Impact of Metformin on Immuno-virologic Parameters in HIV

Part of paid clinical trials in Honolulu, Hawaii.

Sponsor
University of Hawaii
Study ID
NCT04500678
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Metformin — DRUG
    Metformin 500 mg Extended Release (ER) qd increasing to 1000 mg ER qd at week 4 and continued to week 48.

Study Details

Non-diabetic, aviremic HIV-infected individuals on antiretroviral therapy (ART) will be randomized to metformin therapy or to observation for 72 weeks. Primary objective is to assess change over 72 weeks in CD4 T cell negative checkpoint receptors (PD-1 and TIGIT). As secondary objectives the study will look at 72 week change in other immuno-virologic parameters (CD8 T cell negative checkpoint receptors, plasma indoleamine 2,3-dioxygenase (IDO) levels and CD4 T cell and monocyte intracellular HIV DNA and HIV RNA. The study will also explore the 72 week impact of metformin on change in carotid intima-media thickness (cIMT) as a surrogate marker of atherosclerosis, on neuropsychological (NP) performance, strength, and change in body composition.

Key Dates

First listed
Aug 5, 2020
Start date
Feb 1, 2019
Status verified
Aug 2020
Primary completion
Feb 1, 2022
Completion
Dec 31, 2022

Study Design

Enrollment
38 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Metformin
    Metformin 500 mg Extended Release (ER) qd increasing to 1000 mg ER qd at week 4 and continued to week 48.
  • No Intervention: Observation
    Observed without metformin

Primary Outcome Measure

CD4 T cell PD1+TIGIT+ [ Time Frame: Entry to week 72 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
John A. Burns School of Medicine, University of Hawaii - ManoaHonoluluHawaii96813
Cecilia Shikuma, MD
[email protected]
808-692-1328
Debra Ogata-Arakaki, RN
[email protected]
808 692-1332

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John A. Burns School of Medicine, University of Hawaii - Manoa· Honolulu, HI

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