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

Study acronym: (MET-IH)
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site contact updatedv6
  2. Start date changed from estimate of Apr 15, 2025 to Apr 7, 2025v5
  3. Start date: Apr 1, 2025 to Apr 15, 2025v4
  4. Start date: Mar 7, 2025 to Apr 1, 2025v3
  5. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Mar 1, 2025 to Mar 7, 2025 · Site details revisedv2 Show 2 more changesShow less
    • Start date changed from estimate of Mar 1, 2025 to Mar 7, 2025
    • Site details revised
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06829238
Lead Sponsor University of Alabama at Birmingham
Collaborators: National Institute on Drug Abuse (NIDA)
Conditions Systemic Inflammation, Immune Dysregulation, Injection Drug Use, HIV
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov