Effects of Intermittent IL-2 Alone or with Peri-Cycle Antiretroviral Therapy in Early HIV Infection The STALWART Study 英文参考文献.docVIP

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Effects of Intermittent IL-2 Alone or with Peri-Cycle Antiretroviral Therapy in Early HIV Infection The STALWART Study 英文参考文献.doc

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Effects of Intermittent IL-2 Alone or with Peri-Cycle Antiretroviral Therapy in Early HIV Infection The STALWART Study 英文参考文献

EffectsofIntermittentIL-2AloneorwithPeri-Cycle AntiretroviralTherapyinEarlyHIVInfection:The STALWARTStudy JorgeA.Tavel*,INSIGHTSTALWARTStudyGroup NationalInstituteofAllergyandInfectiousDiseases,NationalInstitutesofHealth,Bethesda,Maryland,UnitedStatesofAmerica Abstract Background:TheStudyofAldesleukinwithandwithoutantiretroviraltherapy(STALWART)evaluatedwhetherintermittent interleukin-2 (IL-2) alone or with antiretroviral therapy (ART) around IL-2 cycles increased CD4 counts compared to no therapy. + Methodology:ParticipantsnotoncontinuousARTwith$300CD4+cells/mm3wererandomizedto:notreatment;IL-2for5 consecutivedaysevery8weeksfor3cycles;orthesameIL-2regimenwith10daysofARTadministeredaroundeachIL-2 cycle.CD4 counts,HIVRNA,andHIVprogressioneventswerecollectedmonthly. + PrincipalFindings:Atotalof267participantswererandomized.Atweek32,themeanCD4+countwas134cellsgreaterin theIL-2alonegroup(p,0.001),and133cellsgreaterintheIL-2plusARTgroup(p,0.001)comparedtothenotherapy group.TwelveparticipantsintheIL-2groupscomparedto1participantinthegroupassignedtonotherapyexperiencedan opportunisticeventordied(HR5.84,CI:0.59to43.57;p=0.009). Conclusions: IL-2 alone or with peri-cycle HAART increases CD4+ counts but was associated with a greater number of opportunisticeventsordeathscomparedtonotherapy.Theseresultscallintoquestiontheimmunoprotectivesignificance ofIL-2-inducedCD4 cells. + TrialRegistration:ClinicalTNCCitation:TavelJA,INSIGHTSTALWARTStudyGroup(2010)EffectsofIntermittentIL-2AloneorwithPeri-CycleAntiretroviralTherapyinEarlyHIVInfection:The STALWARTStudy.PLoSONE5(2):e9334.doi:10.1371/journal.pone.0009334 Editor:EsperGeorgesKallas,UniversityofSaoPaulo,Brazil ReceivedSeptember21,2009;AcceptedJanuary8,2010;PublishedFebruary23,2010 Thisisanopen-accessarticledistributedunderthetermsoftheCreativeCommonsPublicDomaindeclarationwhichstipulatesthat,onceplacedinthepublic domain,thisworkmaybefreelyreproduced,distributed,transmitted,modified,builtupon,orotherwiseusedbyanyonefo