Impact of Metformin on Immuno-virologic Parameters in HIV
Status:
Recruiting
Trial end date:
2022-12-31
Target enrollment:
Participant gender:
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). 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.