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

The Strategies for Management of Antiretroviral Therapy (SMART) Study Group

Research output: Contribution to journalArticle

305 Citations (Scopus)

Abstract

Background. The SMART study randomized 5472 human immunodeficiency virus (HIV)-infected patients with CD4+ cell counts >350 cells/μL to intermittent antiretroviral therapy (ART; the drug conservation [DC] group) versus continuous ART (the viral supression [VS] group). In the DC group, participants started ART when the CD4+ cell count was <250 cells/μL. Clinical outcomes in participants not receiving ART at entry inform the early use of ART. Methods. Patients who were either ART naive (n = 249) or who had not been receiving ART for ≤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). 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 ≤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). Conclusions. Initiation of ART at CD4+ cell counts >350 cells/μL compared with <250 cells/μL may reduce both OD and serious non-AIDS events. These findings require validation in a large, randomized clinical trial. Trial registration. ClinicalTrials.gov identifier: NCT00027352.

Original languageEnglish (US)
Pages (from-to)1133-1144
Number of pages12
JournalJournal of Infectious Diseases
Volume197
Issue number8
DOIs
StatePublished - Apr 15 2008
Externally publishedYes

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CD4 Lymphocyte Count
Therapeutics
Randomized Controlled Trials
HIV
Drug Therapy
Pharmaceutical Preparations

ASJC Scopus subject areas

  • Immunology and Allergy
  • Infectious Diseases

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Major clinical outcomes in antiretroviral therapy (ART)-naive participants and in those not receiving ART at baseline in the SMART Study. / The Strategies for Management of Antiretroviral Therapy (SMART) Study Group.

In: Journal of Infectious Diseases, Vol. 197, No. 8, 15.04.2008, p. 1133-1144.

Research output: Contribution to journalArticle

The Strategies for Management of Antiretroviral Therapy (SMART) Study Group. / Major clinical outcomes in antiretroviral therapy (ART)-naive participants and in those not receiving ART at baseline in the SMART Study. In: Journal of Infectious Diseases. 2008 ; Vol. 197, No. 8. pp. 1133-1144.
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title = "Major clinical outcomes in antiretroviral therapy (ART)-naive participants and in those not receiving ART at baseline in the SMART Study",
abstract = "Background. The SMART study randomized 5472 human immunodeficiency virus (HIV)-infected patients with CD4+ cell counts >350 cells/μL to intermittent antiretroviral therapy (ART; the drug conservation [DC] group) versus continuous ART (the viral supression [VS] group). In the DC group, participants started ART when the CD4+ cell count was <250 cells/μL. Clinical outcomes in participants not receiving ART at entry inform the early use of ART. Methods. Patients who were either ART naive (n = 249) or who had not been receiving ART for ≤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). 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 ≤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). Conclusions. Initiation of ART at CD4+ cell counts >350 cells/μL compared with <250 cells/μL may reduce both OD and serious non-AIDS events. These findings require validation in a large, randomized clinical trial. Trial registration. ClinicalTrials.gov identifier: NCT00027352.",
author = "{The Strategies for Management of Antiretroviral Therapy (SMART) Study Group} and Sean Emery and Neuhaus, {Jacqueline A.} and Phillips, {Andrew N.} and Abdel Babiker and Cohen, {Calvin J.} and Gatell, {Jose M.} and Girard, {Pierre Marie} and Birgit Grund and Matthew Law and Losso, {Marcelo H.} and Adrian Palfreeman and Robin Wood and F. Gordin and E. Finley and D. Dietz and C. Chesson and M. Vjecha and B. Standridge and B. Schmetter and L. Grue and M. Willoughby and A. Demers and Lundgren, {J. D.} and A. Phillips and Dragsted, {U. B.} and Jensen, {K. B.} and A. Fau and L. Borup and M. Pearson and Jansson, {P. O.} and Jensen, {B. G.} and Benfield, {T. L.} and Darbyshire, {J. H.} and Babiker, {A. G.} and Palfreeman, {A. J.} and Fleck, {S. L.} and Y. Collaco-Moraes and B. Cordwell and W. Dodds and {van Hooff}, F. and L. Wyzydrag and Cooper, {D. A.} and Drummond, {F. M.} and Connor, {S. A.} and Satchell, {C. S.} and S. Gunn and S. Oka and Delfino, {M. A.} and K. Merlin and Rodriguez, {Allan E}",
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TY - JOUR

T1 - Major clinical outcomes in antiretroviral therapy (ART)-naive participants and in those not receiving ART at baseline in the SMART Study

AU - The Strategies for Management of Antiretroviral Therapy (SMART) Study Group

AU - Emery, Sean

AU - Neuhaus, Jacqueline A.

AU - Phillips, Andrew N.

AU - Babiker, Abdel

AU - Cohen, Calvin J.

AU - Gatell, Jose M.

AU - Girard, Pierre Marie

AU - Grund, Birgit

AU - Law, Matthew

AU - Losso, Marcelo H.

AU - Palfreeman, Adrian

AU - Wood, Robin

AU - Gordin, F.

AU - Finley, E.

AU - Dietz, D.

AU - Chesson, C.

AU - Vjecha, M.

AU - Standridge, B.

AU - Schmetter, B.

AU - Grue, L.

AU - Willoughby, M.

AU - Demers, A.

AU - Lundgren, J. D.

AU - Phillips, A.

AU - Dragsted, U. B.

AU - Jensen, K. B.

AU - Fau, A.

AU - Borup, L.

AU - Pearson, M.

AU - Jansson, P. O.

AU - Jensen, B. G.

AU - Benfield, T. L.

AU - Darbyshire, J. H.

AU - Babiker, A. G.

AU - Palfreeman, A. J.

AU - Fleck, S. L.

AU - Collaco-Moraes, Y.

AU - Cordwell, B.

AU - Dodds, W.

AU - van Hooff, F.

AU - Wyzydrag, L.

AU - Cooper, D. A.

AU - Drummond, F. M.

AU - Connor, S. A.

AU - Satchell, C. S.

AU - Gunn, S.

AU - Oka, S.

AU - Delfino, M. A.

AU - Merlin, K.

AU - Rodriguez, Allan E

PY - 2008/4/15

Y1 - 2008/4/15

N2 - Background. The SMART study randomized 5472 human immunodeficiency virus (HIV)-infected patients with CD4+ cell counts >350 cells/μL to intermittent antiretroviral therapy (ART; the drug conservation [DC] group) versus continuous ART (the viral supression [VS] group). In the DC group, participants started ART when the CD4+ cell count was <250 cells/μL. Clinical outcomes in participants not receiving ART at entry inform the early use of ART. Methods. Patients who were either ART naive (n = 249) or who had not been receiving ART for ≤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). 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 ≤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). Conclusions. Initiation of ART at CD4+ cell counts >350 cells/μL compared with <250 cells/μL may reduce both OD and serious non-AIDS events. These findings require validation in a large, randomized clinical trial. Trial registration. ClinicalTrials.gov identifier: NCT00027352.

AB - Background. The SMART study randomized 5472 human immunodeficiency virus (HIV)-infected patients with CD4+ cell counts >350 cells/μL to intermittent antiretroviral therapy (ART; the drug conservation [DC] group) versus continuous ART (the viral supression [VS] group). In the DC group, participants started ART when the CD4+ cell count was <250 cells/μL. Clinical outcomes in participants not receiving ART at entry inform the early use of ART. Methods. Patients who were either ART naive (n = 249) or who had not been receiving ART for ≤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). 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 ≤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). Conclusions. Initiation of ART at CD4+ cell counts >350 cells/μL compared with <250 cells/μL may reduce both OD and serious non-AIDS events. These findings require validation in a large, randomized clinical trial. Trial registration. ClinicalTrials.gov identifier: NCT00027352.

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U2 - 10.1086/586713

DO - 10.1086/586713

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VL - 197

SP - 1133

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JO - Journal of Infectious Diseases

JF - Journal of Infectious Diseases

SN - 0022-1899

IS - 8

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