An open-label trial of stavudine, lamivudine and efavirenz in the treatment of HIV-positive, treatment-naive patients, and implications for clinical practice

A phase II, open-label study of stavudine, lamivudine and efavirenz resulte d in significant reductions in plasma HIV-1 RNA over a 24 week period in hu man immunodeficiency virus (HIV)-infected individuals. The trial currently has 68 patients, and this presentation covers data on the first 42 patients enrolled for 24 weeks. The mean plasma HIV-1 RNA on entry was 75858 HIV RN A copies/ml, and the mean CD4 count was 380 cells/mm(3). After 24 weeks, th e CD4 count increased by 169 cells/mm(3) above baseline. plasma HIV-1 RNA w as markedly reduced: at 24 weeks, more than 97% of patients had <50 HIV RNA copies/ml based on observed data, and 89% of patients had <50 copies/ml ba sed on strict intent-to-treat analysis (non-completer=failure). The favoura ble interactions of these agents resulted in no discontinuations owing to a dverse effects. This regimen provides an important first-line treatment for antiretroviral-naive patients.