title: Prospective, randomized, open label trial of Efavirenz vs Lopinavir/Ritonavir in HIV+ treatment-naive subjects with CD4+<200 cell/mm3 in Mexico.
abstract: 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.
  
  
  METHODS
  Prospective, randomized, open label, multicenter trial in Mexico. HIV-infected subjects with CD4 <200/mm 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 (< or =100 or >100/mm). 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, 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) 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.
authors.affiliation: Department of Infectious Diseases, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City. jsmadero@yahoo.com
authors.forename: Juan
authors.initials: J
authors.lastname: Sierra-Madero
authors.forename: Angelina
authors.initials: A
authors.lastname: Villasis-Keever
authors.forename: Patricia
authors.initials: P
authors.lastname: Méndez
authors.forename: Juan Luis
authors.initials: JL
authors.lastname: Mosqueda-Gómez
authors.forename: Indiana
authors.initials: I
authors.lastname: Torres-Escobar
authors.forename: Fernanda
authors.initials: F
authors.lastname: Gutiérrez-Escolano
authors.forename: Irene
authors.initials: I
authors.lastname: Juárez-Kasusky
authors.forename: Martín
authors.initials: M
authors.lastname: Magana-Aquino
authors.forename: Carmen
authors.initials: C
authors.lastname: Ramos-Santos
authors.forename: Leticia
authors.initials: L
authors.lastname: Pérez-Saleme
authors.forename: Sigfrido
authors.initials: S
authors.lastname: Rangel-Frausto
authors.forename: Barbara
authors.initials: B
authors.lastname: Antuna-Puente
authors.forename: Luis Enrique
authors.initials: LE
authors.lastname: Soto-Ramírez
authors.forename: Vivian
authors.initials: V
authors.lastname: Lima
authors.forename: Franciso
authors.initials: F
authors.lastname: Belaunzarán-Zamudio
authors.forename: Brenda
authors.initials: B
authors.lastname: Crabtree-Ramírez
authors.forename: Julio
authors.initials: J
authors.lastname: Montaner
mesh_terms: D000328:Adult; D000480:Alkynes; D019380:Anti-HIV Agents / Q000008:administration & dosage; D023241:Antiretroviral Therapy, Highly Active / Q000379:methods; D048588:Benzoxazines / Q000008:administration & dosage*; D018791:CD4 Lymphocyte Count; D015496:CD4-Positive T-Lymphocytes / Q000276:immunology / Q000821:virology; D003521:Cyclopropanes; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D015497:HIV-1 / Q000235:genetics / Q000276:immunology*; D006801:Humans; D061466:Lopinavir; D008297:Male; D008800:Mexico; D011446:Prospective Studies; D011744:Pyrimidinones / Q000008:administration & dosage*; D012367:RNA, Viral / Q000097:blood; D019438:Ritonavir / Q000008:administration & dosage*
chemical_list: D000480:Alkynes; D019380:Anti-HIV Agents; D048588:Benzoxazines; D003521:Cyclopropanes; D011744:Pyrimidinones; D012367:RNA, Viral; D061466:Lopinavir; C098320:efavirenz; D019438:Ritonavir