Baseline HIV-1 RNA level and CD4 cell count predict time to loss of virologic response to nelfinavir, but not lopinavir/ritonavir, in antiretroviral therapy-naive patients.
Author(s): King MS, Bernstein BM, Walmsley SL, Sherer R, Feinberg J, Sanne I, Cernohous P, Montaner JS, Brun SC, Sun E
Affiliation(s): Abbott Laboratories, Abbott Park, Illinois, USA. email@example.com
Publication date & source: 2004-07-15, J Infect Dis., 190(2):280-4. Epub 2004 Jun 11.
Publication type: Clinical Trial; Clinical Trial, Phase III; Randomized Controlled Trial
Baseline CD4 cell counts and human immunodeficiency virus (HIV)-1 RNA levels have been shown to predict immunologic and virologic responses in HIV-infected patients receiving antiretroviral therapy. In our randomized, double-blind, comparative trial, 653 antiretroviral therapy-naive patients received lopinavir/ritonavir or nelfinavir, plus stavudine and lamivudine, for up to 96 weeks. The risk of loss of virologic response was significantly higher for nelfinavir-treated patients than for lopinavir/ritonavir-treated patients (Cox model hazard ratio, 2.2; 95% confidence interval, 1.7-3.0; P<.001). For nelfinavir-treated patients, but not for lopinavir/ritonavir-treated patients, higher baseline HIV-1 RNA levels and lower baseline CD4 cell counts were associated with a higher risk of loss of virologic response.