[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100187570":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":23,"locations":23,"responsibleParty":39,"collaborators":41,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":23,"eligibilityCriteria":50,"healthyVolunteers":51,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":23,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":23,"overallStatus":64,"whyStopped":23,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":23},{"fullName":5,"class":6},"Merck Sharp & Dohme LLC","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Raltegravir Film-coated Tablet","EXPERIMENTAL","Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks",[13,14],"Drug: Raltegravir Film-coated Tablet","Drug: Other Anti-Retroviral Therapy",{"label":16,"type":10,"description":17,"interventionNames":18},"Raltegravir Chewable Tablet","Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks",[19,14],"Drug: Raltegravir Chewable Tablet",[21,28,31],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG",null,[9],[26,27],"ISENTRESS®","MK-0518",{"type":22,"name":16,"description":23,"armGroupLabels":29,"otherNames":30},[16],[26,27],{"type":22,"name":32,"description":33,"armGroupLabels":34,"otherNames":23},"Other Anti-Retroviral Therapy","At baseline, the investigator selected the other anti-retroviral therapies to be used in combination with raltegravir based on current treatment guidelines, the participant's treatment history, and prior anti-retroviral resistance testing",[16,9],[36],{"name":37,"affiliation":5,"role":38},"Medical Director","STUDY_DIRECTOR",{"type":40,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[42],{"name":43,"class":6},"Covance","100187570","phase-2-a-study-of-the-safety-tolerability-and-antiretroviral-activity-of-raltegravir-mk-0518-in-combination-with-other-antiretroviral-therapies-in-russian-children-and-adolescents-infected-with-human-immunodeficiency-virus-hiv-1-mk-0518-248-100187570",true,"NCT01717287","A Study of the Safety, Tolerability, and Antiretroviral Activity of Raltegravir (MK-0518) in Combination With Other Antiretroviral Therapies in Russian Children and Adolescents Infected With Human Immunodeficiency Virus (HIV-1) (MK-0518-248)","A Phase II, Multicenter, Open-Label, Noncomparative Study of Raltegravir (MK-0518) in Two Oral Formulations in Combination With Other Antiretroviral Agents to Evaluate the Safety, Tolerability, and Antiretroviral Activity in HIV-1 Infected Russian Children and Adolescents","Inclusion Criteria:\n\n* HIV positive\n* Weight of at least 7 kg\n* HIV RNA ≥1000 copies\u002FmL within 45 days before study treatment\n* Participants of reproductive potential and sexually active agree to remain\n\nabstinent or use (or have their partner use) an acceptable method of birth control throughout the study.\n\nExclusion Criteria:\n\n* Females pregnant or breast-feeding, or expecting to conceive or donate eggs\n\nduring the study; males planning to impregnate or provide sperm donation\n\nduring the study\n\n* Use of any non-antiretroviral (ART) investigational agents within one month before study treatment\n* Current (active) diagnosis of acute hepatitis or chronic hepatitis other than stable chronic Hepatitis B and\u002For C\n* Prior or current use of raltegravir\n* Use of another experimental HIV-integrase inhibitor\n* History or current evidence of any condition, therapy, laboratory\n\nabnormality, or other circumstance that might confound the results of the study, or interfere with participation for the full duration of the study\n\n* Requires or is anticipated to require any prohibited medications\n* Use of immunosuppressive therapy within 30 days before beginning\n\nraltegravir study treatment; short courses of corticosteroids are permitted.\n\n* History of malignancy\n* Current treatment for active tuberculosis infection\n* Use of recreational or illicit drugs or a recent history (within the\n\nlast year) of drug or alcohol abuse or dependence",false,"ALL","2 Years","17 Years",{"count":56,"type":57},32,"ACTUAL","INTERVENTIONAL",[60],"PHASE2","This multicenter, open-label, noncomparative study evaluates two oral formulations of raltegravir (MK-0518, film-coated tablet and chewable tablet) in combination with other antiretroviral agents for safety, tolerability, and antiretroviral activity in treatment-naive or treatment-experienced Russian children and adolescents infected with human immunodeficiency virus-1 (HIV-1).\n\nAs raltegravir is indicated in combination with other antiretroviral therapies (ARTs) for the treatment of HIV-1 infection in pediatric patients in the United States (US), this study is designed to gain local treatment experience on the use\n\nof raltegravir in the pediatric HIV-infected population in Russia.",[63],"HIV Infection","COMPLETED","2018-07-23",{"date":67,"type":57},"2018-08-21",{"date":69,"type":57},"2012-11-16",{"date":71,"type":57},"2013-12-11",{"name":5,"class":6}]