title: A randomized trial to study first-line combination therapy with or without a protease inhibitor in HIV-1-infected patients.
abstract: OBJECTIVE
  To compare one protease inhibitor (PI)-based and two PI-sparing antiretroviral therapy regimens.
  
  
  METHODS
  International, open label, randomized study of antiretroviral drug-naive patients, with CD4 lymphocyte counts >/= 200 x 106 cells/l and plasma HIV-1 RNA levels > 500 copies/ml. Treatment assignment to stavudine and didanosine plus indinavir or nevirapine or lamivudine. Primary study endpoint was the percentage of patients with plasma HIV-1 RNA levels < 500 copies/ml after 48 weeks in the intention-to-treat analysis (ITT).
  
  
  RESULTS
  In total, 298 patients were enrolled. After 48 weeks, the percentage of patients in the indinavir, nevirapine and lamivudine arms with HIV-1 RNA < 500 copies/ml was 57.0%, 58.4% and 58.7%, respectively, in an ITT analysis. After 96 weeks of follow-up, these percentages were 50.0%, 59.6% and 45.0%, respectively. The percentage of patients with HIV-1 RNA < 50 copies/ml was significantly less for those allocated to lamivudine in an on-treatment analysis after 48 and 96 weeks of follow-up. Patients in the nevirapine arm experienced a smaller increase in the absolute number of CD4 T lymphocytes. There were no significant differences in the incidence of serious adverse events.
  
  
  CONCLUSIONS
  A comparable virological response can be achieved with first-line PI-base and PI-sparing regimens. The triple nucleoside regimen utilized may be less likely to result in viral suppression to < 50 copies/ml, while the nevirapine-based regimen is associated with a lower increase in CD4 T lymphocytes.
authors.affiliation: International Antiviral Therapy Evaluation Center, Academic Medical Center, Amsterdam, The Netherlands.
authors.forename: Remko
authors.initials: R
authors.lastname: van Leeuwen
authors.forename: Christine
authors.initials: C
authors.lastname: Katlama
authors.forename: Robert L
authors.initials: RL
authors.lastname: Murphy
authors.forename: Kathleen
authors.initials: K
authors.lastname: Squires
authors.forename: José
authors.initials: J
authors.lastname: Gatell
authors.forename: Andrej
authors.initials: A
authors.lastname: Horban
authors.forename: Bonaventura
authors.initials: B
authors.lastname: Clotet
authors.forename: Shlomo
authors.initials: S
authors.lastname: Staszewski
authors.forename: Arne
authors.initials: A
authors.lastname: van Eeden
authors.forename: Nathan
authors.initials: N
authors.lastname: Clumeck
authors.forename: Mauro
authors.initials: M
authors.lastname: Moroni
authors.forename: Andrew T
authors.initials: AT
authors.lastname: Pavia
authors.forename: Reinhold E
authors.initials: RE
authors.lastname: Schmidt
authors.forename: Juan
authors.initials: J
authors.lastname: Gonzalez-Lahoz
authors.forename: Julio
authors.initials: J
authors.lastname: Montaner
authors.forename: Francisco
authors.initials: F
authors.lastname: Antunes
authors.forename: Robert
authors.initials: R
authors.lastname: Gulick
authors.forename: Dénes
authors.initials: D
authors.lastname: Bánhegyi
authors.forename: Marc
authors.initials: M
authors.lastname: van der Valk
authors.forename: Peter
authors.initials: P
authors.lastname: Reiss
authors.forename: Liesbeth
authors.initials: L
authors.lastname: van Weert
authors.forename: Frank
authors.initials: F
authors.lastname: van Leth
authors.forename: Victoria A
authors.initials: VA
authors.lastname: Johnson
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Sommadossi
authors.forename: Joep M
authors.initials: JM
authors.lastname: Lange
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D023241:Antiretroviral Therapy, Highly Active; D018791:CD4 Lymphocyte Count; D005260:Female; D015658:HIV Infections / Q000097:blood / Q000188:drug therapy*; D017320:HIV Protease Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D015497:HIV-1; D006801:Humans; D019469:Indinavir / Q000009:adverse effects / Q000627:therapeutic use*; D019259:Lamivudine / Q000009:adverse effects / Q000627:therapeutic use*; D008055:Lipids / Q000097:blood; D008297:Male; D008875:Middle Aged; D019829:Nevirapine / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D017320:HIV Protease Inhibitors; D008055:Lipids; D019259:Lamivudine; D019469:Indinavir; D019829:Nevirapine