Health-related quality of life in HIV-infected naive patients treated with nelfinavir or nevirapine associated with ZDV/3TC (the COMBINE-QoL substudy)

A. Casado, Xavier Badia*, E. Consiglio, E. Ferrer, A. González, E. Pedrol, J. M. Gatell, C. Azuaje, J. M. Llibre, M. Aranda, P. Barrufet, J. Martínez-Lacasa, D. Podzamczer, M. J. Barberá, M. Santín, H. Knobel, R. Solé, J. M. Miró, L. Lozano, E. RiberaI. Ocaña, M. Roget, D. Dalmau

*Corresponding author for this work

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16 Citations (Scopus)

Abstract

Purpose: The aim of the study was to assess differences in health-related quality of life (HRQoL) in HIV-infected naive patients treated with two HAART regimens at 12 months. Method: The MOS-HIV questionnaire was used to measure HRQoL in a subgroup of 127 patients included in the COMBINE study, which was an open-label, randomized, multicenter study comparing zidovudine (ZDV) and lamivudine (3TC) plus nelfinavir (NFV) or nevirapine (NVP) regimens in HIV-infected naive patients. 63 patients were included in the ZDV/3TC/NFV arm and 64 in the ZDV/3TC/NVP arm. Results: No statistically significant differences were observed at baseline in demographic and clinical variables and HRQoL scores between treatment groups, except that the proportion of homosexual men was higher in the ZDV/3TC/NVP arm. There were no statistically significant differences in HRQoL scores between arms at 12 months and over time; only ZDV/3TC/NVP patients showed statistically significant improvement in Physical Health Summary score (p < .01) and a trend toward a better profile in Mental Health Summary score (p = .07). Overall, patients who were treated with ZDV/3TC/NVP showed greater changes in physical dimensions and patients who were treated with ZDV/3TC/NFV showed greater changes in mental health. Conclusion: Differences in HRQoL between study groups at 1 year follow-up were not detected. Nevertheless, a trend toward improvement was observed in summary health scores in ZDV/3TC/NVP-treated patients.

Original languageAmerican English
Pages (from-to)132-139
Number of pages8
JournalHIV Clinical Trials
Volume5
Issue number3
DOIs
Publication statusPublished - May 2004

Keywords

  • Health-related quality of life
  • HIV-infected naive patients
  • Nelfinavir
  • Nevirapine

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