University of Hawaii
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.
Inclusion Criteria: * HIV+ * On suppressive ART stable for \> 1 year * Plasma HIV RNA \< 50 copies/mL within 3 months of entry, with no HIV RNA \> 200 copies/mL within the past 6 months prior to entry * Age \>40 years * Ability and willingness to provide written informed consent Exclusion Criteria: * Uncontrolled chronic medical condition or cancer * Acute illness within 2 weeks of entry * Diagnosis of diabetes by history, fasting blood glucose \>126, or by HgbA1c \> 6.5 * Chronic, uncontrolled diarrhea * Known hypersensitivity or contraindication to metformin use * Current presence of hepa…
Metformin 500 mg Extended Release (ER) qd increasing to 1000 mg ER qd at week 4 and continued to week 48.
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