[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100097791":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":20,"locations":20,"responsibleParty":25,"collaborators":28,"id":31,"slug":32,"hasResults":33,"nctId":34,"briefTitle":35,"officialTitle":36,"acronym":20,"eligibilityCriteria":37,"healthyVolunteers":38,"sex":39,"minAge":40,"maxAge":20,"enrollmentInfo":41,"targetDuration":20,"studyType":44,"phases":45,"briefSummary":47,"conditions":48,"keywords":50,"overallStatus":62,"whyStopped":20,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":20},{"fullName":5,"class":6},"Tibotec, Inc","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"001","EXPERIMENTAL","TMC125; darunavir; ritonavirTMC125 400mg once daily for 4 weeks; Darunavir-800mg once daily for 48 weeks; Ritonavir-100mg once daily for 48 weeks",[13],"Drug: TMC125; darunavir; ritonavir",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","TMC125; darunavir; ritonavir","TMC125 400mg once daily for 4 weeks; Darunavir-800mg once daily for 48 weeks; Ritonavir-100mg once daily for 48 weeks",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Tibotec, Inc. Clinical Trial","STUDY_DIRECTOR",{"type":20,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":26,"oldOrganization":27},"Vice President Clinical Affairs","Tibotec Therapeutics Clinical Affairs, a Division of Ortho Biotech Clinical Affairs, LLC",[29],{"name":30,"class":6},"Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA","100097791","phase-2-a-study-to-evaluate-the-pharmacokinetic-profile-how-the-body-absorbs-distributes-metabolizes-and-eliminates-a-drug-of-tmc125-plus-tenofoviremtricitabine-once-daily-with-or-without-darunavirr-once-daily-in-antiretroviral-arv-naive-hiv-1-patients-patients-have-never-received-arv-treatment-100097791",true,"NCT00534352","A Study to Evaluate the Pharmacokinetic Profile (How the Body Absorbs, Distributes, Metabolizes and Eliminates a Drug) of TMC125 Plus Tenofovir\u002FEmtricitabine Once Daily With or Without Darunavir\u002Fr Once Daily in Antiretroviral (ARV) Naive HIV-1 Patients (Patients Have Never Received ARV Treatment).","A Multicenter Study to Evaluate the Pharmacokinetic Profile and Safety of TMC125 Plus Tenofovir DF\u002FEmtricitabine All Dosed Once Daily With and Without Darunavir (PREZISTA™)\u002F Ritonavir Once Daily in Antiretroviral naïve HIV-1 Infected Subjects","Inclusion Criteria:\n\n* Documented HIV-1 infection\n* Naive to antiretroviral therapy (never received antiretroviral therapy prior to study)\n* In the opinion of the investigator, have an indication for antiretroviral therapy\n* Able to comply with the protocol requirements\n\nExclusion Criteria:\n\n* No previous or current use of antiretroviral medications (ARVs) for the treatment of HIV infection or hepatitis B\u002FC infection with anti-HIV activity\n* No evidence of antiretroviral resistance on current or past resistance assays\n* No chronic hepatitis B and\u002For C co-infection\n* No grade 3 or 4 laboratory abnormality as defined by National Institute of Allergy and Infectious Diseases Division of Acquired Immunodeficiency Syndrome (DAIDS) grading tables, or a calculated creatinine clearance (CLCr) \\\u003C 50 mL\u002Fmin.\n* No known diabetes mellitus or hyperlipidemia requiring lipid-lowering therapy\n* No acute viral hepatitis including, but not limited to A, B, or C.",false,"ALL","18 Years",{"count":42,"type":43},23,"ACTUAL","INTERVENTIONAL",[46],"PHASE2","The purpose of this study is to determine the pharmacokinetic profile of TMC125 400mg with tenofovir DF\u002Femtricitabine FDC (fixed dose combination) 300\u002F200mg all dosed once daily with and without darunavir\u002Fritonavir 800\u002F100 mg once daily in HIV-1 infected, antiretroviral (ARV) naÃ-ve patients (patients who have never received ARV treatment).",[49],"HIV-1 Infection",[51,52,53,54,55,56,57,58,59,60,61],"HIV","AIDS","Immunodeficiency Virus, Human","PREZISTA","darunavir","TMC114","TMC125","Protease Inhibitor","Non-Nucleoside Reverse Transcriptase Inhibitor","Truvada","Treatment Naive","COMPLETED","2015-03-26",{"date":65,"type":66},"2015-04-16","ESTIMATED",{"date":68,"type":20},"2008-01",{"date":70,"type":43},"2009-03",{"name":5,"class":6}]