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 <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.
Sierra-Madero
Juan
J
Department of Infectious Diseases, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City. jsmadero@yahoo.com
Villasis-Keever
Angelina
A
Méndez
Patricia
P
Mosqueda-Gómez
Juan Luis
JL
Torres-Escobar
Indiana
I
Gutiérrez-Escolano
Fernanda
F
Juárez-Kasusky
Irene
I
Magana-Aquino
Martín
M
Ramos-Santos
Carmen
C
Pérez-Saleme
Leticia
L
Rangel-Frausto
Sigfrido
S
Antuna-Puente
Barbara
B
Soto-Ramírez
Luis Enrique
LE
Lima
Vivian
V
Belaunzarán-Zamudio
Franciso
F
Crabtree-Ramírez
Brenda
B
Montaner
Julio
J
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*
D000480:Alkynes; D019380:Anti-HIV Agents; D048588:Benzoxazines; D003521:Cyclopropanes; D011744:Pyrimidinones; D012367:RNA, Viral; D061466:Lopinavir; C098320:efavirenz; D019438:Ritonavir