Prospective, Randomized, Open Label Trial of Efavirenz vs Lopinavir/Ritonavir in HIV plus 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 < 200/mm(3). Methods: Prospective, randomized, open label, multicenter trial in Mexico. HIV-infected subjects with CD4 <200/mm(3) were randomized to receive open label EFV or LPV/r plus azidothymidine/lamivudine (fixed-dose combination) for 48 weeks. Randomization was stratified by baseline CD4(+) cell count (<= 100 or >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.