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RECRUITING
NCT06829238
PHASE4

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

Sponsor: University of Alabama at Birmingham

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 64 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2025-04-07

Completion Date

2029-11-30

Last Updated

2025-04-09

Healthy Volunteers

No

Interventions

DRUG

Metformin

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

DRUG

Placebo

Participants will receive placebo for 16 weeks and assess immune restoration and inflammatory response.

BIOLOGICAL

Jynneos

All participants will take a Jynneos (MPOX) vaccine.

BIOLOGICAL

Capvaxvie

All participants will take a Capvaxvie (PCV21, pneumococcal) vaccine.

Locations (1)

University of Alabama at Birmingham

Birmingham, Alabama, United States