The effect of nevirapine in combination with nelfinavir in heavily pretreated HIV-1-infected patients - A prospective, open-label, controlled, randomized study

The purpose of the current study was to determine the efficacy and safety o f nevirapine combined with nelfinavir and two nucleoside reverse transcript ase inhibitors (NRTIs) in patients previously exposed to highly active anti retroviral therapy (HAART). In a prospective, open-label, randomized study, 56 HIV-infected adults who had received HAART, including saquinavir hard g el capsule, ritonavir, or indinavir, were randomly assigned to receive nevi rapine in addition to nelfinavir and two NRTIs. The proportion of patients who achieved an undetectable viral load (plasma HIV-RNA < 200 copies/ml) at weeks 24 and 36 was significantly higher in the nevirapine group than in t he control group (55% and 52% vs. 22% and 22%; p = .015 and p = .047). No d ifferences in CD4 cell count or clinical outcome were observed. In the nevi rapine group, 17% of patients discontinued treatment because of rashes. We conclude that the addition of nevirapine, when switching from one protease inhibitor-containing regimen to one containing nelfinavir, has a substantia l effect on viral suppression.