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J Infect Dis. 2008 Apr 15;197(8):1133-44. doi: 10.1086/586713.

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

Collaborators (750)

Gordin F, Finley E, Dietz D, Chesson C, Vjecha M, Standridge B, Schmetter B, Grue L, Willoughby M, Demers A, Lundgren JD, Phillips A, Dragsted UB, Jensen KB, Fau A, Borup L, Pearson M, Jansson PO, Jensen BG, Benfield TL, Darbyshire JH, Babiker AG, Palfreeman AJ, Fleck SL, Collaco-Moraes Y, Cordwell B, Dodds W, van Hooff F, Wyzydrag L, Cooper DA, Drummond FM, Connor A, Satchell CS, Gunn S, Oka S, Delfino MA, Merlin K, McGinley C, Neaton JD, Bartsch G, DuChene A, George M, Grund B, Harrison M, Hogan C, Krum E, Larson G, Miller C, Nelson R, Neuhaus J, Roediger MP, Schultz T, Thackeray L, Prineas R, Campbell C, Perez G, Lifson A, Duprez D, Hoy J, Lahart C, Perlman D, Price R, Prineas R, Rhame F, Sampson J, Worley J, Rein M, DerSimonian R, Brody BA, Daar ES, Dubler NN, Fleming TR, Freeman DJ, Kahn JP, Kim KM, Medoff G, Modlin JF, Moellering R Jr, Murray BE, Pick B, Robb ML, Scharfstein DO, Sugarman J, Tsiatis A, Tuazon C, Zoloth L, Klingman K, Lehrman S, Lazovski J, Belloso WH, Losso MH, Benetucci JA, Aquilia S, Bittar V, Bogdanowicz EP, Cahn PE, Casiró AD, Cassetti I, Contarelli JM, Corral JA, Crinejo A, Daciuk L, David DO, Guaragna G, Ishida MT, Krolewiecki A, Laplume HE, Lasala MB, Lourtau L, Lupo SH, Maranzana A, Masciottra F, Michaan M, Ruggieri L, Salazar E, Sánchez M, Somenzini C, Hoy JF, Rogers GD, Allworth AM, Anderson JS, Armishaw J, Barnes K, Carr A, Chiam A, Chuah JC, Curry MC, Dever RL, Donohue WA, Doong NC, Dwyer DE, Dyer J, Eu B, Ferguson VW, French MA, Garsia RJ, Gold J, Hudson JH, Jeganathan S, Konecny P, Leung J, McCormack CL, McMurchie M, Medland N, Moore RJ, Moussa MB, Orth D, Piper M, Read T, Roney JJ, Roth N, Shaw DR, Silvers J, Smith DJ, Street AC, Vale RJ, Wendt NA, Wood H, Youds DW, Zillman J, Rieger A, Tozeau V, Aichelburg A, Vetter N, Clumeck N, Dewit S, de Roo A, Kabeya K, Leonard P, Lynen L, Moutschen M, O'Doherty E, Pereira C Jr, Souza TN, Schechter M, Zajdenverg R, Almeida MM, Araujo F, Bahia F, Brites C, Caseiro MM, Casseb J, Etzel A, Falco GG, Filho EC, Flint SR, Gonzales CR, Madruga JV, Passos LN, Reuter T, Sidi LC, Toscano AL, Zarowny D, Cherban E, Cohen J, Conway B, Dufour C, Ellis M, Foster A, Haase D, Haldane H, Houde M, Kato C, Klein M, Lessard B, Martel A, Martel C, McFarland N, Paradis E, Piche A, Sandre R, Schlech W, Schmidt S, Smaill F, Thompson B, Trottier S, Vezina S, Walmsley S, Wolff Reyes MJ, Northland R, Ostergaard L, Pedersen C, Nielsen H, Hergens L, Loftheim IR, Jensen KB, Raukas M, Zilmer K, Justinen J, Ristola M, Girard PM, Landman R, Abel S, Abgrall S, Amat K, Auperin L, Barruet R, Benalycherif A, Benammar N, Bensalem M, Bentata M, Besnier JM, Blanc M, Bouchaud O, Cabié A, Chavannet P, Chennebault JM, Dargere S, de la Tribonniere X, Debord T, Decaux N, Delgado J, Dupon M, Durant J, Frixon-Marin V, Genet C, Gérard L, Gilquin J, Hoen B, Jeantils V, Kouadio H, Leclercq P, Lelièvre JD, Levy Y, Michon CP, Nau P, Pacanowski J, Piketty C, Poizot-Martin I, Raymond I, Salmon D, Schmit JL, Serini MA, Simon A, Tassi S, Touam F, Verdon R, Weinbreck P, Weiss L, Yazdanpanah Y, Yeni P, Fätkenheuer G, Staszewski S, Bergmann F, Bitsch S, Bogner JR, Brockmeyer N, Esser S, Goebel FD, Hartmann M, Klinker H, Lehmann C, Lennemann T, Plettenberg A, Potthof A, Rockstroh J, Ross B, Stoehr A, Wasmuth JC, Wiedemeyer K, Winzer R, Hatzakis A, Touloumi G, Antoniadou A, Daikos GL, Dimitrakaki A, Gargalianos-Kakolyris P, Giannaris M, Karafoulidou A, Katsambas A, Katsarou O, Kontos AN, Kordossis T, Lazanas MK, Panagopoulos P, Panos G, Paparizos V, Papastamopoulos V, Petrikkos G, Sambatakou H, Skoutelis A, Tsogas N, Xylomenos G, Bergin CJ, Mooka B, Pollack S, Mamorksy MG, Agmon-Levin N, Karplus R, Kedem E, Maayan S, Shahar E, Sthoeger Z, Turner D, Yust I, Tambussi G, Rusconi V, Abeli C, Bechi M, Biglino A, Bonora S, Butini L, Carosi G, Casari S, Corpolongo A, De Gioanni M, Di Perri G, Di Pietro M, D'Offizi G, Esposito R, Mazzotta F, Montroni M, Nardini G, Nozza S, Quirino T, Raise E, Honda M, Ishisaka M, Caplinskas S, Uzdaviniene V, Schmit JC, Staub T, Himmich H, Marhoum El Filali K, Mills GD, Blackmore T, Masters JA, Morgan J, Pithie A, Brunn J, Ormassen V, La Rosa A, Guerra O, Espichan M, Gutierrez L, Mendo F, Salazar R, Knytz B, Horban A, Bakowska E, Beniowski M, Gasiorowski J, Kwiatkowski J, Antunes F, Castro RS, Doroana M, Horta A, Mansinho K, Miranda AC, Pinto IV, Valadas E, Vera J, Rakhmanova A, Vinogradova E, Yakovlev A, Zakharova N, Wood R, Orrel C, Gatell J, Arnaiz JA, Carrillo R, Clotet B, Dalmau D, González A, Jordano Q, Jou A, Knobel H, Larrousse M, Mata R, Moreno JS, Oretaga E, Pena JN, Pulido F, Rubio R, Sanz J, Viciana P, Hirschel B, Spycher R, Battegay M, Bernasconi E, Bottone S, Cavassini M, Christen A, Franc C, Furrer HJ, Gayet-Ageron A, Genné D, Hochstrasser S, Magenta L, Moens C, Müller N, Nüesch R, Phanuphak P, Ruxrungtham K, Pumpradit W, Chetchotisakd P, Dangthongdee S, Kiertiburanakul S, Klinbuayaem V, Mootsikapun P, Nonenoy S, Piyavong B, Prasithsirikul W, Raksakulkarn P, Gazzard BG, Ainsworth JG, Anderson J, Angus BJ, Barber TJ, Brook MG, Care CD, Chadwick DR, Chikohora M, Churchill DR, Cornforth D, Dockrell DH, Easterbrook PJ, Fox PA, Fox R, Gomez PA, Gompels MM, Harris GM, Herman S, Jackson AG, Jebakumar SP, Johnson MA, Kinghorn GR, Kuldanek KA, Larbalestier N, Leen C, Lumsden M, Maher T, Mantell J, Maw R, McKernan S, McLean L, Morris S, Muromba L, Orkin CM, Palfreeman AJ, Peters BS, Peto TE, Portsmouth SD, Rajamanoharan S, Ronan A, Schwenk A, Slinn MA, Stroud CJ, Thomas RC, Wansbrough-Jones MH, Whiles HJ, White DJ, Williams E, Williams IG, Youle M, Abrams I, Acosta EA, Adams S, Adamski A, Andrews L, Antoniskis D, Aragon DR, Arduino R, Artz R, Bailowitz J, Barnett BJ, Baroni C, Barron M, Baxter JD, Beers D, Beilke M, Bemenderfer D, Bernard A, Besch CL, Bessesen MT, Bethel JT, Blue S, Blum JD, Boarden S, Bolan RK, Borgman JB, Brar I, Braxton BK, Bredeek UF, Brennan R, Britt DE, Brockelman J, Brown S, Bruzzese V, Bulgin-Coleman D, Bullock DE, Cafaro V, Campbell B, Caras S, Carroll J, Casey KK, Chiang F, Childress G, Cindrich RB, Clark C, Climo M, Cohen C, Coley J, Condoluci DV, Contreras R, Corser J, Cozzolino J, Crane LR, Daley L, Dandridge D, D'Antuono V, Darcourt Rizo Patron JG, DeHovitz JA, DeJesus E, DesJardin J, Diaz-Linares M, Dietrich C, Dodson P, Dolce E, Elliott K, Erickson D, Estes M, Faber LL, Falbo J, Farrough MJ, Farthing CF, Ferrell-Gonzalez P, Flynn H, Frank C, Frank M, Freeman K, French N, Friedland G, Fujita N, Gahagan L, Genther K, Gilson I, Goetz MB, Goodwin E, Graziano F, Guity CK, Gulick P, Gunderson ER, Hale CM, Hannah K, Henderson H, Hennessey K, Henry WK, Higgins DT, Hodder SL, Horowitz HW, Howe-Pittman M, Hubbard J, Hudson R, Hunter H, Hutelmyer C, Insignares MT, Jackson L, Jenny L, John M, Johnson DL, Johnson G, Johnson J, Johnson L, Kaatz J, Kaczmarski J, Kagan S, Kantor C, Kempner T, Kieckhaus K, Kimmel N, Klaus BM, Klimas N, Koeppe JR, Koirala J, Kopka J, Kostman JR, Kozal MJ, Kumar A, Labriola A, Lampiris H, Lamprecht C, Lattanzi KM, Lee J, Leggett J, Long C, Loquere A, Loveless K, Lucasti CJ, Luskin-Hawk R, MacVeigh M, Makohon LH, Mannheimer S, Markowitz NP, Marks C, Martinez N, Martorell C, McFeaters E, McGee B, McIntyre DM, McKee J, McManus E, Melecio LG, Melton D, Mercado S, Merrifield E, Mieras JA, Mogyoros M, Moran FM, Murphy K, Mushatt D, Mutic S, Nadeem I, Nadler JP, Nahass R, Nixon D, O'Brien S, Ognjan A, O'Hearn M, O'Keefe K, Okhuysen PC, Oldfield E, Olson D, Orenstein R, Ortiz R, Osterberger J, Owen W, Parpart F, Pastore-Lange V, Paul S, Pavlatos A, Pearce DD, Pelz R, Perez G, Peterson S, Pierone G Jr, Pitrak D, Powers SL, Pujet HC, Raaum JW, Ravishankar J, Reeder J, Regevik N, Reilly NA, Reyelt C, Riddell J 4th, Rimland D, Robinson ML, Rodriguez AE, Rodriguez-Barradas MC, Rodriguez Derouen V, Roland R, Rosmarin C, Rossen WL, Rouff JR, Sampson JH, Sands M, Savini C, Schrader S, Schulte MM, Scott C, Scott R, Seedhom H, Sension M, Sheble-Hall A, Sheridan A, Shuter J, Slater LN, Slotten R, Slowinski D, Smith M, Snap S, States DM, Stewart M, Stringer G, Sullivan J, Summers KK, Swanson K, Sweeton IB, Szabo S, Tedaldi EM, Telzak EE, Temesgen Z, Thomas D, Thompson MA, Thompson S, Ting Hong Bong C, Tobin C, Uy J, Vaccaro A, Vasco LM, Vecino I, Verlinghieri GK, Visnegarwala F, Wade BH, Watson V, Weis SE, Weise JA, Weissman S, Wilkin AM, Williams L, Witter JH, Wojtusic L, Wright TJ, Yeh V, Young B, Zeana C, Zeh J, Savio E, Vacarezza M.

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.

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).

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 ).

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.

PMID:
18476292
[PubMed - indexed for MEDLINE]
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