0661

eeaton@uabmc.edu

Dr. Kobie

CONTACT

205-934-8800

jjkobie@uabmc.edu

Study Locations (Sites)

University of Alabama at Birmingham

Birmingham, Alabama, 35294

United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-07

Study Completion Date2029-11-30

Study Record Updates

Study Start Date2025-03-07

Study Completion Date2029-11-30

Terms related to this study

Keywords Provided by Researchers

Metformin
Immune restoration
Vaccine response
People who inject drugs (PWID)

Additional Relevant MeSH Terms

Systemic Inflammation
Immune Dysregulation
Injection Drug Use
HIV