Prospective, Randomized, Open Label Trial of Efavirenz vs Lopinavir/Ritonavir in HIV+ Treatment-Naive Subjects With CD4+<200 cell/mm3 in Mexico

Objective: To compare the efficacy of efavirenz (EFV) vs lopinavir/ ritonavir (LPV/r) in combination with azidothymidine/lamivudine in antiretroviral therapy naive, HIV+ individuals presenting for care with CD4 + counts 100/mm 3 ). The primary endpoint was the percentage of patients with plasma HIV-1 RNA <50 copies/mL at 48 weeks by intention-to-treat analysis. Results: A total of 189 patients (85% men) were randomized to receive EFV (95) or LPV/r (94). Median baseline CD4 + were 64 and 52/mm 3 , respectively (P = not significant). At week 48, by intention-to-treat analysis, 70% of EFV and 53% of LPV/r patients achieved HIV-1 RNA <50 copies/mL [estimated difference 17% (95% confidence interval 3.5 to 31), P = 0.013]. The proportion with HIV-1 RNA <400 copies/mL was 73% with EFV and 65% with LPV/r(P=0.25). Virologic failure occurred in 7 patients on EFV and 17 on LPV/r. Mean CD4 + count increases (cells/mm 3 ) were 234 for EFV and 239 for LPV/r. Mean change in total cholesterol and triglyceride levels were 50 and 48 mg/dL in EFV and 63 and 116 mg/dL in LPV/r (P = 0.24 and P < 0.01). Conclusions: In these very advanced HIV-infected ARV-naive subjects, EFV-based highly active antiretroviral therapy had superior virologic efficacy than LPV/r-based highly active antiretroviral therapy, with a more favorable lipid profile.