UCLA, Effect of Pitavastatin on Kidney Function in HIV-infected Persons Sub Study A5332 Kidney Function Ancillary Study

By adding collection of urine and blood longitudinally in at least 2500 participants, this ancillary study will definitively assess whether pitavastatin therapy will prevent significant decline in kidney function and the development of albuminuria (ACR >30 mg/g). This sample will further provide the opportunity to evaluate the effect of pitavastatin in sub-groups of HIV-infected participants for whom the risk of CKD has been demonstrated to be higher, including persons of older age, black race, hypertension, lower CD4 T-cell counts, and on tenofovir-containing regimens. Finally, the mechanisms of action will be assessed to determine whether the protective effect of pitavastatin is mediated through pathways involving inflammation and oxidative stress. Ultimately, the findings of this study will provide longitudinal data on the epidemiology of CKD in the setting of HIV infection, provide mechanistic insights into whether statins prevent CKD by modulating inflammation and oxidative stress, and potentially change guidelines for the prevention of CKD in this at-risk population.