PHASE I/II STUDIES OF INVESTIGATIONAL AMINOQUINOLINES

$0M01FY2000RRNIH

Tulane University Of Louisiana, New Orleans LA

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Abstract

There is an urgent need for well-designed, prospective studies to elucidate the incidence, time of onset, pathophysiology, predictors, and clinical significance of metabolic complications associated with HIV infection and/or its treatment. Therefore, the primary objective of this protocol is to compare changes in total cholesterol, triglycerides, waist circumference, and waist-to-hip ratio from baseline to 1 year post-randomization among the three randomized HAART strategies in FIRST. The secondary objectives of this study are: 1) to compare changes over time in total cholesterol, triglycerides, waist circumference, and waist-to-hip ratio over time among the three randomized HAART strategies in the FIRST protocol; 2) to compare changes in body composition/habitus indicators; 3) to determine the association between changes in lipids and changes in the measurements; 4) to compare the use of cardiovascular agents and antidiabetic agents; 5) to compare survival and the incidence of angina pectoris, myocardial infarction, stroke, and diabetes mellitus.

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