EMA Rethinks HIV Trial Cohort in Light of Improved Treatments

The European Medicines Agency says HIV-infected patients recruited for clinical trials should be assessed based on their documented viral resistance, rather than treatment history, as viral resistance has become rarer with the introduction of newer and better drugs in the past few years. In the third update of its guideline on clinical development of drugs to treat HIV, the agency says clinical trials should take into account that new potent antiretroviral agents have greatly improved the ability of physicians to treat HIV.
International Pharmaceutical Regulatory Monitor