Back to Search
Start Over
Major clinical outcomes in antiretroviral therapy (ART)-naive participants and in those not receiving ART at baseline in the SMART study.
- Source :
-
The Journal of infectious diseases [J Infect Dis] 2008 Apr 15; Vol. 197 (8), pp. 1133-44. - Publication Year :
- 2008
-
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.<br />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).<br />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=.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 ).<br />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. These findings require validation in a large, randomized clinical trial.
- Subjects :
- AIDS-Related Opportunistic Infections immunology
AIDS-Related Opportunistic Infections mortality
Adult
CD4 Lymphocyte Count
Cohort Studies
Drug Administration Schedule
Female
HIV Infections immunology
HIV Infections mortality
HIV Infections virology
Humans
Kaplan-Meier Estimate
Male
Middle Aged
Treatment Outcome
Anti-HIV Agents administration & dosage
HIV immunology
HIV Infections drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 0022-1899
- Volume :
- 197
- Issue :
- 8
- Database :
- MEDLINE
- Journal :
- The Journal of infectious diseases
- Publication Type :
- Academic Journal
- Accession number :
- 18476292
- Full Text :
- https://doi.org/10.1086/586713