[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100219226":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":44,"centralContacts":28,"locations":28,"responsibleParty":48,"collaborators":28,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":58,"sex":59,"minAge":60,"maxAge":28,"enrollmentInfo":61,"targetDuration":28,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":28,"overallStatus":70,"whyStopped":28,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":28},{"fullName":5,"class":6},"Merck Sharp & Dohme LLC","INDUSTRY",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Reformulated Raltegravir","EXPERIMENTAL","Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks",[13,14,15],"Drug: Reformulated Raltegravir","Drug: TRUVADA™","Drug: Placebo to Raltegravir",{"label":17,"type":18,"description":19,"interventionNames":20},"Raltegravir","ACTIVE_COMPARATOR","Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks",[21,14,22],"Drug: Raltegravir","Drug: Placebo to Reformulated Raltegravir",[24,29,32,36,40],{"type":25,"name":9,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily",[9],null,{"type":25,"name":17,"description":30,"armGroupLabels":31,"otherNames":28},"Raltegravir 400 mg tablet orally twice daily",[17],{"type":25,"name":33,"description":34,"armGroupLabels":35,"otherNames":28},"TRUVADA™","Emtricitabine \u002F tenofovir disoproxil fumarate 200 \u002F 300 mg tablet administered once-daily with food (open-label)",[17,9],{"type":25,"name":37,"description":38,"armGroupLabels":39,"otherNames":28},"Placebo to Reformulated Raltegravir","Placebo to reformulated raltegravir 2 tablets orally once daily",[17],{"type":25,"name":41,"description":42,"armGroupLabels":43,"otherNames":28},"Placebo to Raltegravir","Placebo to raltegravir 1 tablet orally twice daily",[9],[45],{"name":46,"affiliation":5,"role":47},"Medical Director","STUDY_DIRECTOR",{"type":49,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100219226","phase-3-evaluation-of-the-safety-and-efficacy-of-reformulated-raltegravir-mk-0518-1200-mg-once-daily-in-combination-with-truvada-in-human-immunodeficiency-virus-hiv-1-infected-treatment-naive-participants-mk-0518-292-100219226",true,"NCT02131233","Evaluation of the Safety and Efficacy of Reformulated Raltegravir (MK-0518) 1200 mg Once Daily in Combination With TRUVADA™ in Human Immunodeficiency Virus (HIV)-1 Infected, Treatment-Naive Participants (MK-0518-292)","A Phase III Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Reformulated Raltegravir 1200 mg Once Daily Versus Raltegravir 400 mg Twice Daily, Each in Combination With TRUVADA™, in Treatment-Naïve HIV-1 Infected Subjects","onceMRK","Inclusion Criteria:\n\n* HIV-1 positive\n* Naïve to antiretroviral therapy including investigational antiretroviral agents\n* Not of reproductive potential or, if of reproductive potential agrees to 1) true abstinence, or 2) use of an acceptable method of birth control during the study\n\nExclusion Criteria:\n\n* Use of recreational or illicit drugs or has recent history of drug or alcohol abuse or dependence\n* Has been treated for a viral infection other than HIV-1 (such as hepatitis B) with an agent that is active against HIV-1 including but not limited to adefovir, tenofovir, entecavir, emtricitabine, or lamivudine\n* Has documented or known resistance to raltegravir, emtricitabine, and\u002For tenofovir before the first dose of study drug\n* Has participated in a study with an investigational compound or device within 30 days or anticipates participating in such a study during this study\n* Has used systemic immunosuppressive therapy or immune modulators within 30 days or is anticipated to need them during the study (short courses of corticosteroids are allowed)\n* Requires or is anticipated to require any of the following prohibited medications while in the study: phenobarbital, phenytoin, rifampin, rifabutin, or calcium, magnesium and aluminum containing antacids, such as TUMS™, Maalox™ and Milk of Magnesia™\n* Has significant hypersensitivity or other contraindication to any of the components of the study drugs\n* Has current, active diagnosis of acute hepatitis due to any cause\n* Is pregnant, breastfeeding, or expecting to conceive during the study\n* Female participant expecting to donate eggs or male participant expecting to donate sperm during the study\n* Is or has a family member (spouse or children) who is investigational staff or sponsor staff directly involved in this trial",false,"ALL","18 Years",{"count":62,"type":63},802,"ACTUAL","INTERVENTIONAL",[66],"PHASE3","To evaluate the safety and efficacy of reformulated raltegravir (MK-0518) 1200 mg once daily in combination with TRUVADA™ versus raltegravir 400 mg twice daily in combination with TRUVADA™ in HIV-1 infected, treatment-naive participants. The primary hypothesis being tested is that reformulated raltegravir 1200 mg once-daily is non-inferior to raltegravir 400 mg twice-daily, each in combination therapy with TRUVADA™, as assessed by the proportion of participants achieving HIV-1 ribonucleic acid (RNA) \\\u003C40 copies\u002FmL at Week 48.",[69],"HIV Infection","COMPLETED","2019-01-11",{"date":73,"type":63},"2019-01-30",{"date":75,"type":63},"2014-05-23",{"date":77,"type":63},"2016-12-19",{"name":5,"class":6}]