[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629566":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":23,"centralContacts":30,"locations":42,"responsibleParty":201,"collaborators":203,"id":210,"slug":211,"hasResults":212,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":216,"eligibilityCriteria":217,"healthyVolunteers":212,"sex":218,"minAge":219,"maxAge":40,"enrollmentInfo":220,"targetDuration":40,"studyType":223,"phases":224,"briefSummary":226,"conditions":227,"keywords":232,"overallStatus":247,"whyStopped":40,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":257},{"fullName":5,"class":6},"CAN Community Health","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Open-label B\u002FF\u002FTAF","EXPERIMENTAL","All participants receive open-label B\u002FF\u002FTAF. Treatment duration is determined by baseline viral load: viremic participants (defined by HIV-1 RNA ≥50 copies\u002FmL) at baseline will receive 48 weeks of B\u002FF\u002FTAF; virologically suppressed participants (defined by HIV-1 RNA \\\u003C50 copies\u002FmL) at baseline will receive 24 weeks of B\u002FF\u002FTAF.",[13],"Drug: Bictegravir, emtricitabine, and tenofovir alafenamide",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Bictegravir, emtricitabine, and tenofovir alafenamide","Oral, film-coated tablet containing 50 mg BIC, 200 mg FTC, and 25 mg TAF taken once daily with or without food administered for 24 or 48 weeks.",[9],[21,22],"B\u002FF\u002FTAF","BIKTARVY®",[24,27],{"name":25,"affiliation":5,"role":26},"Jessica Altamirano, MD","PRINCIPAL_INVESTIGATOR",{"name":28,"affiliation":29,"role":26},"Hector Bolivar, MD","Midway Specialty Care Center",[31,37],{"name":32,"role":33,"phone":34,"phoneExt":35,"email":36},"Prerak Shukla, MD","CONTACT","941-366-0134","11102","pshukla@cancommunityhealth.org",{"name":38,"role":33,"phone":39,"phoneExt":40,"email":41},"Miranda Townsend","+44 7709-514-696",null,"biktarvy.rapidrestartstudy@costellomedical.com",[43,65,85,100,115,129,144,159,171,185],{"facility":5,"status":40,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Clearwater","Florida","33765","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-82.8001,27.96585,{"lat":53,"lon":52},[56,59,63],{"name":25,"role":33,"phone":57,"phoneExt":40,"email":58},"786-800-5631","jaltamirano@cancommunityhealth.org",{"name":60,"role":33,"phone":61,"phoneExt":40,"email":62},"Jeanette Cancel, MD","727-216-6193","jcancel@cancommunityhealth.org",{"name":60,"role":64,"phone":40,"phoneExt":40,"email":40},"SUB_INVESTIGATOR",{"facility":29,"status":40,"city":66,"state":45,"zip":67,"country":47,"countryCode":48,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Ft. Pierce","34982",{"type":50,"coordinates":69},[70,71],-80.32561,27.44671,{"lat":71,"lon":70},[74,77,81,83],{"name":28,"role":33,"phone":75,"phoneExt":40,"email":76},"561-249-2279","drbolivar@midwaycare.org",{"name":78,"role":33,"phone":79,"phoneExt":40,"email":80},"Jenn L Kuretski, DNP, APRN, NP-C,AAHIVS","772-464-9746","Jkuretski@midwaycare.org",{"name":82,"role":64,"phone":40,"phoneExt":40,"email":40},"Moti Ramgopal, MD",{"name":84,"role":64,"phone":40,"phoneExt":40,"email":40},"Angela Trodglen, APRN",{"facility":5,"status":40,"city":86,"state":45,"zip":87,"country":47,"countryCode":48,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"Jacksonville","32207",{"type":50,"coordinates":89},[90,91],-81.65565,30.33218,{"lat":91,"lon":90},[94,95,99],{"name":25,"role":33,"phone":57,"phoneExt":40,"email":58},{"name":96,"role":33,"phone":97,"phoneExt":40,"email":98},"Katherine Rogers, APRN","904-508-0701","krogers@cancommunityhealth.org",{"name":96,"role":64,"phone":40,"phoneExt":40,"email":40},{"facility":5,"status":40,"city":101,"state":45,"zip":102,"country":47,"countryCode":48,"cosmosGeoPoint":103,"geoPoint":107,"contacts":108},"Orlando","32804",{"type":50,"coordinates":104},[105,106],-81.37924,28.53834,{"lat":106,"lon":105},[109,110,114],{"name":25,"role":33,"phone":57,"phoneExt":40,"email":58},{"name":111,"role":33,"phone":112,"phoneExt":40,"email":113},"Vincenzo Scotto D'Antuono, MD","407-246-1946","vsdantuono@cancommunityhealth.org",{"name":111,"role":64,"phone":40,"phoneExt":40,"email":40},{"facility":29,"status":40,"city":101,"state":45,"zip":116,"country":47,"countryCode":48,"cosmosGeoPoint":117,"geoPoint":119,"contacts":120},"32819",{"type":50,"coordinates":118},[105,106],{"lat":106,"lon":105},[121,122,125,127],{"name":28,"role":33,"phone":75,"phoneExt":40,"email":76},{"name":123,"role":33,"phone":124,"phoneExt":40,"email":80},"Jenn L Kuretski, DNP, APRN, NP-C, AAHIVS","407-745-1171",{"name":126,"role":64,"phone":40,"phoneExt":40,"email":40},"Emmanuelle Allseits, MD",{"name":128,"role":64,"phone":40,"phoneExt":40,"email":40},"Aylin Perez, PA",{"facility":5,"status":40,"city":130,"state":45,"zip":131,"country":47,"countryCode":48,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"Tampa","33602",{"type":50,"coordinates":133},[134,135],-82.45843,27.94752,{"lat":135,"lon":134},[138,139,143],{"name":25,"role":33,"phone":57,"phoneExt":40,"email":58},{"name":140,"role":33,"phone":141,"phoneExt":40,"email":142},"Elier Rodriguez, MD","941-300-4440","erodriguez@cancommunityhealth.org",{"name":140,"role":64,"phone":40,"phoneExt":40,"email":40},{"facility":29,"status":40,"city":145,"state":45,"zip":146,"country":47,"countryCode":48,"cosmosGeoPoint":147,"geoPoint":151,"contacts":152},"Temple Terrace","33617",{"type":50,"coordinates":148},[149,150],-82.38926,28.0353,{"lat":150,"lon":149},[153,155,157],{"name":154,"role":33,"phone":75,"phoneExt":40,"email":76},"Hector Hector, MD",{"name":123,"role":33,"phone":156,"phoneExt":40,"email":80},"813-733-8224",{"name":158,"role":64,"phone":40,"phoneExt":40,"email":40},"Rodrigo Sabec, APRN",{"facility":29,"status":40,"city":160,"state":45,"zip":161,"country":47,"countryCode":48,"cosmosGeoPoint":162,"geoPoint":166,"contacts":167},"West Palm Beach","33409",{"type":50,"coordinates":163},[164,165],-80.05337,26.71534,{"lat":165,"lon":164},[168,169,170],{"name":28,"role":33,"phone":75,"phoneExt":40,"email":76},{"name":123,"role":33,"phone":75,"phoneExt":40,"email":80},{"name":123,"role":64,"phone":40,"phoneExt":40,"email":40},{"facility":29,"status":40,"city":172,"state":45,"zip":173,"country":47,"countryCode":48,"cosmosGeoPoint":174,"geoPoint":178,"contacts":179},"Wilton Manors","33334",{"type":50,"coordinates":175},[176,177],-80.13893,26.16036,{"lat":177,"lon":176},[180,181,183],{"name":28,"role":33,"phone":75,"phoneExt":40,"email":76},{"name":123,"role":33,"phone":182,"phoneExt":40,"email":80},"954-530-8357",{"name":184,"role":64,"phone":40,"phoneExt":40,"email":40},"Isabel Gomez, MD",{"facility":5,"status":40,"city":186,"state":187,"zip":188,"country":47,"countryCode":48,"cosmosGeoPoint":189,"geoPoint":193,"contacts":194},"Las Vegas","Nevada","89104",{"type":50,"coordinates":190},[191,192],-115.13722,36.17497,{"lat":192,"lon":191},[195,196,200],{"name":25,"role":33,"phone":57,"phoneExt":40,"email":58},{"name":197,"role":33,"phone":198,"phoneExt":40,"email":199},"Archer Grimley, MD","702-979-1111","archgrimley@cancommunityhealth.org",{"name":197,"role":64,"phone":40,"phoneExt":40,"email":40},{"type":202,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR",[204,207,208],{"name":205,"class":206},"Gilead Sciences","INDUSTRY",{"name":29,"class":6},{"name":209,"class":6},"Costello Medical Inc.","100629566","phase-4-reinitiation-of-antiretroviral-therapy-using-oral-bictegravir-emtricitabine-and-tenofovir-alafenamide-100629566",false,"NCT07476339","REINItiation of Antiretroviral Therapy Using Oral bicTegravir, emtrIcitAbine and Tenofovir alafenamidE","A Multi-Center, Single-Arm, Open-Label, Prospective, Phase 4 Study to Investigate the Safety and Efficacy of Rapidly Restarting Oral Bictegravir, Emtricitabine, and Tenofovir Alafenamide (B\u002FF\u002FTAF) in Viremic and Virologically-Suppressed Male and Female HIV-Positive Patients Aged ≥18 Years Who Are Treatment-Experienced and Returning to Care After Experiencing a Treatment Interruption of ≥12 Weeks","REINITIATE","Inclusion Criteria:\n\n* ≥18 years of age at the time of signing the informed consent form (ICF)\n* Diagnosis of HIV-1 confirmed by any positive HIV 4th generation test or detectable HIV-1 RNA level in \\>6 months\n* Previously received ART for ≥30 consecutive days, as self-reported\n* No ART dose received for ≥12 weeks prior to provision of informed consent, by any route of administration (i.e., injection or oral), as self-reported\n* Returning to care with an interest to restart ART therapy\n* Body weight ≥25 kg\n* Signed ICF which includes compliance with the requirements and restrictions listed in ICF and study protocol\n\nExclusion Criteria:\n\n* Diagnosis of HIV-2 infection\n* Known or suspected history of severe hepatic impairment (Child-Pugh Class C)\n* Known or suspected history of severe renal impairment (estimated creatinine clearance \\[eCrCl\\] \\\u003C30 mL\u002Fmin)\n* Concomitant medication that is contraindicated with B\u002FF\u002FTAF\n* Known or suspected resistance to BIC (resistance-associated mutations (RAMs) include: T66A\u002FI\u002FK, E92G\u002FQ, G118R, F121Y, Y143C\u002FH\u002FR, S147G, Q148H\u002FK\u002FR, N155H\u002FS, or R263K in the integrase gene)\n* Known\u002Fsuspected resistance to TFV (RAMs include: K65R\u002FE\u002FN, or K70E)\n* Known\u002Fsuspected history of 3 or more TAMs (M41L, D67N, K70R, L210W, T215F\u002FY, and K219Q\u002FE\u002FN\u002FR), T69-insertions, or K65R\u002FE\u002FN in RT\n* History of B\u002FF\u002FTAF intolerance\n* Unable to swallow whole tablets or swallow tablets cut into halves\n* Unable to communicate in either English or Spanish","ALL","18 Years",{"count":221,"type":222},200,"ESTIMATED","INTERVENTIONAL",[225],"PHASE4","Managing HIV well requires taking antiretroviral therapy (ART) every day, but many people living with HIV experience interruptions in their treatment. These pauses in medication can happen for many reasons, such as side effects, challenges with getting to the clinic, personal circumstances, stigma, or difficulties with everyday life. When HIV treatment is stopped, the viral load can increase, which may affect a person's health and make it easier for HIV to be passed on to others. Restarting treatment quickly after an interruption is important for both personal and public health. However, it can be difficult for people who miss doses to get back on treatment right away. There are often several steps and medical appointments required before restarting, such as waiting for lab results or reviewing medical history, which can cause further delays. These additional steps can make it even harder for people to re-engage and may discourage them from returning to care.\n\nThe REINITIATE study is designed for people living with HIV who have not taken any antiretroviral medications for at least the last 12 weeks. The study will offer participants a way to restart their HIV therapy quickly, by beginning treatment with B\u002FF\u002FTAF on the same day that they return to care. B\u002FF\u002FTAF is a widely used, once-daily HIV regimen, and is recommended in national treatment guidelines.\n\nResearchers want to find out if this rapid restart approach is safe and effective, and whether it helps people regain control of HIV and remain in care. The study will also examine how many participants are able to keep the virus at a low level (viral suppression), stay engaged in their HIV care, and tolerate the medication after rapidly restarting treatment. In addition, the study will include interviews with some participants, to gain a better understanding of why they stopped taking their medications and what supported their return to treatment. These insights could help healthcare teams develop better ways to support people living with HIV in the future.",[228,229,230,231],"HIV -1 Infection","HIV (Human Immunodeficiency Virus)","HIV","HIV 1 Infection",[233,234,235,236,237,238,239,240,241,242,243,244,21,245,246],"HIV-1","HIV Infections","Bictegravir","Emtricitabine","Tenofovir Alafenamide","Antiretroviral Therapy","Antiretroviral Therapy, Highly Active","Treatment Interruption","Virologically Suppressed","Treatment-Experienced","Returning to Care","Phase 4","B\u002FF\u002FTAF; bictegravir, emtricitabine, tenofovir alafenamide, drug combination","Rapid Restart","NOT_YET_RECRUITING","2026-03-26",{"date":250,"type":251},"2026-03-31","ACTUAL",{"date":253,"type":222},"2026-03-23",{"date":255,"type":222},"2026-10-23",{"name":5,"class":6},10]