Trials / Recruiting
RecruitingNCT06829238
Assessment of Metformin for Restoration of Immune Homeostasis in HIV+ and HIV- Individuals With a History of Injection Drug Use
Assessment of Metformin for Restoration of Immune Homeostasis in HIV+ and HIV- Individuals With a History of Injection Drug Use (MET-IH)
- Status
- Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- University of Alabama at Birmingham · Academic / Other
- Sex
- All
- Age
- 18 Years – 64 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
The study aims to assess the impact of metformin on immune dysregulation among 100 adults (ages 18-64) with a history of injection drug use. Participants will be randomized 1:1 to metformin (500mg increasing to 1000mg) or placebo for 16 weeks, during which they will receive Jynneos (MPOX) and Capvaxvie (PCV21, pneumococcal) vaccines. Immunologic responses will be monitored over 6 months post-enrollment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2025-04-07
- Primary completion
- 2028-11-30
- Completion
- 2029-11-30
- First posted
- 2025-02-17
- Last updated
- 2025-04-09
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06829238. Inclusion in this directory is not an endorsement.