biostudies-literatureDaar ESNCATS NIH HHSNCRR NIH HHSNIAID NIH HHS445-56https://www.ebi.ac.uk/biostudies/studies/S-EPMC3430716biostudies-literatureUnknown154(7)<h4>Background</h4>Limited data compare once-daily options for initial therapy for HIV-1.<h4>Objective</h4>To compare time to virologic failure; first grade-3 or -4 sign, symptom, or laboratory abnormality (safety); and change or discontinuation of regimen (tolerability) for atazanavir plus ritonavir with efavirenz-containing initial therapy for HIV-1.<h4>Design</h4>A randomized equivalence trial accrued from September 2005 to November 2007, with median follow-up of 138 weeks. Regimens were assigned by using a central computer, stratified by screening HIV-1 RNA level less than 100 000 copies/mL or 100 000 copies/mL or greater; blinding was known only to the site pharmacist. (ClinicalTrials.gov registration number: NCT00118898)<h4>Setting</h4>59 AIDS Clinical Trials Group sites in the UniteAnnals of internal medicineAtazanavir plus ritonavir or efavirenz as part of a 3-drug regimen for initial treatment of HIV-1.PMC3430716UL1 RR024160U01 AI068636-055U01 AI069484-02AI069424AI27661RR024996U01 AI069484U01 AI038858R01 AI058740-09AI032782AI27666UL1 RR025747-04U01 AI038855U01 AI046376-05S4U01 AI025868-181UL1 RR025777-01N01 AI72626U01 AI069452-03RR00046UL1 RR025008UL1 RR024156UO1 AI025859AI069439UM1 AI069511UM1 AI069477P30 AI073961U01 AI046370-05AI069434UL1 TR000124U01 AI0694955U01 AI069428U01 AI069494U01 AI069472-05U01 AI069472-01U01 AI069472-035U01 AI069470-03AI69501AI69465U01 AI069419R01 AI058740U01 AI069418UL1 RR025777U01 AI069532-05P30 AI045008U01 AI069423-05U01 AI069532U01 AI069415AI348533U01 AI046376 05S4P30 AI027757AI58740UL1 TR000454RR0257475U01 AI0694185U01 AI069415-035P30 AI045008-10U01 AI069419-05AI25868U01 AI069428-05U01 AI027666-181U01 AI069494-01U01 AI069501U01 AI069467P30 AI073961-05U01 AI069447-03U01 AI069439-05U01 AI069471U01 AI069470AI069532U01 AI069472U01 AI046370U01 AI069495-05U01 AI032782U01 AI069470-03AI069495U01 AI069470-05UL1 RR024160-05U01 AI032782-13U01 AI069513-05U01 AI025859-18U01 AI025859U01 AI069474U01 AI046376U01 AI069477U01 AI069467-01U01 AI069484-02U01 AI069467-03U01 AI069511U01 AI069513AI069501UM1 AI0686341UL1 RR024156U01 AI038858-05U01 AI069471-055U01 AI069470U01 AI034853U01 AI069494-015U01 AI069471AI073961AI69419U01 AI068636UL1 RR024996U01 AI025868U01 AI068634AI46370U01 AI0694471UO1 AI069494-01AI069513U54 RR023561U01 AI027658AI069477AI069474AI069472AI0694711U01 AI069502-01AI69423U01 AI027661-19U01 AI027661-18U01 AI027658-18U01 AI069511-06UL1 RR025777-011U01 AI069472-01AI504101U01 AI69467-01U01 AI069452U01AI068636P30 AI050410AI38858U01 AI068634-05U01 AI069501-05U01 AI027666U01 AI069415-03AI38855P30 AI045008-10U01 AI069428AI69556AI69432UL1 RR025747U01 AI069424-05U01 AI034853-12U01 AI069556-05UL1 RR024156-05U01 AI069424U01 AI069423U01 AI027661P30 AI050410-145U01 AI069447U01 AI069418-05AI27675M01 RR000046-41U01 AI069474-05P30 AI050409U01 AI069477-05U01 AI069439U01 AI069432-05AI68634M01 RR000046U01 AI069432U01 AI069556RR025780UL1 RR024996-05Patterson HRay GPatterson KSmith KYMeier JLPollard RBHughes VGripshover BLane TWBalfour HHPfister SJahed NCYin MTHughes SRagan DGoldman MThal GSaemann MJames TMarrero SPahwa SJarocki BDunaway SBMollan KBenson CAJain MEpperson KBoyce CLoquere AMoe ASwindells SOBrien WASax PEDescallar RChelsea CDemeter LMiller MThomas ACorales RZadzilka ALopez RHurley CAlbrecht MEl Sadr WCollier ACCamp RSantana JLVan Meter FEl-Daher NBurgett-Yandow NRevuelta MShore JNorris JOlusanya AKatzenstein DLindsey EDavis CECasey GMcMahon DTimpone JKalayjian RBolivar HAdams BTaiwo BUkwu MCheng ARutecki BMong-Kryspin LSilberman MBoston MKoletar SLMegill CSwiatek JARooney JFPittard DAdams MCurrin DStapleton JTZimmerman EWiggins IColon LFeinberg JSkolnik PRHenry KLuetkemeyer AHsaio CBWulfsohn MAshton CBudhathoki CFarajallah AHammer SMKumar PMaffei KAntosh DFox KAWoodward WCMildvan DBloom ABischofberger NDaar ESMyers LMartinez APollard RCox GMRobbins GGochnour DTashima KTRodriguez MDeaconess BIFischl MAShaik Sdel Rio CGeiseler JFunk CAYoumans AJohnson SLennox JJohnson TMorse GAIDS Clinical Trials Group Study A5202 TeamRogers LPappa KAJackson BHa BDelaney JWhitely KShulman NReisler RVasquez MMorse GDGross RDaskalakis DTierney CNavarro SSmith KGodfrey CSeefried EValle SStorey SSGothing JReid JKim GYPayne MPalmer MPetersen THoffman JHMorgan MBordenave BfalseAtazanavir plus ritonavir or efavirenz as part of a 3-drug regimen for initial treatment of HIV-1.<h4>Background</h4>Limited data compare once-daily options for initial therapy for HIV-1.<h4>Objective</h4>To compare time to virologic failure; first grade-3 or -4 sign, symptom, or laboratory abnormality (safety); and change or discontinuation of regimen (tolerability) for atazanavir plus ritonavir with efavirenz-containing initial therapy for HIV-1.<h4>Design</h4>A randomized equivalence trial accrued from September 2005 to November 2007, with median follow-up of 138 weeks. Regimens were assigned by using a central computer, stratified by screening HIV-1 RNA level less than 100 000 copies/mL or 100 000 copies/mL or greater; blinding was known only to the site pharmacist. (ClinicalTrials.gov registration number: NCT00118898)<h4>Setting</h4>59 AIDS Clinical Trials Group sites in the Unite2011-01-01T00:00:00Z2011 Apr2025-04-04T14:42:43.087Z2019-03-27T00:57:18ZS-EPMC34307162132092310.1059/0003-4819-154-7-201104050-0031610.7326/0003-4819-154-7-201104050-00316