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Randomized Controlled Trial
. 2008 Apr 15;197(8):1133-44.
doi: 10.1086/586713.

VSports - Major clinical outcomes in antiretroviral therapy (ART)-naive participants and in those not receiving ART at baseline in the SMART study

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Randomized Controlled Trial

"V体育2025版" Major clinical outcomes in antiretroviral therapy (ART)-naive participants and in those not receiving ART at baseline in the SMART study

Strategies for Management of Antiretroviral Therapy (SMART) Study Group et al. J Infect Dis. .

Abstract

Background: The SMART study randomized 5,472 human immunodeficiency virus (HIV)-infected patients with CD4+ cell counts >350 cells/microL to intermittent antiretroviral therapy (ART; the drug conservation [DC] group) versus continuous ART (the viral suppression [VS] group). In the DC group, participants started ART when the CD4+ cell count was <250 cells/microL. Clinical outcomes in participants not receiving ART at entry inform the early use of ART VSports手机版. .

Methods: Patients who were either ART naive (n=249) or who had not been receiving ART for >or= 6 months (n=228) were analyzed. The following clinical outcomes were assessed: (i) opportunistic disease (OD) or death from any cause (OD/death); (ii) OD (fatal or nonfatal); (iii) serious non-AIDS events (cardiovascular, renal, and hepatic disease plus non-AIDS-defining cancers) and non-OD deaths; and (iv) the composite of outcomes (ii) and (iii). V体育安卓版.

Results: A total of 477 participants (228 in the DC group and 249 in the VS group) were followed (mean, 18 months). For outcome (iv), 21 and 6 events occurred in the DC (7 in ART-naive participants and 14 in those who had not received ART for >or= 6 months) and VS (2 in ART-naive participants and 4 in those who had not received ART for 6 months) groups, respectively. Hazard ratios for DC vs. VS by outcome category were as follows: outcome (i), 3. 47 (95% confidence interval [CI], 1. 26-9. 56; p=. 02); outcome (ii), 3. 26 (95% CI, 1. 04-10. 25; p= V体育ios版. 04); outcome (iii), 7. 02 (95% CI, 1. 57-31. 38; p=. 01); and outcome (iv), 4. 19 (95% CI, 1. 69-10. 39; p=. 002 ). .

Conclusions: Initiation of ART at CD4+ cell counts >350 cells/microL compared with <250 cells/microL may reduce both OD and serious non-AIDS events VSports最新版本. These findings require validation in a large, randomized clinical trial. .

Trial registration: ClinicalTrials. gov NCT00027352 V体育平台登录. .

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