Once a new therapeutic agent or strategy has been thoroughly studied in preclinical studies, the information generated typically is submitted to the Food and Drug Administration (FDA) as part of an Investigational New Drug (IND) application. Evaluation of the therapeutic agent or strategy in human subjects can begin once FDA has approved the IND application.
Clinical trials commonly are designed to investigate the safety and efficacy of new therapeutic agents for the treatment of HIV and its co-infections. Studies also are conducted to evaluate strategies for the best use of these therapeutic agents in combination with other agents, including how to minimize drug-related complications. With the advent of highly active antiretroviral therapy (HAART), the complications associated with HIV infection have expanded to include changes in metabolism caused both by HIV disease and the use of antiretroviral agents. These metabolic changes include altered body fat distribution or lipodystrophy, insulin resistance, elevated triglyceride and cholesterol levels, bone demineralization, and elevated lactate levels. The underlying pathogenic mechanisms of these changes are unknown or poorly understood, and the long-term consequences, including increased risk of cardiovascular disease, are under investigation.
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Last Updated April 20, 2008