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

ConditionsSystemic InflammationImmune DysregulationInjection Drug UseHIV
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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/Vaccine

    All participants will take a Jynneos (MPOX) vaccine.

  • Capvaxvie

    Biological/Vaccine

    All participants will take a Capvaxvie (PCV21, pneumococcal) vaccine.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Metformin GroupExperimental treatment 3 interventions
Group B: Placebo GroupPlacebo comparator 3 interventions

Trial outcomes

Primary outcomes

1

Change in Serum C-reactive Protein (CRP)

Assessed by Enzyme Linked Immunosorbent Assay (ELISA) of blood samples collected at baseline and at 16 weeks. Reported in mg/dL.

Time frame
Baseline to Week 16

Secondary outcomes

1

Change in exhausted B cells

Assessed by flow cytometry of blood samples collected at baseline and at 16 weeks. Reported as percentage of total B cells.

Time frame
Baseline to Week 16
2

Change in exhausted T cells

Assessed by flow cytometry of blood samples collected at baseline and at 16 weeks. Reported as percentage of total T cells.

Time frame
Baseline to Week 16
3

Change in MPOX vaccine-specific IgG antibody.

Assessed by Enzyme Linked Immunosorbent Assay (ELISA) of blood samples collected at baseline and at 13 weeks. Reported as micrograms/mL.

Time frame
Baseline to Week 13
4

Change in PCV21 vaccine-specific IgG antibody.

Assessed by Enzyme Linked Immunosorbent Assay (ELISA) of blood samples collected at baseline and at 9 weeks. Reported as micrograms/mL.

Time frame
Baseline to Week 9

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alabama at Birmingham

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov
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