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

Paul M. Coplan, John R. Cook, George W. Carides, Joseph F. Heyse, Albert W. Wu, Scott M. Hammer, Bach Yen Nguyen, Anne R. Meibohm, Mark J. DiNubile

Research output: Contribution to journalArticlepeer-review

16 Scopus citations


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 (≤50 and 51-200 cells/mm3) were randomized to receive zidovudine (or stavudine) and lamivudine, with or without indinavir. Health-related quality of life was measured using the ACTG QoL601-602 questionnaire, which assesses general health status measured on a visual analogue scale and 8 specific health-related domains. Quality-adjusted survival time was estimated using the visual analogue scale for general health. 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 ≤550 cells/mm3. Quality-adjusted survival time did not differ significantly between the 2 treatment groups. 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.

Original languageEnglish (US)
Pages (from-to)426-433
Number of pages8
JournalClinical Infectious Diseases
Issue number3
StatePublished - Aug 1 2004

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases


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