Phase I: clinical pharmacologic studies that look at toxicity and pharmacologic effects. Phase II: clinical investigations of patients for efficacy and relative safety. Phase III: large-scale randomized controlled trials for effectiveness and relative safety, which are often multi-centrered. After a drug passes Phase III testing, it can be licensed for marketing. Phase IV (post-marketing surveillance): monitors new agents as they come into general use by the public.
As compared to placebo, statin therapy reduces noncalcified plaque volume and high risk plaque features in HIV-infected patients with subclinical coronary atherosclerosis. Further studies should assess whether reduction in high risk coronary artery