Impact of indinavir on the quality of life in patients with advanced HIV infection treated with zidovudine and lamivudine.

Objective: In AIDS Clinical Trial Group (ACTG) study 320, triple-combination antiretroviral therapy including indinavir significantly slowed progression to acquired immunodeficiency syndrome or death, compared with treatment with dual nucleoside reverse-transcriptase inhibitors (NRTIs) alone, in zidovudine-experienced patients with advanced human immunodeficiency virus (HIV) infection. We examined the impact of indinavir on quality of life in participants from this study.

Methods: A total of 1156 protease inhibitor- and lamivudine-naive patients stratified by CD4 cell count (
Results: Mean changes in general health scores after 24 weeks were +2.9 in the triple-therapy group versus -0.2 in the dual-therapy group (P=.018). By week 24, scores in all specific domains were higher with triple-drug therapy than dual-drug therapy, with statistically significant differences in role function, energy, and pain scores. Benefits of triple-drug therapy were largely confined to patients with CD4 cell counts of
Conclusions: Triple-drug therapy with indinavir and 2 NRTIs resulted in a significant improvement in general health status after 24 weeks, especially in patients with low CD4 cell counts. Patients receiving triple-drug therapy also had significantly better role function, energy, and pain scores than did patients treated with dual-drug therapy.