[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100142604":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":25,"locations":40,"responsibleParty":71,"collaborators":73,"id":100,"slug":101,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":25,"eligibilityCriteria":106,"healthyVolunteers":102,"sex":107,"minAge":108,"maxAge":109,"enrollmentInfo":110,"targetDuration":25,"studyType":113,"phases":114,"briefSummary":117,"conditions":118,"keywords":120,"overallStatus":125,"whyStopped":25,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"ANRS, Emerging Infectious Diseases","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"arm 1 (reference strategy)","ACTIVE_COMPARATOR","AZT-3TC-LPV\u002Fr twice a day",[13],"Drug: AZT-3TC-LPV\u002Fr twice a day",{"label":15,"type":16,"description":17,"interventionNames":18},"arm 2 (simplification strategy)","EXPERIMENTAL","ABC-3TC-EFV once a day",[19],"Drug: ABC-3TC-EFV once a day",[21,26],{"type":22,"name":11,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","AZT sirup (10mg\u002Fml): 4 mg\u002Fkg or 180 mg\u002Fm2 twice daily 3TC sirup (10mg\u002Fml): 4 mg\u002Fkg twice daily LPV\u002Fr sirup (80\u002F20 mg\u002Fml): 12 mg\u002Fkg twice daily",[9],null,{"type":22,"name":17,"description":27,"armGroupLabels":28,"otherNames":25},"ABC sirup (20mg\u002Fml): 16 mg\u002Fkg once daily in the morning 3TC sirup (10mg\u002Fml): 8 mg\u002Fkg once daily in the morning EFV sirup (30mg\u002Fml): 25 mg\u002Fkg once daily in the morning before food intake",[15],[30,34,37],{"name":31,"affiliation":32,"role":33},"Marguerite Timite-Konan","Service de pédiatrie - CHU Yopougon - Abidjan, Côte d'Ivoire","PRINCIPAL_INVESTIGATOR",{"name":35,"affiliation":36,"role":33},"Jules Mugabo","Center for Infectious Desease Control - Kigali, Rwanda",{"name":38,"affiliation":39,"role":33},"Nicolas Meda","Université de Ouagadougou - Ouagadougou, Burkina Faso",[41,52,57,66],{"facility":42,"status":25,"city":43,"state":25,"zip":25,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":25},"Service de maladies infectieuses - CHU Charles de Gaulle","Ouagadougou","Burkina Faso","BF",{"type":47,"coordinates":48},"Point",[49,50],-1.53388,12.36566,{"lat":50,"lon":49},{"facility":53,"status":25,"city":43,"state":25,"zip":25,"country":44,"countryCode":45,"cosmosGeoPoint":54,"geoPoint":56,"contacts":25},"Service de pédiatrie - CHU Yalgado Ouedraogo",{"type":47,"coordinates":55},[49,50],{"lat":50,"lon":49},{"facility":58,"status":25,"city":59,"state":25,"zip":25,"country":60,"countryCode":25,"cosmosGeoPoint":61,"geoPoint":65,"contacts":25},"CEPREF","Abidjan","Côte d’Ivoire",{"type":47,"coordinates":62},[63,64],-4.00167,5.35444,{"lat":64,"lon":63},{"facility":67,"status":25,"city":59,"state":25,"zip":25,"country":60,"countryCode":25,"cosmosGeoPoint":68,"geoPoint":70,"contacts":25},"FSU abobo-Avocatier",{"type":47,"coordinates":69},[63,64],{"lat":64,"lon":63},{"type":72,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[74,76,79,82,84,86,88,90,92,94,96,98],{"name":75,"class":6},"European and Developing Countries Clinical Trials Partnership (EDCTP)",{"name":77,"class":78},"Public Research Centre Health, Luxembourg","OTHER",{"name":80,"class":81},"Ministry of Foreign Affairs, Luxembourg","UNKNOWN",{"name":83,"class":78},"University of Ouagadougou, Burkina Faso",{"name":85,"class":78},"Programme PAC-CI, Site ANRS-MIE de Côte d'Ivoire",{"name":87,"class":6},"Ministry of Health, Rwanda",{"name":89,"class":6},"Institut National de la Santé Et de la Recherche Médicale, France",{"name":91,"class":78},"University of Bordeaux",{"name":93,"class":81},"Institut de Sante Publique, d'Epidémiologie et de Développement",{"name":95,"class":78},"Université Montpellier",{"name":97,"class":78},"University of Paris 5 - Rene Descartes",{"name":99,"class":78},"Queen Fabiola Children's University Hospital","100142604","phase-2-evaluation-of-simplified-antiretroviral-treatment-strategies-in-hiv-infected-children-treated-by-antiretroviral-arv-before-one-year-of-age-100142604",false,"NCT01127204","Evaluation of Simplified Antiretroviral Treatment Strategies in HIV Infected Children Treated by Antiretroviral (ARV) Before One Year of Age","Randomized Phase 3 Trial to Evaluate Two Simplified Antiretroviral Treatment Strategies in HIV Infected Children, Treated by Antiretroviral Triple Therapy Before One Year of Age, in Virological Success in Africa (Burkina Faso, Côte d'Ivoire, Rwanda)","Inclusion Criteria for antiretroviral treatment initiation:\n\n* infant follow-up in one of the trial site\n* HIV-1 infection diagnose by RT PCR after 6 weeks of life\n* age between 3 and 12 month at the antiretroviral treatment initiation\n* naive of antiretrovirals except if received for the prevention of mother to child HIV transmission\n* HB\\>=7 g\u002Fdl, neutrophiles\\>750\u002Fmm3, creatinin\\\u003C3xULN, TGO and TGP\\\u003C3xULN\n* signed informed consent\n\nExclusion Criteria for antiretroviral treatment initiation:\n\n* HIV-2 infection or HIV-1\u002FHIV-2 co-infection\n* Known intolerance to one of the trial treatment\n* HB\\\u003C7 g\u002Fdl, neutrophiles\\\u003C750\u002Fmm3, creatinin\\>3xULN, TGO or TGP\\>3xULN\n\nInclusion Criteria for randomisation at 12 months in the simplification phase:\n\n* age 24 months at most\n* virological success define as 2 consecutive indetectable HIV RNA measured by RT PCR at least 3 months apart.\n\nExclusion Criteria for randomisation at 12 months in the simplification phase:\n\n* virological failure after the first 12 months of antiretroviral treatment","ALL","3 Months","12 Months",{"count":111,"type":112},161,"ACTUAL","INTERVENTIONAL",[115,116],"PHASE2","PHASE3","The MONOD trial aim to evaluate the implementation of early antiretroviral treatment strategies in HIV-infected infants and assess the feasibility and efficacy of simplifying the initial proposed regimen after a successful one year treatment. The initial treatment is AZT-3TC-LPV\u002Fr twice a day. After one year, the children will be randomized in one of the following : arm 1-reference AZT-3TC-LPV\u002Fr twice daily; arm 2-simplified ABC-3TC-EFV once daily.\n\nThe perspective of this project is to identify antiretroviral strategies to improve treatment access and adherence for children in sub-saharian Africa.",[119],"HIV Infections",[121,122,123,124],"HIV","Antiretroviral therapy","Infant","Sub Saharian Africa","COMPLETED","2016-07-11",{"date":128,"type":129},"2016-07-12","ESTIMATED",{"date":131,"type":25},"2011-06",{"date":133,"type":112},"2015-04",{"name":5,"class":6},4]