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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-64
SponsorUniversity of Alabama at Birmingham

About 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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Metformin
  • Placebo
  • Jynneos
  • Capvaxvie

Treatment groups

100 Participants
are divided into 2 treatment groups

Locations

1
University of Alabama at Birmingham35294, BirminghamAlabama, United States

Sponsors and collaborators

University of Alabama at Birmingham

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator