The European Medicines Agency (EMA) has released a draft revision of its guideline on the clinical development of medicines for the treatment of HIV infection, for a six-month public consultation. Comments are being accepted until March 31, 2014.
The proposed revision takes into account developments in HIV treatments that have occurred in the past few years, particularly the use of new, potent antiretroviral agents (ARTs). The guideline outlines a new definition of populations included in clinical trials, moving away from a focus on treatment history to an emphasis on documented viral resistance. Guidance is provided on the development programs and type of data that should be provided for new ARTs.
Source: European Medicines Agency