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Abstract Details

Activity Number: 572
Type: Contributed
Date/Time: Wednesday, August 1, 2012 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #304891
Title: New Era of HIV Drug Development in a Noninferiority Setting
Author(s): Jing Zhao*+
Companies: Merck Research Laboratories
Address: UG1C-46, North Wales, PA, 19454-1099, United States
Keywords: noninferiority ; antiretroviral therapy ; clinical trial

In 1982 HIV/AIDS caused panic across the world, changing the way many thought about disease and survival. Since then this disease has been spreading at an annual rate of 50 thousand new infections in USA and 2.7 million worldwide. At the end of last century the new combination drugs --- antiretroviral therapy(ART) were found to be highly effective in controlling the deadly disease. Ever since, more and more new developed ARTs have prolonged the lives of HIV patients and transformed HIV/AIDS from an acute disease to a chronic disease. However, there is still an unmet medical need for HIV infected patients to seek novel HIV therapies as more patients are failing current HIV regiments, developing resistance and complications to the drugs. This presentation discusses the new challenges and opportunity for the HIV drug development in the lieu of the current regulatory and economic environment, and also shares a real life experience from a Phase III clinical trial.

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