[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659277":3},{"organization":4,"outcomesModule":7,"designInfo":65,"detailedDescription":64,"studyPopulation":64,"armGroups":71,"interventions":78,"overallOfficials":64,"centralContacts":64,"locations":64,"responsibleParty":85,"collaborators":64,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":64,"eligibilityCriteria":93,"healthyVolunteers":89,"sex":94,"minAge":64,"maxAge":95,"enrollmentInfo":96,"targetDuration":64,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":64,"overallStatus":106,"whyStopped":64,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":64},{"fullName":5,"class":6},"Merck Sharp & Dohme LLC","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":35,"otherOutcomes":64},[9,13,16,19,22,25,28,32],{"measure":10,"description":11,"timeFrame":12},"Area under the plasma conentration-time curve from dosing to 24 hours postdose (AUC0-24) of ISL","The plasma AUC0-24 will be assessed.","At designated timepoints on Day 28",{"measure":14,"description":15,"timeFrame":12},"Maximum plasma concentration (Cmax) of ISL","The plasma Cmax will be assessed.",{"measure":17,"description":18,"timeFrame":12},"Time to maximum plasma concentration (Tmax) of ISL","The plasma Tmax will be assessed.",{"measure":20,"description":21,"timeFrame":12},"Apparent plasma terminal half-life (t½) of ISL","The plasma t½ will be assessed.",{"measure":23,"description":24,"timeFrame":12},"Apparent clearance (CL\u002FF) of ISL","The CL\u002FF will be assessed.",{"measure":26,"description":27,"timeFrame":12},"Volume of distribution (Vz\u002FF) of ISL","The Vz\u002FF will be assessed.",{"measure":29,"description":30,"timeFrame":31},"Percentage of participants with ≥1 adverse event (AE) through Week 24","The percentage of participants with AE(s) will be assessed.","Up to ~24 weeks",{"measure":33,"description":34,"timeFrame":31},"Percentage of participants discontinuing from study therapy due to AE(s) through Week 24","The percentage of participants discontinuing from therapy due to AE(s) will be assessed.",[36,39,41,45,48,51,54,57,60],{"measure":37,"description":30,"timeFrame":38},"Percentage of participants with ≥1 AE through Week 96","Up to 96 weeks",{"measure":40,"description":30,"timeFrame":38},"Percentage of participants discontinuing from study therapy due to AE(s) through Week 96",{"measure":42,"description":43,"timeFrame":44},"Percentage of virologically-suppressed (VS) participants with Human Immunodeficiency Virus Type 1 (HIV-1) ribonucleic acid (RNA) ≥50 copies\u002FmL","The percentage of VS participants with HIV-1 RNA ≥50 copies\u002FmL will be assessed.","Weeks 24, 48, and 96",{"measure":46,"description":47,"timeFrame":44},"Percentage of VS participants with HIV-1 RNA \u003C50 copies\u002FmL","The percentage of VS participants with HIV-1 RNA \\\u003C50 copies\u002FmL will be assessed.",{"measure":49,"description":50,"timeFrame":44},"Percentage of VS participants with HIV-1 RNA \u003C200 copies\u002FmL","The percentage of VS participants with HIV-1 RNA \\\u003C200 copies\u002FmL will be assessed.",{"measure":52,"description":53,"timeFrame":44},"Percentage of treatment-naive (TN) participants with HIV-1 RNA \u003C50 copies\u002FmL","The percentage of TN participants with HIV-1 RNA \\\u003C50 copies\u002FmL will be assessed.",{"measure":55,"description":56,"timeFrame":44},"Percentage of TN participants with HIV-1 RNA \u003C200 copies\u002FmL","The percentage of TN participants with HIV-1 RNA \\\u003C200 copies\u002FmL will be assessed.",{"measure":58,"description":59,"timeFrame":44},"Change from baseline in CD4+ T-cell counts in VS and TN participants","The change from baseline in CD4+ T-cell counts will be assessed in VS and TN participants.",{"measure":61,"description":62,"timeFrame":63},"Percentage of participants with viral drug resistance to DOR or ISL","The percentage of participants with viral resistance-associated substitutions will be assessed during Weeks 24, 48, 96, and 144.","Weeks 24, 48, 96, and 144",null,{"allocation":66,"interventionModel":67,"interventionModelDescription":64,"primaryPurpose":68,"observationalModel":64,"timePerspective":64,"maskingInfo":69},"NA","SINGLE_GROUP","TREATMENT",{"masking":70,"maskingDescription":64,"whoMasked":64},"NONE",[72],{"label":73,"type":74,"description":75,"interventionNames":76},"DOR\u002FISL","EXPERIMENTAL","Participants receive DOR\u002FISL 100 mg\u002F0.25 mg once daily (qd) for 96 weeks. Participants will have the option to participate in the Study Extension and receive DOR\u002FISL until Week 240 or it becomes commercially available, whichever is first.",[77],"Drug: DOR\u002FISL",[79],{"type":80,"name":73,"description":81,"armGroupLabels":82,"otherNames":83},"DRUG","DOR\u002FISL 100 mg\u002F0.25 mg tablet taken by mouth qd",[73],[84],"MK-8591A",{"type":86,"investigatorFullName":64,"investigatorTitle":64,"investigatorAffiliation":64,"oldNameTitle":64,"oldOrganization":64},"SPONSOR","100659277","phase-2-dorisl-in-pediatric-participants-with-hiv-1-18-years-of-age-and--35-kg-100659277",false,"NCT07862569","DOR\u002FISL in Pediatric Participants With HIV-1, \u003C18 Years of Age and ≥ 35 kg","A Phase 2 Clinical Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Oral Doravirine\u002FIslatravir (100 mg\u002F0.25 mg) in Pediatric Participants With HIV-1 Infection Who Are Virologically Suppressed or Treatment-Naïve, Are Less Than 18 Years of Age, and Weigh Greater Than or Equal to 35 kg","Inclusion Criteria:\n\n* Pediatric participant with HIV-1 \\\u003C18 years of age\n* Body weight ≥35 kg\n* Is TN (HIV-1 positive with plasma HIV-1 RNA ≥500 copies\u002FmL) or VS (HIV-1 positive at screening with plasma HIV-1 RNA \\\u003C50 copies\u002FmL AND has received stable, continuous 2- or 3-drug antiretroviral therapy (ART) for ≥3 months prior to providing informed consent)\n\nExclusion Criteria:\n\n* HIV-2 infection\n* Hypsensitivity\u002Fcontraindication to any components of study medication or as determined by the investigator\n* Has an active diagnosis of hepatitis due to any cause\n* history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or cutaneous Kaposi's sarcoma\n* Has a history or current evidence of any condition (including active tuberculosis infection, COVID-19, or other infections), therapy, laboratory abnormality, or other circumstance (including drug or alcohol use or dependence) that might, in the opinion of the investigator, confound the results of the study\n* Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or any prohibited therapies","ALL","18 Years",{"count":97,"type":98},45,"ESTIMATED","INTERVENTIONAL",[101],"PHASE2","This is a phase 2 study of the pharmacokinetics, safety, and efficacy of oral doravirine\u002Fislatravir (100 mg\u002F0.25 mg) \\[MK-8591A\\] in pediatric participants with human immunodeficiency virus type 1 (HIV-1) infection who are virologically suppressed or treatment-naive.\n\nThe Base Study will last from Day 1 to Week 96. At Week 96, participants will be given the option to participate in an optional Study Extension and receive DOR\u002FISL until Week 240 or until it becomes commercially accessible, whichever is first.",[104,105],"HIV-1","HIV Infection","NOT_YET_RECRUITING","2026-10-02",{"date":109,"type":110},"2026-10-07","ACTUAL",{"date":112,"type":98},"2026-12-23",{"date":114,"type":98},"2033-12-23",{"name":5,"class":6}]