Metformin for Immune Dysregulation in Drug Users
((MET-IH) Trial)

Recruiting in Palo Alto (17 mi)

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: University of Alabama at Birmingham

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

This trial is for people who have used injection drugs and may or may not be living with HIV. It's designed to see if metformin can help reduce inflammation and improve their immune systems.

Inclusion Criteria

I have been on HIV medication for more than a year.

I am willing and able to follow the study rules and attend all required visits.

I am between 18 and 64 years old.

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Exclusion Criteria

I have had metabolic acidosis before.

I am unable to understand and give consent for treatment.

Pregnant or nursing individuals

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Treatment Details

Interventions

Metformin (Anti-diabetic agent)

Trial OverviewThe study tests metformin against a placebo in reducing systemic inflammation and boosting immune function. Participants will also receive vaccines, Capvaxvie or Jynneos, to assess vaccine response as part of the immune evaluation.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Metformin GroupExperimental Treatment3 Interventions

Participants will receive Metformin ER (500mg increasing to 1000mg) for 16 weeks to assess immune restoration and inflammatory response.

Group II: Placebo GroupPlacebo Group3 Interventions

Control Group