[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100076836":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":26,"locations":26,"responsibleParty":36,"collaborators":26,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":26,"eligibilityCriteria":44,"healthyVolunteers":40,"sex":45,"minAge":46,"maxAge":26,"enrollmentInfo":47,"targetDuration":26,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":58,"whyStopped":26,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":26},{"fullName":5,"class":6},"Tibotec Pharmaceuticals, Ireland","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"001","ACTIVE_COMPARATOR","TMC125 2 x 100 mg tablets b.i.d. \u002F 96 weeks",[13],"Drug: TMC125",{"label":15,"type":16,"description":17,"interventionNames":18},"002","PLACEBO_COMPARATOR","Placebo 2 tablets b.i.d. \u002F 96 weeks",[19],"Drug: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","TMC125","2 x 100 mg tablets b.i.d. \u002F 96 weeks",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo","2 tablets b.i.d. \u002F 96 weeks",[15],[32],{"name":33,"affiliation":34,"role":35},"Tibotec Pharmaceuticals Clinical Trial","Tibotec Pharmaceutical Limited","STUDY_DIRECTOR",{"type":26,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":37,"oldOrganization":34},"Compound Development Team Leader TMC125","100076836","phase-3-tmc125-c216-a-phase-iii-study-to-investigate-the-efficacy-tolerability-and-safety-of-tmc125-as-part-of-an-antiretroviral-regimen-including-tmc114ritonavir-and-an-investigator-selected-optimized-background-in-hiv-1-infected-patients-with-limited-to-no-treatment-options-100076836",false,"NCT00255099","TMC125-C216: A Phase III Study to Investigate the Efficacy, Tolerability and Safety of TMC125 as Part of an Antiretroviral Regimen, Including TMC114\u002FRitonavir and an Investigator-selected Optimized Background, in HIV-1 Infected Patients With Limited to no Treatment Options.","A Phase III Randomized, Double-blinded, Placebo-controlled Trial to Investigate the Efficacy, Tolerability and Safety of TMC125 as Part of an ART Regimen, Including TMC114\u002FRTV and an Investigator-selected OBR, in HIV-1 Infected Patients With Limited Treatment to no Treatment Options.","Inclusion Criteria:\n\n* Patient has 3 or more primary protease inhibitor mutations\n* documented genotypic evidence of resistance to currently available NNRTIs (non-nucleoside reverse transcriptase inhibitors) by having at least 1 NNRTI resistance-associated mutation\n* on a stable antiretroviral therapy for at least 8 weeks\n* plasma viral load at screening visit \\> 5000 HIV-1 RNA copies\u002FmL.\n\nExclusion Criteria:\n\n* Active AIDS defining illnesses (except for stable, cutaneous Kaposi's Sarcoma or wasting syndrome)\n* Any grade 3 or grade 4 toxicity according to the DAIDS grading scale\n* Use of disallowed concurrent therapy\n* Any active clinically significant disease","ALL","18 Years",{"count":48,"type":49},593,"ACTUAL","INTERVENTIONAL",[52],"PHASE3","The purpose of this study is research with the goal of evaluating the effect of TMC125 (a non-nucleoside reverse transcriptase inhibitor) on slowing down the growth of the HIV virus. The study will also investigate whether this new medication is well tolerated, and to further confirm that the medication is safe to be used",[55],"HIV",[55,57,23],"HIV-1","COMPLETED","2011-06-02",{"date":61,"type":62},"2011-06-15","ESTIMATED",{"date":64,"type":26},"2005-12",{"date":66,"type":49},"2008-07",{"name":5,"class":6}]