[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100523870":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":44,"centralContacts":48,"locations":49,"responsibleParty":157,"collaborators":159,"id":163,"slug":164,"hasResults":165,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":169,"eligibilityCriteria":170,"healthyVolunteers":171,"sex":172,"minAge":173,"maxAge":48,"enrollmentInfo":174,"targetDuration":48,"studyType":177,"phases":178,"briefSummary":180,"conditions":181,"keywords":48,"overallStatus":183,"whyStopped":48,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":192,"locationsCount":193},{"fullName":5,"class":6},"Gilead Sciences","INDUSTRY",[8,15,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Randomized Phase: Lenacapavir (LEN) Group","EXPERIMENTAL","Participants will receive subcutaneous (SC) lenacapavir (LEN) 927 mg on Day 1 and Week 26 and oral LEN 600 mg on Days 1 and 2.",[13,14],"Drug: Lenacapavir Tablet","Drug: Lenacapavir Injection",{"label":16,"type":10,"description":17,"interventionNames":18},"Randomized Phase: Emtricitabine\u002FTenofovir Disoproxil Fumarate (F\u002FTDF) Group","Participants will receive oral F\u002FTDF (200\u002F300 mg) daily for 52 weeks.",[19],"Drug: Emtricitabine\u002FTenofovir Disoproxil Fumarate (F\u002FTDF)",{"label":21,"type":10,"description":22,"interventionNames":23},"PK Tail Phase: F\u002FTDF","After the completion of the Randomized Phase, participants in LEN group will be transitioned to receive F\u002FTDF and participants in F\u002FTDF group will continue to receive F\u002FTDF in the PK Tail Phase. All participants will receive F\u002FTDF, once daily for 78 weeks beginning 26 weeks after the last LEN injection.",[19],[25,32,38],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Lenacapavir Tablet","Tablets administered orally without regard of food",[9],[31],"GS-6207",{"type":26,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"Lenacapavir Injection","Injection administered subcutaneously",[9],[31,37],"Yeztugo®",{"type":26,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"Emtricitabine\u002FTenofovir Disoproxil Fumarate (F\u002FTDF)","200\u002F300mg fixed dose combination (FDC) tablets administered orally",[21,16],[43],"Truvada®",[45],{"name":46,"affiliation":5,"role":47},"Gilead Study Director","STUDY_DIRECTOR",null,[50,63,73,83,93,103,113,122,128,137,147],{"facility":51,"status":48,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":48},"UAB, 1917 Research Clinic","Birmingham","Alabama","35222","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-86.80249,33.52066,{"lat":61,"lon":60},{"facility":64,"status":48,"city":65,"state":66,"zip":67,"country":55,"countryCode":56,"cosmosGeoPoint":68,"geoPoint":72,"contacts":48},"UCSD Antiviral Research Center (AVRC)","San Diego","California","92103",{"type":58,"coordinates":69},[70,71],-117.16472,32.71571,{"lat":71,"lon":70},{"facility":74,"status":48,"city":75,"state":76,"zip":77,"country":55,"countryCode":56,"cosmosGeoPoint":78,"geoPoint":82,"contacts":48},"George Washington University Medical Faculty Associates","Washington D.C.","District of Columbia","20037",{"type":58,"coordinates":79},[80,81],-77.03637,38.89511,{"lat":81,"lon":80},{"facility":84,"status":48,"city":85,"state":86,"zip":87,"country":55,"countryCode":56,"cosmosGeoPoint":88,"geoPoint":92,"contacts":48},"Ponce de Leon Center Clinical Research Site","Atlanta","Georgia","30303",{"type":58,"coordinates":89},[90,91],-84.38798,33.749,{"lat":91,"lon":90},{"facility":94,"status":48,"city":95,"state":96,"zip":97,"country":55,"countryCode":56,"cosmosGeoPoint":98,"geoPoint":102,"contacts":48},"Fenway Health","Boston","Massachusetts","02215",{"type":58,"coordinates":99},[100,101],-71.05977,42.35843,{"lat":101,"lon":100},{"facility":104,"status":48,"city":105,"state":106,"zip":107,"country":55,"countryCode":56,"cosmosGeoPoint":108,"geoPoint":112,"contacts":48},"Rutgers New Jesey Medical School - Clinical Research Center","Newark","New Jersey","07103",{"type":58,"coordinates":109},[110,111],-74.17237,40.73566,{"lat":111,"lon":110},{"facility":114,"status":48,"city":115,"state":115,"zip":116,"country":55,"countryCode":56,"cosmosGeoPoint":117,"geoPoint":121,"contacts":48},"Cornell Clinical Trials Unit, New York Presbyterian Hospital - Weill Cornell Medicine","New York","10010",{"type":58,"coordinates":118},[119,120],-74.00597,40.71427,{"lat":120,"lon":119},{"facility":123,"status":48,"city":115,"state":115,"zip":124,"country":55,"countryCode":56,"cosmosGeoPoint":125,"geoPoint":127,"contacts":48},"Harlem Prevention Center CRS","10027",{"type":58,"coordinates":126},[119,120],{"lat":120,"lon":119},{"facility":129,"status":48,"city":130,"state":115,"zip":131,"country":55,"countryCode":56,"cosmosGeoPoint":132,"geoPoint":136,"contacts":48},"ICAP at Columbia University - Bronx Prevention Center","The Bronx","10451",{"type":58,"coordinates":133},[134,135],-73.86641,40.84985,{"lat":135,"lon":134},{"facility":138,"status":48,"city":139,"state":140,"zip":141,"country":55,"countryCode":56,"cosmosGeoPoint":142,"geoPoint":146,"contacts":48},"NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill","Chapel Hill","North Carolina","27599",{"type":58,"coordinates":143},[144,145],-79.05584,35.9132,{"lat":145,"lon":144},{"facility":148,"status":48,"city":149,"state":150,"zip":151,"country":55,"countryCode":56,"cosmosGeoPoint":152,"geoPoint":156,"contacts":48},"Penn Prevention Research Unit","Philadelphia","Pennsylvania","19104",{"type":58,"coordinates":153},[154,155],-75.16362,39.95238,{"lat":155,"lon":154},{"type":158,"investigatorFullName":48,"investigatorTitle":48,"investigatorAffiliation":48,"oldNameTitle":48,"oldOrganization":48},"SPONSOR",[160],{"name":161,"class":162},"HIV Prevention Trials Network","NETWORK","100523870","phase-2-study-of-lenacapavir-and-emtricitabinetenofovir-disoproxil-fumarate-ftdf-in-prevention-of-hiv-in-cisgender-women-in-the-united-states-hptn-102-100523870",false,"NCT06101329","Study of Lenacapavir and Emtricitabine\u002FTenofovir Disoproxil Fumarate (F\u002FTDF) in Prevention of HIV in Cisgender Women in the United States (HPTN 102)","A Phase 2, Open-label, Multicenter, Randomized Study to Evaluate the Pharmacokinetics, Safety, and Acceptability of Twice Yearly Long-acting Subcutaneous Lenacapavir for Pre-Exposure Prophylaxis in Cisgender Women in the United States","PURPOSE 3","Key Inclusion Criteria:\n\n* Report at least 1 episode of condomless vaginal or anal sex with a cisgender man in the 12 months before enrollment.\n* Hepatitis B virus (HBV) surface antigen (HBsAg) negative.\n* Self-report one or more of the following in the past 12 months (except for incarceration, which could have occurred in the past 5 years):\n\n  1\\) Noninjection recreational drug use (ecstasy, cocaine, crack cocaine, methamphetamine, ketamine, 3,4-methylenedioxy-methamphetamine, or prescription drugs apart from those prescribed by a licensed provider); 2) Alcohol dependence (defined as Cut Down, Annoyed, Guilty, and Eye Opener score of 2); binge-drinking, defined as 4 or more drinks at a time; 3) History of STIs, such as gonorrhea, chlamydia, or syphilis; 4) Exchange of sex for commodities, such as drugs, money, or shelter; 5) Incarceration (jail or prison \\> 24 hours within the past 5 years); 6) Two or more sexual partners who were assigned male at birth; 7) Sexual partner assigned male at birth with history of either injection or noninjection recreational drug use, sexually transmitted infections (STIs), human immunodeficiency virus (HIV) diagnosis or unknown HIV status, additional sex partners during the course of his sexual relationship with the individual, or incarceration (jail or prison \\> 24 hours within the past 5 years)\n* Negative local rapid HIV-1\u002F2 antibody (Ab)\u002Fantigen (Ag) test, central HIV-1\u002F2 Ab\u002FAg, and HIV-1 RNA quantitative nucleic acid amplification testing (NAAT).\n* Estimated glomerular filtration rate (GFR) at least 60 mL\u002Fmin at screening according to the Cockcroft-Gault formula for creatinine clearance (CLcr).\n\nKey Exclusion Criteria:\n\n* Self-reported history of previous positive results on an HIV test.\n* One or more reactive or positive HIV test result at screening or enrollment, even if HIV infection is not confirmed.\n* Past or current participation in HIV vaccine or HIV broadly neutralizing antibody study unless individual provides documentation of receipt of placebo (ie, not active product).\n* Prior use of long-acting systemic pre-exposure prophylaxis (PrEP) (including cabotegravir (CAB) or islatravir studies).\n* Acute viral hepatitis A or acute or chronic hepatitis B or C infection.\n* Severe hepatic impairment or a history of or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, variceal bleeding, etc).\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",true,"FEMALE","18 Years",{"count":175,"type":176},253,"ACTUAL","INTERVENTIONAL",[179],"PHASE2","The goal of this clinical study is to look at how lenacapavir (LEN) passes through the body and to assess the safety of LEN and emtricitabine\u002Ftenofovir disoproxil fumarate (F\u002FTDF) for prevention of HIV in the cisgender women in the US.\n\nThe primary objectives of this study are: 1) to characterize the pharmacokinetics (PK) of LEN in United States (US) cisgender women; 2) to evaluate the safety of LEN and F\u002FTDF for pre-exposure prophylaxis (PrEP) in US cisgender women; and 3) to evaluate the general acceptability of LEN injections and oral F\u002FTDF in US cisgender women.",[182],"Pre-Exposure Prophylaxis of HIV Infection","ACTIVE_NOT_RECRUITING","2026-08-14",{"date":186,"type":176},"2026-08-17",{"date":188,"type":176},"2023-11-17",{"date":190,"type":191},"2028-01","ESTIMATED",{"name":5,"class":6},11]