This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a pilot study of the safety, efficacy, and tolerability of ezetimibe (ZETIA) in combination with statin therapy for the treatment of elevated LDL cholesterol in HIV-infected subjects. This drug combination has been shown to significantly lower LDL levels in non-HIV-infected individuals, with minimal toxicity. LDL levels are often quite elevated in HIV-infected individuals who are treated with HAART regimens. Their response to statins is often less than what would be expected in non-HIV-infected individuals. Ezetimibe inhibits the intestinal absorption of dietary and biliary cholesterol. It is thought that this drug will have a low likelihood of drug-drug interactions. This will be a crossover study wherein individuals will either receive statin alone or statin plus ezetimibe for 12 weeks, followed by a 4-week washout, and then switched to the alternative regimen for 12 weeks. The primary objectives will be effects on LDL cholesterol and overall safety. Secondary objectives include measurement of total cholesterol, non-HDL cholesterol, HDL cholesterol, triglycerides, C reactive protein, and apolipoprotein B. A total of 43 subjects will allow a 90% chance of detecting a 12% difference in the LDL change. A population of HAART-treated patients will have increased risk of cardiovascular disease as a consequence of their therapy. Lowering LDL would lower that risk.
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