[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100142489":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":11,"locations":34,"responsibleParty":55,"collaborators":58,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":11,"enrollmentInfo":72,"targetDuration":11,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":82,"overallStatus":86,"whyStopped":11,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Centers for Disease Control and Prevention","FED",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard of Care","ACTIVE_COMPARATOR",null,[13],"Drug: Zidovudine\u002Flamivudine\u002Flopinavir-ritonavir",{"label":15,"type":16,"description":11,"interventionNames":17},"Tenofovir","EXPERIMENTAL",[18],"Drug: Tenofovir\u002Flamivudine\u002Flopinavir-ritonavir",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","Tenofovir\u002Flamivudine\u002Flopinavir-ritonavir","Tenofovir\u002Flamivudine\u002Flopinavir-ritonavir given to mothers starting at 14-28 weeks gestation till labor\u002Fdelivery and continued postpartum if maternal baseline CD4\\\u003C350",[15],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Zidovudine\u002Flamivudine\u002Flopinavir-ritonavir","Zidovudine\u002Flamivudine\u002Flopinavir-ritonavir given to mothers starting at 14-28 weeks gestation till labor\u002Fdelivery and continued postpartum if maternal baseline CD4\\\u003C350",[9],[30],{"name":31,"affiliation":32,"role":33},"Athena P Kourtis, MD, PhD, MPH","Centers for Disease Control and Prevention, Division of Reproductive Health","PRINCIPAL_INVESTIGATOR",[35,47],{"facility":36,"status":11,"city":37,"state":38,"zip":11,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":11},"Liuzhou MCH Hospital","Liuzhou","Guangxi","China","CN",{"type":42,"coordinates":43},"Point",[44,45],109.40698,24.32405,{"lat":45,"lon":44},{"facility":48,"status":11,"city":49,"state":38,"zip":11,"country":39,"countryCode":40,"cosmosGeoPoint":50,"geoPoint":54,"contacts":11},"Guangxi MCH Hospital","Nanning",{"type":42,"coordinates":51},[52,53],108.31667,22.81667,{"lat":53,"lon":52},{"type":33,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Athena Kourtis","Lead Medical Officer",[59],{"name":60,"class":61},"National Center for AIDS\u002FSTD Control and Prevention, China CDC","OTHER_GOV","100142489","phase-2-safety-study-of-a-tenofovir-containing-drug-regimen-for-the-prevention-of-mother-to-child-transmission-of-hiv-and-hbv-100142489",false,"NCT01125696","Safety Study of a Tenofovir-containing Drug Regimen for the Prevention of Mother-to-child Transmission of HIV and HBV","Maternal Tenofovir-containing Combination Drug Regimen During the Second and Third Trimesters of Pregnancy for Prevention of Mother-to-child Transmission of HIV and HBV in HIV-HBV Co-infected Mothers","TiP","Inclusion Criteria:\n\n* Serologically-confirmed HIV and HBV infection\n* Gestational age less than 28 weeks\n* Willingness to participate in a clinical trial\n* Age 20 years or over on the day of inclusion\n* Willingness to return for follow-up visits and to allow infant participation in the trial\n* Intent to remain in the clinic catchment area during the duration of the study\n* No serious current complications of pregnancy\n* No previous or current use of antiretrovirals including the HIVNET 012 regiment\n* Hemoglobin over 8 g\u002FdL\n* Blood creatinine clearance greater than or equal to 60 mL\u002Fmin estimated by the Cockroft-Gault formula for women\n\nExclusion Criteria:\n\n* Age less than 20\n* Pregnant woman refuses to sign the consent to participate\n* Unwillingness to adhere to visit schedule or maintain adherence with medications\n* Illnesses so severe as to likely require maternal hospitalization\n* Intend to breastfeed","FEMALE","20 Years",{"count":73,"type":74},45,"ACTUAL","INTERVENTIONAL",[77],"PHASE2","The purpose of this study is to compare a regimen of tenofovir\u002Flamivudine\u002Flopinavir-ritonavir to the WHO-recommended and locally practiced standard of care regimen consisting of zidovudine\u002Flamivudine\u002Flopinavir-ritonavir during the second and third trimesters of pregnancy in HIV and HBV co-infected women. This is a phase II study evaluating the safety of the test regimen in pregnant women and their newborns. While the study is not powered to examine efficacy, preliminary estimates of transmission of HIV and HBV to the infants and of the rate of resistance development will be obtained.",[80,81],"HIV","Hepatitis B",[83,80,81,84,15,85],"mother-to-child transmission","Pregnant women","Infants","COMPLETED","2020-07-13",{"date":89,"type":74},"2020-07-15",{"date":91,"type":11},"2012-05",{"date":93,"type":74},"2018-08",{"name":5,"class":6},2]