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HIV clinical trial design for antiretroviral development: moving forward

Drug development for the treatment of HIV infection has proceeded at anunparalleled pace. The collective scientific, industry, and regulatory approach adopted for antiretroviral (ARV) development, including accelerated approval regulations, facilitated expansion from two antiretroviral drug mechanistic classes available prior to 1996, to six drug classes by 2007. Current treatment guidelines emphasize these advances; the goal of ARV therapy in treatmentexperienced patients is the same goal as in treatment-naive patients (HIV-RNA<50 copies/ml) [1–3]. Although the number of approved ARVs is greater than ever before, new and established ARVs for patients with multidrug-resistant virus are still needed.