A randomized trial to study first-line combination therapy with or without a protease inhibitor in HIV-1-infected patients

Remko Van Leeuwen, Christine Katlama, Robert L. Murphy, Kathleen Squires, José Gatell, Andrej Horban, Bonaventura Clotet, Shlomo Staszewski, Arne Van Eeden, Nathan Clumeck, Mauro Moroni, Andrew T. Pavia, Reinhold E. Schmidt, Juan Gonzalez-Lahoz, Julio Montaner, Francisco Antunes, Robert Gulick, Dénes Bánhegyi, Marc Van Der Valk, Peter ReissLiesbeth Van Weert, Frank Van Leth, Victoria A. Johnson, Jean Pierre Sommadossi, Joep M A Lange

Research output: Contribution to journalArticlepeer-review

174 Scopus citations


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 × 106 cells/I 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.

Original languageEnglish (US)
Pages (from-to)987-999
Number of pages13
Issue number7
StatePublished - May 2 2003


  • Atlantic
  • Combination therapy
  • Protease inhibitors

ASJC Scopus subject areas

  • Infectious Diseases
  • Immunology and Allergy
  • Immunology


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