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.
A randomized trial to study first-line combination therapy with or without a protease inhibitor in HIV-1-infected patients / R. van Leeuwen, C. Katlama, R.L. Murphy, K. Squires, J. Gatell, A. Horban, B. Clotet, S. Staszewski, A. van Eeden, N. Clumeck, M. Moroni, A.T. Pavia, R.E. Schmidt, J. Gonzalez-Lahoz, J. Montaner, F. Antunes, R. Gulick, D. Banhegyi, M. van der Valk, P. Reiss, L. van Weert, F. van Leth, V.A. Johnson, J.P. Sommadossi, J.M. Lange. - In: AIDS. - ISSN 0269-9370. - 17:7(2003), pp. 987-999.
A randomized trial to study first-line combination therapy with or without a protease inhibitor in HIV-1-infected patients
M. Moroni;
2003
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 × 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.
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