Residual Scope: A5332: Randomized Trial to Prevent Vascular Events in HIV - REPRIEVE

HUMAN CLINICAL TRIAL A Phase 4 Study Evaluating the Effect of Pitavastatin to Prevent Cardiovascular Events in HIV-1 Infected Individuals Short Title: Randomized Trial to Prevent Vascular Events in HIV (the REPREIVE Study) Design: A5332 is a prospective, double-blind, randomized, placebo-controlled phase 4 study of pitavastatin versus placebo for approximately 72 months. Duration: Up to 72 months. Sample size: 6500 subjects. Population: HIV-1 infected men and women age >/=40 and 100 cells/mm3 not meeting 2013 ACC/AHA guideline thresholds for recommended statin initiation. Stratification: CD4+ T-cell counts (500 cells/mm3), sex at birth (male/female), and whether or not a subject has elected to participate in the mechanistic substudy (yes/no). Regimen: At study entry, subjects will be randomized to one of the following arms: ArmA: Pitavastatin 4mg one tablet onc daily taken orally with or without food. Arm B: Pitavastatin placebo one tablet once daily taken orally with or without food.