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TERMINATED
NCT04500678
PHASE2/PHASE3

Impact of Metformin on Immuno-virologic Parameters in HIV

Sponsor: University of Hawaii

View on ClinicalTrials.gov

Summary

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). 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.

Official title: A 72 Week, Randomized, Open-label vs Observation Study to Assess the Potential Immuno-virologic Benefit of Metformin in HIV-infected Individuals Receiving Antiretroviral Therapy

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

29

Start Date

2019-02-01

Completion Date

2022-12-31

Last Updated

2026-10-20

Healthy Volunteers

No

Conditions

Interventions

DRUG

Metformin

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

Locations (1)

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

Honolulu, Hawaii, United States