[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100218110":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":66,"centralContacts":33,"locations":33,"responsibleParty":70,"collaborators":33,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":80,"sex":81,"minAge":82,"maxAge":33,"enrollmentInfo":83,"targetDuration":33,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":33,"overallStatus":92,"whyStopped":93,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":33},{"fullName":5,"class":6},"Merck Sharp & Dohme LLC","INDUSTRY",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Raltegravir plus Nevirapine plus Lamivudine","EXPERIMENTAL","Raltegravir 400 mg oral twice daily for 96 weeks; plus nevirapine 200 mg oral once daily for 14 days followed by nevirapine 200 mg oral twice daily, plus lamivudine 150 mg oral twice daily for 96 weeks",[13,14,15],"Drug: Raltegravir (MK-0518)","Drug: Nevirapine","Drug: Lamivudine",{"label":17,"type":18,"description":19,"interventionNames":20},"Protease Inhibitor\u002FRitonavir plus tenofovir\u002Femtricitabine","ACTIVE_COMPARATOR","Tenofovir\u002Femtricitabine 300\u002F200 mg oral once daily plus 1) lopinavir\u002Fritonavir 400\u002F100 mg oral twice daily or 800\u002F200 mg oral once daily, or 2) atazanavir\u002Fritonavir 300\u002F100 mg oral once daily, or 3) darunavir\u002Fritonavir 800\u002F100 mg oral once daily or 600\u002F100 mg oral twice daily",[21,22,23,24,25,26],"Drug: Tenofovir","Drug: Emtricitabine","Drug: Lopinavir","Drug: Ritonavir","Drug: Atazanavir","Drug: Darunavir",[28,34,38,42,46,50,54,58,62],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","Raltegravir (MK-0518)","Raltegravir (MK-0518) 400 mg tablets",[9],null,{"type":29,"name":35,"description":36,"armGroupLabels":37,"otherNames":33},"Nevirapine","Nevirapine (NVP) 200 mg tablets",[9],{"type":29,"name":39,"description":40,"armGroupLabels":41,"otherNames":33},"Lamivudine","Lamivudine (3TC) 150 mg tablets",[9],{"type":29,"name":43,"description":44,"armGroupLabels":45,"otherNames":33},"Tenofovir","Tenofovir disoproxil fumarate (TDF) 300 mg tablets",[17],{"type":29,"name":47,"description":48,"armGroupLabels":49,"otherNames":33},"Emtricitabine","Emtricitabine (FTC) 200 mg tablets",[17],{"type":29,"name":51,"description":52,"armGroupLabels":53,"otherNames":33},"Lopinavir","Lopinavir (LPV) 200 mg tablets",[17],{"type":29,"name":55,"description":56,"armGroupLabels":57,"otherNames":33},"Ritonavir","Ritonavir (r) 100 mg tablets",[17],{"type":29,"name":59,"description":60,"armGroupLabels":61,"otherNames":33},"Atazanavir","Atazanavir (ATV) 300 mg tablets",[17],{"type":29,"name":63,"description":64,"armGroupLabels":65,"otherNames":33},"Darunavir","Darunavir (DAR) 400 mg tablets",[17],[67],{"name":68,"affiliation":5,"role":69},"Medical Director","STUDY_DIRECTOR",{"type":71,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100218110","phase-2-evaluation-of-renal-function-efficacy-and-safety-when-switching-from-tenofoviremtricitabine-plus-a-protease-inhibitorritonavir-to-a-combination-of-raltegravir-mk-0518-plus-nevirapine-plus-lamivudine-in-hiv-1-participants-with-suppressed-viremia-and-impaired-renal-function-mk-0518-284-100218110",true,"NCT02116660","Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir\u002FEmtricitabine Plus a Protease Inhibitor\u002FRitonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284)","Switching From Regimens Consisting of a RTV-Boosted Protease Inhibitor Plus TDF\u002FFTC to a Combination of Raltegravir Plus Nevirapine and Lamivudine in HIV Patients With Suppressed Viremia and Impaired Renal Function (RANIA Study) (Pilot Study) Protocol MK-0518-284-03","RANIA","Inclusion Criteria:\n\n* Male, or non-pregnant, non-breastfeeding female\n* No previous history of virological failure\n* No previous exposure to non-nucleoside reverse transcriptase inhibitors or integrase inhibitors\n* No previous history of intolerance to lamivudine\n* At least 2 documented plasma HIV-1 RNA \\\u003C50 copies\u002FmL and no HIV-1 \\>50 copies\u002FmL in the 12 months before screening\n* Receiving the same protease inhibitor\u002Fritonavir plus tenofovir\u002Femtricitabine combination for at least the 6 months before screening\n* Has no major International Antiviral Society (IAS)-USA mutations on genotype testing performed before starting antiretroviral treatment\n* Sexually-active participants and their partners of child-bearing potential agree to use a medically acceptable method of contraception from 2 weeks before Day 1 and for at least 6 months after the last dose of study drug (postmenopausal women are not required to use contraception; sexually-active male participants with a female partner of child-bearing potential must provide written informed consent to information regarding any pregnancy)\n\nExclusion Criteria:\n\n* Positive for hepatitis B surface antigen (HBsAg+) or anticipated need for hepatitis C virus treatment\n* Liver cirrhosis\n* Has a history of diabetes mellitus, defined as initiation of antidiabetic treatment or verification of diabetes in a case report form\n* Has any cancer, excluding stable Kaposi Sarcoma\n* Allergy or sensitivity to the investigational product or excipients\n* Female participant who is nursing\n* Female participant who is pregnant or intends to become pregnant\n* Has an active Acquired Immunodeficiency Syndrome (AIDS)-defining event except stable Kaposi Sarcoma or HIV Wasting Syndrome\n* Received any investigational drug within 30 days before screening\n* Participated in any other clinical trial within 30 days before signing informed consent for the current trial",false,"ALL","18 Years",{"count":84,"type":85},11,"ACTUAL","INTERVENTIONAL",[88],"PHASE2","To evaluate changes in renal function, efficacy, and safety when switching from a combination of tenofovir\u002Femtricitabine (TDF\u002FFTC) plus a protease inhibitor\u002Fritonavir (PI\u002Fr) to a combination of raltegravir (MK-0518) plus nevirapine plus lamivudine in human immunodeficiency virus (HIV)-1 infected participants with suppressed viremia and impaired renal function.",[91],"HIV Infections","TERMINATED","This study was terminated early due to poor recruitment.","2019-04-05",{"date":96,"type":85},"2019-04-08",{"date":98,"type":85},"2014-09-03",{"date":100,"type":85},"2017-07-10",{"name":5,"class":6}]