[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613456":3},{"organization":4,"outcomesModule":7,"designInfo":93,"detailedDescription":92,"studyPopulation":92,"armGroups":103,"interventions":128,"overallOfficials":165,"centralContacts":169,"locations":175,"responsibleParty":843,"collaborators":92,"id":845,"slug":846,"hasResults":847,"nctId":848,"briefTitle":849,"officialTitle":850,"acronym":92,"eligibilityCriteria":851,"healthyVolunteers":847,"sex":852,"minAge":853,"maxAge":92,"enrollmentInfo":854,"targetDuration":92,"studyType":857,"phases":858,"briefSummary":861,"conditions":862,"keywords":92,"overallStatus":178,"whyStopped":92,"lastUpdateSubmitDate":864,"lastUpdatePostDateStruct":865,"startDateStruct":868,"completionDateStruct":870,"leadSponsor":872,"locationsCount":873},{"fullName":5,"class":6},"Merck Sharp & Dohme LLC","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":26,"otherOutcomes":92},[9,13,16,18,22,24],{"measure":10,"description":11,"timeFrame":12},"Phase 2: Percentage of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) \u003C50 Copies\u002FmL at Week 24","Plasma HIV-1 ribonucleic acid (RNA) quantification will be performed at the central laboratory using a polymerase chain reaction (PCR) assay. Percentage of participants with HIV-1 RNA \\\u003C50 copies\u002FmL will be reported at week 24.","Week 24",{"measure":14,"description":15,"timeFrame":12},"Phase 2: Percentage of Participants Who Experience an Adverse Event (AE) at Week 24","An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.",{"measure":17,"description":15,"timeFrame":12},"Phase 2: Percentage of Participants Who Discontinue Study Intervention Due to an AE at Week 24",{"measure":19,"description":20,"timeFrame":21},"Phase 3: Percentage of Participants With HIV-1 RNA \u003C50 Copies\u002FmL at Week 48","Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay. Percentage of participants with HIV-1 RNA \\\u003C50 copies\u002FmL will be reported at week 48.","Week 48",{"measure":23,"description":15,"timeFrame":21},"Phase 3: Percentage of Participants Who Experience an AE at Week 48",{"measure":25,"description":15,"timeFrame":21},"Phase 3: Percentage of Participants Who Discontinue Study Intervention Due to an AE at Week 48",[27,29,33,36,39,42,46,50,54,57,60,63,66,69,71,73,75,77,79,81,83,85,87,90],{"measure":28,"description":20,"timeFrame":21},"Phase 2: Percentage of Participants With HIV-1 RNA \u003C50 Copies\u002FmL at Week 48",{"measure":30,"description":31,"timeFrame":32},"Phase 2: Percentage of Participants With HIV-1 RNA \u003C50 Copies\u002FmL at Week 96","Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay. Percentage of participants with HIV-1 RNA \\\u003C50 copies\u002FmL will be reported at week 96.","Week 96",{"measure":34,"description":35,"timeFrame":12},"Phase 2: Percentage of Participants With HIV-1 RNA \u003C200 Copies\u002FmL at Week 24","Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay. Percentage of participants with HIV-1 RNA \\\u003C200 copies\u002FmL will be reported at week 24.",{"measure":37,"description":38,"timeFrame":21},"Phase 2: Percentage of Participants With HIV-1 RNA \u003C200 Copies\u002FmL at Week 48","Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay. Percentage of participants with HIV-1 RNA \\\u003C200 copies\u002FmL will be reported at week 48.",{"measure":40,"description":41,"timeFrame":32},"Phase 2: Percentage of Participants With HIV-1 RNA \u003C200 Copies\u002FmL at Week 96","Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay. Percentage of participants with HIV-1 RNA \\\u003C200 copies\u002FmL will be reported at week 96.",{"measure":43,"description":44,"timeFrame":45},"Phase 2: Mean Change From Baseline in Cluster of Differentiation 4-Positive (CD4+) T-Cell Count at Week 24","Blood samples will be collected to measure CD4+ T-cell count. The mean change from baseline in CD4+ T-cell count will be calculated at 24 weeks.","Baseline (Day 1) and Week 24",{"measure":47,"description":48,"timeFrame":49},"Phase 2: Mean Change From Baseline in CD4+ T-Cell Count at Week 48","Blood samples will be collected to measure CD4+ T-cell count. The mean change from baseline in CD4+ T-cell count will be calculated at 48 weeks.","Baseline (Day 1) and Week 48",{"measure":51,"description":52,"timeFrame":53},"Phase 2: Mean Change From Baseline in CD4+ T-Cell Count at Week 96","Blood samples will be collected to measure CD4+ T-cell count. The mean change from baseline in CD4+ T-cell count will be calculated at 96 weeks.","Baseline (Day 1) and Week 96",{"measure":55,"description":15,"timeFrame":56},"Phase 2: Percentage of Participants Who Experience an AE","Up to approximately 102 weeks",{"measure":58,"description":15,"timeFrame":59},"Phase 2: Percentage of Participants Who Discontinue Study Intervention Due to an AE","Up to approximately 96 weeks",{"measure":61,"description":62,"timeFrame":12},"Phase 2: Number of Participants With Evidence of Viral Drug Resistance-Associated Substitutions at Week 24","Participants who meet the definition of clinically significant confirmed viremia (CSCV) or who discontinue study intervention for another reason and have HIV-1 RNA ≥200 copies\u002FmL at the time of discontinuation, will be assessed for development of viral drug resistance. Among such participants, those with confirmed HIV-1 RNA ≥400 copies\u002FmL will be included in the resistance analyses set. In addition, anyone for whom available genotypic and\u002For phenotypic data show evidence of resistance, irrespective of viral load, will also be included in the resistance analyses set. The number of participants in each treatment group who have evidence of resistance-associated substitutions at week 24 will be presented.",{"measure":64,"description":65,"timeFrame":21},"Phase 2: Number of Participants With Evidence of Viral Drug Resistance-Associated Substitutions at Week 48","Participants who meet the definition of clinically significant confirmed viremia (CSCV) or who discontinue study intervention for another reason and have HIV-1 RNA ≥200 copies\u002FmL at the time of discontinuation, will be assessed for development of viral drug resistance. Among such participants, those with confirmed HIV-1 RNA ≥400 copies\u002FmL will be included in the resistance analyses set. In addition, anyone for whom available genotypic and\u002For phenotypic data show evidence of resistance, irrespective of viral load, will also be included in the resistance analyses set. The number of participants in each treatment group who have evidence of resistance-associated substitutions at week 48 will be presented.",{"measure":67,"description":68,"timeFrame":32},"Phase 2: Number of Participants With Evidence of Viral Drug Resistance-Associated Substitutions at Week 96","Participants who meet the definition of clinically significant confirmed viremia (CSCV) or who discontinue study intervention for another reason and have HIV-1 RNA ≥200 copies\u002FmL at the time of discontinuation, will be assessed for development of viral drug resistance. Among such participants, those with confirmed HIV-1 RNA ≥400 copies\u002FmL will be included in the resistance analyses set. In addition, anyone for whom available genotypic and\u002For phenotypic data show evidence of resistance, irrespective of viral load, will also be included in the resistance analyses set. The number of participants in each treatment group who have evidence of resistance-associated substitutions at week 96 will be presented.",{"measure":70,"description":31,"timeFrame":32},"Phase 3: Percentage of Participants With HIV-1 RNA \u003C50 Copies\u002FmL at Week 96",{"measure":72,"description":38,"timeFrame":21},"Phase 3: Percentage of Participants With HIV-1 RNA \u003C200 Copies\u002FmL at Week 48",{"measure":74,"description":41,"timeFrame":32},"Phase 3: Percentage of Participants With HIV-1 RNA \u003C200 Copies\u002FmL at Week 96",{"measure":76,"description":48,"timeFrame":49},"Phase 3: Mean Change From Baseline in Cluster of Differentiation 4-Positive (CD4+) T-Cell Count at Week 48",{"measure":78,"description":52,"timeFrame":53},"Phase 3: Mean Change From Baseline in Cluster of Differentiation 4-Positive (CD4+) T-Cell Count at Week 96",{"measure":80,"description":15,"timeFrame":56},"Phase 3: Percentage of Participants Who Experience an AE",{"measure":82,"description":15,"timeFrame":59},"Phase 3: Percentage of Participants Who Discontinue Study Intervention Due to an AE",{"measure":84,"description":65,"timeFrame":21},"Phase 3: Number of Participants With Evidence of Viral Drug Resistance-Associated Substitutions at Week 48",{"measure":86,"description":68,"timeFrame":32},"Phase 3: Number of Participants With Evidence of Viral Drug Resistance-Associated Substitutions at Week 96",{"measure":88,"description":89,"timeFrame":49},"Phase 3: Mean Change From Baseline in Body Weight at Week 48","Body weight will be collected throughout the study.",{"measure":91,"description":89,"timeFrame":53},"Phase 3: Mean Change From Baseline in Body Weight at Week 96",null,{"allocation":94,"interventionModel":95,"interventionModelDescription":92,"primaryPurpose":96,"observationalModel":92,"timePerspective":92,"maskingInfo":97},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":98,"maskingDescription":99,"whoMasked":100},"DOUBLE","Phase 2: no masking Phase 3: Participant, Sponsor, and Investigator are masked",[101,102],"PARTICIPANT","INVESTIGATOR",[104,111,117,123],{"label":105,"type":106,"description":107,"interventionNames":108},"Phase 2: ISL + ULO","EXPERIMENTAL","Islatravir (ISL) 2mg and Ulonivirine (ULO) 200mg administered orally once weekly (qw) for 96 weeks",[109,110],"Drug: ISL","Drug: ULO",{"label":112,"type":113,"description":114,"interventionNames":115},"Phase 2: BIC\u002FFTC\u002FTAF","ACTIVE_COMPARATOR","Bictegravir\u002FEmtricitabine\u002FTenofovir Alafenamide (BIC\u002FFTC\u002FTAF) 50\u002F200\u002F25 mg, administered orally once daily (qd) for 96 weeks",[116],"Drug: BIC\u002FFTC\u002FTAF",{"label":118,"type":106,"description":119,"interventionNames":120},"Phase 3: ISL\u002FULO and Placebo to BIC\u002FFTC\u002FTAF","ISL\u002FULO fixed dose combination (2\u002F200 mg), administered orally qw, and matching placebo to BIC\u002FFTC\u002FTAF administered orally qd for 96 weeks",[121,122],"Drug: Placebo for BIC\u002FFTC\u002FTAF","Drug: ISL\u002FULO",{"label":124,"type":113,"description":125,"interventionNames":126},"Phase 3: BIC\u002FFTC\u002FTAF and Placebo to ISL\u002FULO","BIC\u002FFTC\u002FTAF 50\u002F200\u002F25 mg, administered orally qd, and matching placebo to ISL\u002FULO administered orally qw for 96 weeks",[116,127],"Drug: Placebo to ISL\u002FULO",[129,137,144,151,155,159],{"type":130,"name":131,"description":132,"armGroupLabels":133,"otherNames":134},"DRUG","ISL","ISL 2 x 1 mg oral capsules administered qw for 96 weeks",[105],[135,136],"islatravir","MK-8591",{"type":130,"name":138,"description":139,"armGroupLabels":140,"otherNames":141},"ULO","ULO 2 x 100 mg oral tablets administered qw for 96 weeks",[105],[142,143],"ulonivirine","MK-8507",{"type":130,"name":145,"description":146,"armGroupLabels":147,"otherNames":148},"BIC\u002FFTC\u002FTAF","BIC\u002FFTC\u002FTAF 50\u002F200\u002F25 mg oral tablet administered qd for 96 weeks",[112,124],[149,150],"bictegravir\u002Femtricitabine\u002Ftenofovir alafenamide","BIKTARVY®",{"type":130,"name":152,"description":153,"armGroupLabels":154,"otherNames":92},"Placebo for BIC\u002FFTC\u002FTAF","BIC\u002FFTC\u002FTAF-matching placebo oral tablet administered qd for 96 weeks",[118],{"type":130,"name":156,"description":157,"armGroupLabels":158,"otherNames":92},"Placebo to ISL\u002FULO","ISL\u002FULO-matching placebo oral tablets administered qw for 96 weeks",[124],{"type":130,"name":160,"description":161,"armGroupLabels":162,"otherNames":163},"ISL\u002FULO","ISL\u002FULO fixed-dose combination 2 mg\u002F200 mg oral tablet administered qw for 96 weeks",[118],[164],"MK-8591B",[166],{"name":167,"affiliation":5,"role":168},"Medical Director","STUDY_DIRECTOR",[170],{"name":171,"role":172,"phone":173,"phoneExt":92,"email":174},"Toll Free Number","CONTACT","1-888-577-8839","Trialsites@msd.com",[176,194,207,220,233,245,257,269,281,294,306,319,332,345,358,371,383,396,409,422,434,441,453,465,478,488,495,507,519,532,545,560,573,588,597,603,618,631,644,657,670,682,691,705,713,722,737,752,765,773,788,801,813,822,831],{"facility":177,"status":178,"city":179,"state":180,"zip":181,"country":182,"countryCode":183,"cosmosGeoPoint":184,"geoPoint":189,"contacts":190},"Ruane Clinical Research Group, Inc. ( Site 1513)","RECRUITING","Los Angeles","California","90036","United States","US",{"type":185,"coordinates":186},"Point",[187,188],-118.24368,34.05223,{"lat":188,"lon":187},[191],{"name":192,"role":172,"phone":193,"phoneExt":92,"email":92},"Study Coordinator","323-954-0400",{"facility":195,"status":178,"city":196,"state":197,"zip":198,"country":182,"countryCode":183,"cosmosGeoPoint":199,"geoPoint":203,"contacts":204},"Vivent Health ( Site 1519)","Denver","Colorado","80246",{"type":185,"coordinates":200},[201,202],-104.9847,39.73915,{"lat":202,"lon":201},[205],{"name":192,"role":172,"phone":206,"phoneExt":92,"email":92},"303-393-8050",{"facility":208,"status":178,"city":209,"state":210,"zip":211,"country":182,"countryCode":183,"cosmosGeoPoint":212,"geoPoint":216,"contacts":217},"Whitman-Walker Institute ( Site 1538)","Washington D.C.","District of Columbia","20032",{"type":185,"coordinates":213},[214,215],-77.03637,38.89511,{"lat":215,"lon":214},[218],{"name":192,"role":172,"phone":219,"phoneExt":92,"email":92},"202-207-2510",{"facility":221,"status":178,"city":222,"state":223,"zip":224,"country":182,"countryCode":183,"cosmosGeoPoint":225,"geoPoint":229,"contacts":230},"Midway Immunology and Research Center ( Site 1503)","Ft. Pierce","Florida","34982",{"type":185,"coordinates":226},[227,228],-80.32561,27.44671,{"lat":228,"lon":227},[231],{"name":192,"role":172,"phone":232,"phoneExt":92,"email":92},"772-595-9830",{"facility":234,"status":178,"city":235,"state":223,"zip":236,"country":182,"countryCode":183,"cosmosGeoPoint":237,"geoPoint":241,"contacts":242},"CAN Community Health- Miami Gardens ( Site 1549)","Miami Gardens","33055",{"type":185,"coordinates":238},[239,240],-80.2456,25.94204,{"lat":240,"lon":239},[243],{"name":192,"role":172,"phone":244,"phoneExt":92,"email":92},"954-955-0023",{"facility":246,"status":178,"city":247,"state":223,"zip":248,"country":182,"countryCode":183,"cosmosGeoPoint":249,"geoPoint":253,"contacts":254},"Orlando Immunology Center ( Site 1501)","Orlando","32803",{"type":185,"coordinates":250},[251,252],-81.37924,28.53834,{"lat":252,"lon":251},[255],{"name":192,"role":172,"phone":256,"phoneExt":92,"email":92},"407-374-0220",{"facility":258,"status":178,"city":259,"state":223,"zip":260,"country":182,"countryCode":183,"cosmosGeoPoint":261,"geoPoint":265,"contacts":266},"CAN Community Health ( Site 1510)","Sarasota","34237",{"type":185,"coordinates":262},[263,264],-82.53065,27.33643,{"lat":264,"lon":263},[267],{"name":192,"role":172,"phone":268,"phoneExt":92,"email":92},"941-366-0134",{"facility":270,"status":178,"city":271,"state":223,"zip":272,"country":182,"countryCode":183,"cosmosGeoPoint":273,"geoPoint":277,"contacts":278},"Triple O Research Institute ( Site 1505)","West Palm Beach","33407",{"type":185,"coordinates":274},[275,276],-80.05337,26.71534,{"lat":276,"lon":275},[279],{"name":192,"role":172,"phone":280,"phoneExt":92,"email":92},"561-855-7871",{"facility":282,"status":178,"city":283,"state":284,"zip":285,"country":182,"countryCode":183,"cosmosGeoPoint":286,"geoPoint":290,"contacts":291},"Metro Infectious Diseases Consultants L.L.C. 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