A PILOT STUDY OF THE SAFETY, EFFICACY, AND TOLERABILITY OF EZETIMIBE (ZETIA?)

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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. A5209 is a double-blind, randomized, placebo-controlled, crossover study designed to determine the safety, efficacy, and tolerability of ezetimibe (Zetia) therapy in combination with ongoing statin therapy in HIV-infected subjects with elevated LDL cholesterol. HIV-infected men and women > 18 years of age on highly active antiretroviral therapy (HAART) and statin therapy for at least 3 months prior to study entry and on stable statin and HAART for at least 30 days prior to study entry and with elevated low-density lipoprotein cholesterol (LDL-c) >130 mg/dL will be enrolled. A total of 43 subjects will have 9 study visits over a 28- week period. Subjects will receive ezetimibe 10 mg by mouth once daily for 12 weeks. Study evaluations include history and physical exams, laboratory testing, and questionnaires.