EFFECT OF COMBTHERW/FISH OIL SUPP&FENOFIBRATE ON TG LEVELS IN SBJCTS ON HAART

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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. A5186 is a phase II, randomized, open-label, multi-site trial to determine the efficacy and safety of fish oil combined with fenofibrate in HIV-infected subjects on highly active antiretroviral therapy (HAART) with elevated serum triglycerides (TG) who are not responding to either agent alone. Potential study subjects are HIV-infected men and women 18 years of age and older, who have been on stable HAART for the previous 3 months and do not plan to change their HAART regimen for the 22 weeks of the study, with fasting lipid abnormalities (low-density lipoprotein [LDL] =160 mg/dL and TG ¿ 400 mg/dL), and with plasma HIV-1 RNA =10,000 copies/mL. Subjects should remain on their current individual HAART regimen for the duration of the study. HAART medications will not be supplied by the study. Study treatment will be provided through week 18. There will be a maximum of two steps in this study: Step 1 - At study entry, subjects will be randomized to one of the following arms: Arm A: Fish oil supplement 3 gm PO BID Arm B: Fenofibrate 160 mg PO QD Response to study treatment is defined as fasting serum triglycerides < 200 mg/dL at week 8. Subjects who are responding at week 8 will remain on single agent therapy through week 18. Subjects who are not responding at week 8 will register to Step 2 at week 10. Step 2 At week 10, subjects who have not responded to single agent therapy will begin combined therapy of fenofibrate and fish oil and remain on combined therapy through week 18.