[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598448":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":43,"centralContacts":47,"locations":53,"responsibleParty":382,"collaborators":28,"id":384,"slug":28,"hasResults":385,"nctId":386,"briefTitle":387,"officialTitle":388,"acronym":28,"eligibilityCriteria":389,"healthyVolunteers":390,"sex":391,"minAge":392,"maxAge":393,"enrollmentInfo":394,"targetDuration":28,"studyType":397,"phases":398,"briefSummary":400,"conditions":401,"keywords":28,"overallStatus":56,"whyStopped":28,"lastUpdateSubmitDate":404,"lastUpdatePostDateStruct":405,"startDateStruct":408,"completionDateStruct":410,"leadSponsor":412,"locationsCount":413},{"fullName":5,"class":6},"Merck Sharp & Dohme LLC","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"MK-8527 + Placebo to FTC\u002FTDF","EXPERIMENTAL","Participants will receive 11 mg MK-8527 once monthly (QM) and placebo matched to Emtricitabine\u002FTenofovir Disoproxil Fumarate (FTC\u002FTDF) once daily (QD) for up to approximately 2 years. Participants will then receive open-label 200 mg FTC\u002F245 mg TDF QD for an additional 28 days.",[13,14],"Drug: MK-8527","Drug: Placebo matched to FTC\u002FTDF",{"label":16,"type":17,"description":18,"interventionNames":19},"FTC\u002FTDF + Placebo to MK-8527","ACTIVE_COMPARATOR","Participants will receive 200 mg FTC\u002F245 mg TDF QD and placebo matched to MK-8527 QM for up to approximately 2 years. Participants will then receive open-label 200 mg FTC\u002F245 mg TDF QD for an additional 28 days.",[20,21],"Drug: Emtricitabine\u002Ftenofovir disoproxil (FTC\u002FTDF)","Drug: Placebo matched to MK-8527",[23,29,35,39],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","MK-8527","Oral tablet",[9],null,{"type":24,"name":30,"description":26,"armGroupLabels":31,"otherNames":32},"Emtricitabine\u002Ftenofovir disoproxil (FTC\u002FTDF)",[16],[33,34],"Truvada","Emtricitabine\u002FTenofovir Disoproxil Fumarate",{"type":24,"name":36,"description":37,"armGroupLabels":38,"otherNames":28},"Placebo matched to MK-8527","Placebo oral tablet matched to MK-8527",[16],{"type":24,"name":40,"description":41,"armGroupLabels":42,"otherNames":28},"Placebo matched to FTC\u002FTDF","Placebo oral tablet matched to FTC\u002FTDF",[9],[44],{"name":45,"affiliation":5,"role":46},"Medical Director","STUDY_DIRECTOR",[48],{"name":49,"role":50,"phone":51,"phoneExt":28,"email":52},"Toll Free Number","CONTACT","1-888-577-8839","Trialsites@msd.com",[54,65,72,80,93,107,119,132,145,154,161,173,186,198,207,215,224,236,248,260,272,279,291,304,313,325,339,347,360,370],{"facility":55,"status":56,"city":57,"state":58,"zip":59,"country":60,"cosmosGeoPoint":28,"geoPoint":28,"contacts":61},"UW - KNH; Rachuonyo County Hospital ( Site 0006)","RECRUITING","Homabay County","Homa Bay County","40222","Kenya",[62],{"name":63,"role":50,"phone":64,"phoneExt":28,"email":28},"Study Coordinator","+254723479756",{"facility":66,"status":56,"city":67,"state":68,"zip":69,"country":60,"cosmosGeoPoint":28,"geoPoint":28,"contacts":70},"Partners in Health and Research Development (PHRD) ( Site 0002)","Thika","Kiambu County","00202",[71],{"name":63,"role":50,"phone":51,"phoneExt":28,"email":28},{"facility":73,"status":56,"city":74,"state":75,"zip":76,"country":60,"cosmosGeoPoint":28,"geoPoint":28,"contacts":77},"KEMRI-CMR-RCTP ( Site 0003)","Nairobi","Kisumu County","00200",[78],{"name":63,"role":50,"phone":79,"phoneExt":28,"email":28},"+254202600017",{"facility":81,"status":56,"city":82,"state":28,"zip":83,"country":60,"cosmosGeoPoint":84,"geoPoint":89,"contacts":90},"Kargeno Research & Policy Hub ( Site 0007)","Kisumu","40123",{"type":85,"coordinates":86},"Point",[87,88],34.76171,-0.10221,{"lat":88,"lon":87},[91],{"name":63,"role":50,"phone":92,"phoneExt":28,"email":28},"+254732390992",{"facility":94,"status":56,"city":95,"state":96,"zip":97,"country":98,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"Synergy Biomed Research Institute ( Site 0040)","East London","Eastern Cape","5241","South Africa",{"type":85,"coordinates":100},[101,102],27.91162,-33.01529,{"lat":102,"lon":101},[105],{"name":63,"role":50,"phone":106,"phoneExt":28,"email":28},"+27437222306",{"facility":108,"status":56,"city":109,"state":96,"zip":110,"country":98,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"Foundation For Professional Development ( Site 0031)","Ndevana","5660",{"type":85,"coordinates":112},[113,114],27.50973,-32.90769,{"lat":114,"lon":113},[117],{"name":63,"role":50,"phone":118,"phoneExt":28,"email":28},"+27672388219",{"facility":120,"status":56,"city":121,"state":122,"zip":123,"country":98,"cosmosGeoPoint":124,"geoPoint":128,"contacts":129},"Josha Research ( Site 0045)","Bloemfontein","Free State","9301",{"type":85,"coordinates":125},[126,127],26.214,-29.12107,{"lat":127,"lon":126},[130],{"name":63,"role":50,"phone":131,"phoneExt":28,"email":28},"+27 51 412 8160",{"facility":133,"status":56,"city":134,"state":135,"zip":136,"country":98,"cosmosGeoPoint":137,"geoPoint":141,"contacts":142},"Wits RHI Ward 21 Clinical Research site ( Site 0022)","Johannesburg","Gauteng","2001",{"type":85,"coordinates":138},[139,140],28.04363,-26.20227,{"lat":140,"lon":139},[143],{"name":63,"role":50,"phone":144,"phoneExt":28,"email":28},"+27823776275",{"facility":146,"status":56,"city":134,"state":135,"zip":147,"country":98,"cosmosGeoPoint":148,"geoPoint":150,"contacts":151},"Helen Joseph Hospital-Clinical HIV Research Unit ( Site 0048)","2092",{"type":85,"coordinates":149},[139,140],{"lat":140,"lon":139},[152],{"name":63,"role":50,"phone":153,"phoneExt":28,"email":28},"+27112768800",{"facility":155,"status":56,"city":156,"state":135,"zip":157,"country":98,"cosmosGeoPoint":28,"geoPoint":28,"contacts":158},"Perinatal HIV Research Unit (PHRU) ( Site 0033)","Johnnesburg","1864",[159],{"name":63,"role":50,"phone":160,"phoneExt":28,"email":28},"+27 11 989 9711",{"facility":162,"status":56,"city":163,"state":135,"zip":164,"country":98,"cosmosGeoPoint":165,"geoPoint":169,"contacts":170},"Setshaba Research Centre ( Site 0032)","Pretoria","0152",{"type":85,"coordinates":166},[167,168],28.18783,-25.74486,{"lat":168,"lon":167},[171],{"name":63,"role":50,"phone":172,"phoneExt":28,"email":28},"0127992422",{"facility":174,"status":56,"city":175,"state":176,"zip":177,"country":98,"cosmosGeoPoint":178,"geoPoint":182,"contacts":183},"SA Medical Research Council - Chatsworth Clinical Research Site ( Site 0026)","Chatsworth","KwaZulu-Natal","4092",{"type":85,"coordinates":179},[180,181],30.8917,-29.91866,{"lat":181,"lon":180},[184],{"name":63,"role":50,"phone":185,"phoneExt":28,"email":28},"0314014150",{"facility":187,"status":56,"city":188,"state":176,"zip":189,"country":98,"cosmosGeoPoint":190,"geoPoint":194,"contacts":195},"SA Medical Research Council - Botha's Hill Clinical Research Site ( Site 0035)","Durban","3660",{"type":85,"coordinates":191},[192,193],31.0292,-29.8579,{"lat":193,"lon":192},[196],{"name":63,"role":50,"phone":197,"phoneExt":28,"email":28},"+27312423647",{"facility":199,"status":56,"city":188,"state":176,"zip":200,"country":98,"cosmosGeoPoint":201,"geoPoint":203,"contacts":204},"CAPRISA eThekwini Clinical Research Site ( Site 0030)","4001",{"type":85,"coordinates":202},[192,193],{"lat":193,"lon":192},[205],{"name":63,"role":50,"phone":206,"phoneExt":28,"email":28},"+27312601961",{"facility":208,"status":56,"city":188,"state":176,"zip":200,"country":98,"cosmosGeoPoint":209,"geoPoint":211,"contacts":212},"Wits Maternal Adolescent and Child Health Research Unit (WMRU) ( Site 0027)",{"type":85,"coordinates":210},[192,193],{"lat":193,"lon":192},[213],{"name":63,"role":50,"phone":214,"phoneExt":28,"email":28},"+27 31 001 1900",{"facility":216,"status":56,"city":188,"state":176,"zip":217,"country":98,"cosmosGeoPoint":218,"geoPoint":220,"contacts":221},"Umlazi Clinical Research Site ( Site 0047)","4089",{"type":85,"coordinates":219},[192,193],{"lat":193,"lon":192},[222],{"name":63,"role":50,"phone":223,"phoneExt":28,"email":28},"+2731 260 1982",{"facility":225,"status":56,"city":226,"state":176,"zip":227,"country":98,"cosmosGeoPoint":228,"geoPoint":232,"contacts":233},"SYNAPSE Research Clinic ( Site 0043)","Edendale","3216",{"type":85,"coordinates":229},[230,231],30.31498,-29.65247,{"lat":231,"lon":230},[234],{"name":63,"role":50,"phone":235,"phoneExt":28,"email":28},"+27 73 297 2172",{"facility":237,"status":56,"city":238,"state":176,"zip":239,"country":98,"cosmosGeoPoint":240,"geoPoint":244,"contacts":245},"Qhakaza Mbokodo Research Clinic ( Site 0028)","Ladysmith","3370",{"type":85,"coordinates":241},[242,243],29.77896,-28.55874,{"lat":243,"lon":242},[246],{"name":63,"role":50,"phone":247,"phoneExt":28,"email":28},"+27366312372",{"facility":249,"status":56,"city":250,"state":176,"zip":251,"country":98,"cosmosGeoPoint":252,"geoPoint":256,"contacts":257},"SA Medical Research Council - Phoenix Clinical Research Site ( Site 0037)","Phoenix","4068",{"type":85,"coordinates":253},[254,255],31.0051,-29.70306,{"lat":255,"lon":254},[258],{"name":63,"role":50,"phone":259,"phoneExt":28,"email":28},"+27312423632",{"facility":261,"status":56,"city":262,"state":176,"zip":263,"country":98,"cosmosGeoPoint":264,"geoPoint":268,"contacts":269},"CAPRISA Vulindlela Clinical Research Site ( Site 0029)","Pietermaritzburg","3231",{"type":85,"coordinates":265},[266,267],30.39278,-29.61679,{"lat":267,"lon":266},[270],{"name":63,"role":50,"phone":271,"phoneExt":28,"email":28},"+2731 655 0694",{"facility":273,"status":56,"city":274,"state":176,"zip":275,"country":98,"cosmosGeoPoint":28,"geoPoint":28,"contacts":276},"Africa Health Research Institute (AHRI) - Mtubatuba ( Site 0049)","Somkhele - Mtubatuba","3935",[277],{"name":63,"role":50,"phone":278,"phoneExt":28,"email":28},"+27 35 251 0900",{"facility":280,"status":56,"city":281,"state":176,"zip":282,"country":98,"cosmosGeoPoint":283,"geoPoint":287,"contacts":288},"SA Medical Research Council - Verulam Clinical Research Site ( Site 0036)","Verulam","4340",{"type":85,"coordinates":284},[285,286],31.04709,-29.6434,{"lat":286,"lon":285},[289],{"name":63,"role":50,"phone":290,"phoneExt":28,"email":28},"+27325334145",{"facility":292,"status":56,"city":293,"state":294,"zip":295,"country":98,"cosmosGeoPoint":296,"geoPoint":300,"contacts":301},"Desmond Tutu Health Foundation. Philippi Village ( Site 0024)","Cape Town","Western Cape","7781",{"type":85,"coordinates":297},[298,299],18.42322,-33.92584,{"lat":299,"lon":298},[302],{"name":63,"role":50,"phone":303,"phoneExt":28,"email":28},"+27870572508",{"facility":305,"status":56,"city":293,"state":294,"zip":306,"country":98,"cosmosGeoPoint":307,"geoPoint":309,"contacts":310},"DTHF Masiphumelele Clinical Research Site ( Site 0023)","7795",{"type":85,"coordinates":308},[298,299],{"lat":299,"lon":298},[311],{"name":63,"role":50,"phone":312,"phoneExt":28,"email":28},"+27217855454",{"facility":314,"status":56,"city":315,"state":294,"zip":316,"country":98,"cosmosGeoPoint":317,"geoPoint":321,"contacts":322},"Vuka Research Clinic ( Site 0025)","Khayelitsha","7784",{"type":85,"coordinates":318},[319,320],18.67916,-34.03932,{"lat":320,"lon":319},[323],{"name":63,"role":50,"phone":324,"phoneExt":28,"email":28},"+27216501551",{"facility":326,"status":56,"city":327,"state":328,"zip":329,"country":330,"cosmosGeoPoint":331,"geoPoint":335,"contacts":336},"MRC\u002FUVRI and LSHTM Uganda Research Unit Masaka ( Site 0064)","Entebbe","Central Region","256","Uganda",{"type":85,"coordinates":332},[333,334],32.47949,0.05621,{"lat":334,"lon":333},[337],{"name":63,"role":50,"phone":338,"phoneExt":28,"email":28},"+256485660468",{"facility":340,"status":56,"city":341,"state":342,"zip":343,"country":330,"cosmosGeoPoint":28,"geoPoint":28,"contacts":344},"Infectious Diseases Institute Kalangala ( Site 0063)","Kalangala District","Kalangala","30060\u002F+256",[345],{"name":63,"role":50,"phone":346,"phoneExt":28,"email":28},"+256312211482",{"facility":348,"status":56,"city":349,"state":350,"zip":351,"country":330,"cosmosGeoPoint":352,"geoPoint":356,"contacts":357},"MU-JHU Research Collaboration - Mityana ( Site 0061)","Mityana, District","Mityana","30026\u002F+256",{"type":85,"coordinates":353},[354,355],32.02278,0.4175,{"lat":355,"lon":354},[358],{"name":63,"role":50,"phone":359,"phoneExt":28,"email":28},"+25760334881",{"facility":361,"status":56,"city":327,"state":362,"zip":363,"country":330,"cosmosGeoPoint":364,"geoPoint":366,"contacts":367},"UVRI Clinical Research Program Initiative Ltd (UVRI CRP) ( Site 0067)","Wakiso","30006",{"type":85,"coordinates":365},[333,334],{"lat":334,"lon":333},[368],{"name":63,"role":50,"phone":369,"phoneExt":28,"email":28},"+256312216100",{"facility":371,"status":56,"city":372,"state":28,"zip":373,"country":330,"cosmosGeoPoint":374,"geoPoint":378,"contacts":379},"MU-JHU Research Collaboration - Kampala ( Site 0062)","Kampala","10216\u002F+256",{"type":85,"coordinates":375},[376,377],32.58219,0.31628,{"lat":377,"lon":376},[380],{"name":63,"role":50,"phone":381,"phoneExt":28,"email":28},"+256703419772",{"type":383,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100598448",false,"NCT07071623","A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)","A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of MK-8527 Oral Once-Monthly as HIV-1 Preexposure Prophylaxis in Women","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Is confirmed Human Immunodeficiency Virus (HIV)-uninfected based on negative HIV-1\u002FHIV-2 test results\n* Has been sexually active (2 vaginal intercourse encounters with cisgender male individual(s) within the last 3 months)\n* Was assigned female sex at birth and is cisgender.\n* Weighs ≥35 kg\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has hypersensitivity or other contraindication to any component of the study interventions\n* Has evidence of acute or chronic hepatitis B infection\n* Has a history of malignancy within 5 years of screening except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer\n* Has taken cabotegravir, lenacapavir, or any other long-acting HIV prevention product at any time\n* Is receiving or is anticipated to require any prohibited therapies from 30 days prior to Day 1 through the study duration\n* Has received an HIV vaccine at any time (ie, through past participation in an investigational clinical study) or monoclonal antibodies to HIV within 12 months before Day 1",true,"FEMALE","16 Years","30 Years",{"count":395,"type":396},4580,"ESTIMATED","INTERVENTIONAL",[399],"PHASE3","Researchers are looking for new medicines to prevent HIV-1 (Human Immunodeficiency Virus Type 1) infection.\n\nThe goals of this study are to learn:\n\n* If taking MK-8527 once a month works to prevent HIV-1 infection better than a standard (usual) pre-exposure prophylaxis (PrEP) taken once a day\n* About the safety of MK-8527 and if people tolerate it",[402,403],"Human Immunodeficiency Virus (HIV)","HIV Pre-Exposure Prophylaxis","2026-06-26",{"date":406,"type":407},"2026-06-29","ACTUAL",{"date":409,"type":407},"2025-11-10",{"date":411,"type":396},"2027-10-18",{"name":5,"class":6},30]