Efficacy and safety of lopinavir/ritonavir (LPV/r) in antiretroviral-experienced subjects infected with different subtypes of HIV-1

Purpose There are three classes of HIV-1 based on diversity of the viral envelope: M (major), O (outlying) and N (new). The M group is subclassified into nine major subtypes including A—D, F—H, J and K, as well as several recombinant forms. There is a growing need to evaluate antiretroviral (ARV) treatment in these diverse subtypes. Methods M06-802 was an open-label, global, 48-week phase III trial. 599 ARV-experienced, HIV-1-infected subjects were randomized 1:1 to receive LPV/r 800/200mg QD or 400/100mg BID with ≥2 investigator-selected nucleoside/nucleotide reverse transcriptase inhibitors. Classification of HIV-1 viruses by subtype was determined by