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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT06829238
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • HIV
  • Immune Dysregulation
  • Injection Drug Use
  • Systemic Inflammation

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • Metformin — DRUG
    Participants will receive Metformin ER (500mg increasing to 1000mg) or placebo for 16 weeks to assess immune restoration and inflammatory response.
  • Placebo — DRUG
    Participants will receive placebo for 16 weeks and assess immune restoration and inflammatory response.
  • Jynneos — BIOLOGICAL
    All participants will take a Jynneos (MPOX) vaccine.
  • Capvaxvie — BIOLOGICAL
    All participants will take a Capvaxvie (PCV21, pneumococcal) vaccine.

Study Details

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.

Key Dates

Start date
Apr 7, 2025
Status verified
Apr 2026
Primary completion
Nov 30, 2028
Completion
Nov 30, 2029

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Metformin Group
    Participants will receive Metformin ER (500mg increasing to 1000mg) for 16 weeks to assess immune restoration and inflammatory response.
  • Placebo Comparator: Placebo Group
    Control Group

Primary Outcome Measure

Change in Serum C-reactive Protein (CRP) [ Time Frame: Baseline to Week 16 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294
Ellen Eaton, MD, MSPH
[email protected]
205-975-0661
James Kobie, PhD
[email protected]

Find similar trials in Birmingham, AL

By condition
HIV
By specialty
Infectious disease
By research site
University of Alabama at Birmingham· Birmingham, AL

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