Study of Metformin to Improve Immune Function in Adults 18-64 With History of Injection Drug Use and HIV

What this Trial Is About

Researchers are evaluating whether metformin can reduce systemic inflammation and restore immune balance in adults aged 18 to 64 with a history of injection drug use, including those with or without HIV. This Phase 4 randomized clinical trial focuses on understanding metformins impact on immune dysregulation and inflammation. Participants will be assessed for immune responses after receiving vaccines and study treatment. Participants will be randomly assigned to receive either metformin extended-release, starting at 500 mg and increasing to 1000 mg daily, or a placebo for 16 weeks. During this period, all participants will receive the Jynneos MPOX vaccine and the Capvaxvie PCV21, pneumococcal vaccine. The study monitors immune system markers and vaccine responses throughout the treatment and for six months after enrollment. Throughout the study, participants will undergo blood tests to measure markers such as serum C-reactive protein, exhausted B and T cells, and specific vaccine antibody levels. Researchers will track changes from baseline to specific weeks during and after treatment. Participants are expected to comply with study procedures and attend scheduled visits for assessments over the study duration, which includes the 16-week treatment phase and follow-up monitoring.

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