Pregnancy and Infant Outcomes among HIV-Infected Women Taking Long-Term ART with and without Tenofovir in the DART Trial 英文参考文献.docVIP

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Pregnancy and Infant Outcomes among HIV-Infected Women Taking Long-Term ART with and without Tenofovir in the DART Trial 英文参考文献.doc

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Pregnancy and Infant Outcomes among HIV-Infected Women Taking Long-Term ART with and without Tenofovir in the DART Trial 英文参考文献

PregnancyandInfantOutcomesamongHIV-Infected WomenTakingLong-TermARTwithandwithout TenofovirintheDARTTrial DianaM.Gibb1*,HildaKizito2,ElizabethC.Russell1,EnnieChidziva3,EvaZalwango4,RuthNalumenya5, MoiraSpyer1,DinahTumukunde2,KusumNathoo6,PaulaMunderi4,HopeKyomugisha2,JamesHakim3, HeinerGrosskurth4,CharlesF.Gilks7,A.SarahWalker1.,PhillipaMusoke8.,onbehalfoftheDARTtrial team 1MRCClinical Trials Unit, London,United Kingdom, 2JointClinical ResearchCentre,Kampala,Uganda,3University ofZimbabwe Clinical ResearchCentre,College of HealthSciences,Harare,Zimbabwe,4MRC/UVRIUgandaResearchUnitonAIDS,Entebbe,Uganda,5InfectiousDiseasesInstitute,MakerereUniversity,Mulago,Uganda, 6UniversityofZimbabweMedicalSchool,DepartmentofPaediatricsandChildHealth,Harare,Zimbabwe,7ImperialCollege,London,UnitedKingdom,8Departmentof PaediatricsandChildHealth,CollegeofHealthSciences,MakerereUniversity,Uganda Abstract Background: Few data have described long-term outcomes for infants born to HIV-infected African women taking antiretroviral therapy (ART) in pregnancy. This is particularly true for World Health Organization (WHO)–recommended tenofovir-containingfirst-lineregimens,whichareincreasinglyusedandknowntocauserenalandbonetoxicities;concerns havebeenraisedaboutpotentialtoxicityinbabiesduetoinuterotenofovirexposure. MethodsandFindings:Pregnancyoutcomeandmaternal/infantARTwerecollectedinUgandan/ZimbabweanHIV-infected women initiating ART during The Development of AntiRetroviral Therapy in Africa (DART) trial, which compared routine laboratory monitoring (CD4; toxicity) versus clinically driven monitoring. Women were followed 15 January 2003 to 28 September2009.Infantfeeding,clinicalstatus,andbiochemistry/haematologyresultswerecollectedinaseparateinfant study. Effect of in utero ART exposure on infant growth was analysed using random effects models. 382 pregnancies occurredin302/1,867(16%)women(4.4/100woman-years[95%CI4.0–4.9]).226/390(58%)outcomeswerelive-births,27 (7%) stillbirths ($22wk),