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 (<or=50 and 51-200 cells/mm(3)) 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 <or=50 cells/mm(3). 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.
Merck Research Laboratories, West Point, PA 19486, USA.
Paul M
PM
Coplan
John R
JR
Cook
George W
GW
Carides
Joseph F
JF
Heyse
Albert W
AW
Wu
Scott M
SM
Hammer
Bach-Yen
BY
Nguyen
Anne R
AR
Meibohm
Mark J
MJ
DiNubile
D000328:Adult; D023241:Antiretroviral Therapy, Highly Active / Q000009:adverse effects / Q000379:methods*; D018791:CD4 Lymphocyte Count; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D017320:HIV Protease Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D019469:Indinavir / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D019259:Lamivudine / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D018894:Reverse Transcriptase Inhibitors / Q000008:administration & dosage; D018434:Sickness Impact Profile; D016019:Survival Analysis; D015215:Zidovudine / Q000008:administration & dosage
D017320:HIV Protease Inhibitors; D018894:Reverse Transcriptase Inhibitors; D019259:Lamivudine; D015215:Zidovudine; D019469:Indinavir