EMA: Concept Paper on the Update of Guidance on the Clinical Development of Medicinal Products for the Treatment of HIV

The present EMA guidance was adopted in 2008. The main circumstance prompting the need for updated guidelines is the changing landscape of HIV treatment following the licensing of new treatment options for treatment experienced patients since 2007 (e.g. darunavir, etravirine, maraviroc and raltegravir).