NCT06829238View on ClinicalTrials.gov

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

PHASE4RecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

April 7, 2025

Primary Completion Date

November 30, 2028

Study Completion Date

November 30, 2029

Conditions
Systemic InflammationImmune DysregulationInjection Drug UseHIV
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.

Trial Locations (1)

35294

RECRUITING

University of Alabama at Birmingham, Birmingham

All Listed Sponsors
collaborator

National Institute on Drug Abuse (NIDA)

NIH

lead

University of Alabama at Birmingham

OTHER