[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553366":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":37,"responsibleParty":117,"collaborators":120,"id":123,"slug":124,"hasResults":125,"nctId":126,"briefTitle":127,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":125,"sex":130,"minAge":131,"maxAge":31,"enrollmentInfo":132,"targetDuration":31,"studyType":135,"phases":136,"briefSummary":138,"conditions":139,"keywords":141,"overallStatus":39,"whyStopped":31,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":154},{"fullName":5,"class":6},"University of Witwatersrand, South Africa","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"TLD - Tenofovir Disoproxil Fumarate \u002F Lamivudine \u002F Dolutegravir","EXPERIMENTAL","The IMP is defined as any investigational marketed product to be administered to a study participant according to the study protocol.\n\nParticipants will all receive TLD as detailed below. Treatment will be open-label, and drugs will be dispensed at intervals as specified in the Schedule of Events.\n\nInvestigational Product Tenofovir disoproxil fumarate \u002F lamivudine \u002F dolutegravir Dosage Formulation 300 mg \u002F 300 mg \u002F 50 mg fixed dose combination tablet Route of Administration Oral Dosing Instructions 1 tablet (300\u002F300\u002F50 mg TDF\u002F3TC\u002FDTG) daily",[13],"Drug: TLD - Tenofovir Disoproxil Fumarate \u002F Lamivudine \u002F Dolutegravir",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Dolutegravir, lamivudine and tenofovir disoproxil fumarate tablets, a combination of dolutegravir (integrase strand transfer inhibitor \\[INSTI\\]), lamivudine, and tenofovir disoproxil fumarate (both nucleoside reverse transcriptase inhibitors), is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg",[9],[20],"Acriptega",[22],{"name":23,"affiliation":24,"role":25},"FRANCOIS WD VENTER, PhD","Ezintsha, a division of Wits Health Consortium","STUDY_DIRECTOR",[27,33],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},"BUKANI X DYARIWE","CONTACT","0110844961",null,"bdyariwe@ezintsha.org",{"name":34,"role":29,"phone":35,"phoneExt":31,"email":36},"SIMISO M SOKHELA, MBChB","0110844933","ssokhela@ezintsha.org",[38,70,95],{"facility":24,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"RECRUITING","Johannesburg","Gauteng","2193","South Africa","ZA",{"type":46,"coordinates":47},"Point",[48,49],28.04363,-26.20227,{"lat":49,"lon":48},[52,56,57,59,62,64,66,68],{"name":53,"role":29,"phone":54,"phoneExt":31,"email":55},"NONKULULEKO MASHABANE, BPharm","0110844953","nmashabane@ezintsha.org",{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},{"name":34,"role":58,"phone":31,"phoneExt":31,"email":31},"PRINCIPAL_INVESTIGATOR",{"name":60,"role":61,"phone":31,"phoneExt":31,"email":31},"JOANA F WOODS, MBChB","SUB_INVESTIGATOR",{"name":63,"role":61,"phone":31,"phoneExt":31,"email":31},"ESTHER S BHASKAR, MBChB",{"name":65,"role":61,"phone":31,"phoneExt":31,"email":31},"NCOMEKA MANENTSA, MBChB",{"name":67,"role":61,"phone":31,"phoneExt":31,"email":31},"KARLIEN MOLLER, MBChB",{"name":69,"role":61,"phone":31,"phoneExt":31,"email":31},"EMEMABASI EDEM, MBChB",{"facility":71,"status":39,"city":72,"state":73,"zip":74,"country":43,"countryCode":44,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"Africa Health Research Institute (AHRI)","Durban","KwaZulu-Natal","3935",{"type":46,"coordinates":76},[77,78],31.0292,-29.8579,{"lat":78,"lon":77},[81,85,87,89,91,93],{"name":82,"role":29,"phone":83,"phoneExt":31,"email":84},"MARK SIEDNER, MBBCh","035 251 0650","mark.siedner@ahri.org",{"name":86,"role":29,"phone":83,"phoneExt":31,"email":31},"LIMAKATSO LEBINA, MBBCh",{"name":88,"role":58,"phone":31,"phoneExt":31,"email":31},"MARYAM SHAHMANESH, PHD",{"name":90,"role":61,"phone":31,"phoneExt":31,"email":31},"LIMAKATSO LEBINA, MBChB",{"name":92,"role":61,"phone":31,"phoneExt":31,"email":31},"MARK SIEDNER, MPH",{"name":94,"role":61,"phone":31,"phoneExt":31,"email":31},"NTSIKA FILEYO, MBChB",{"facility":96,"status":39,"city":97,"state":98,"zip":99,"country":43,"countryCode":44,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"Desmond Tutu Health Foundation","Cape Town","Western Cape","7925",{"type":46,"coordinates":101},[102,103],18.42322,-33.92584,{"lat":103,"lon":102},[106,110,113,115],{"name":107,"role":29,"phone":108,"phoneExt":31,"email":109},"ELZETTE Rousseau, PHD","021 301 2020","Elzette.Rousseau@hiv-research.org.za",{"name":111,"role":29,"phone":108,"phoneExt":31,"email":112},"LINDA-GAIL BEKKER, MB","Linda-Gail.Bekker@hiv-research.org.za",{"name":114,"role":58,"phone":31,"phoneExt":31,"email":31},"LINDA-GAIL BEKKER, MBChB",{"name":116,"role":61,"phone":31,"phoneExt":31,"email":31},"PIPPA MACDONALD, MBChB",{"type":58,"investigatorFullName":118,"investigatorTitle":119,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Professor Francois Venter","Executive Director: Ezintsha",[121],{"name":122,"class":6},"Bill and Melinda Gates Foundation","100553366","phase-4-post-injectable-cabotegravir-antiretroviral-salvage-strategy-options-trial-100553366",false,"NCT06485154","Post-Injectable Cabotegravir Antiretroviral Salvage Strategy Options Trial","PICASSO","Inclusion Criteria:\n\n1. Male or female.\n2. Age ≥ 15 years, inclusive, at the time of signing the informed consent.\n3. Body weight ≥ 35 kg.\n4. Confirmed HIV-1 infection.\n5. Exposure to at least one dose of CAB-LA PrEP in the past 12 months.\n6. Consent to initiation of ART.\n7. Estimated glomerular filtration rate (eGFR) \\> 50 min\u002FmL\n\nExclusion Criteria:\n\n1. Any previous exposure to DTG.\n2. Concurrent or recent (within the preceding 3 months) participation in another interventional clinical trial with a compound likely to interfere with any of the investigational medicinal products.\n3. Known hypersensitivity or specific contraindications to the use of any of the active drugs in the treatment arms or similar compounds.\n4. Is receiving or has received the following agents within 28 days prior to screening, and cannot discontinue their use for the duration of the study:\n\n   1. tuberculosis therapy (i.e., rifampicin, rifapentine, rifabutin), with the exception of isoniazid (INH) prevention therapy;\n   2. anti-convulsants (e.g., carbamazepine, oxcarbazepine, phenobarbital, phenytoin);\n   3. herbal products (e.g., St John's Wort).\n5. Any surgical or medical condition which may significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the safety of the volunteer or the objectives of the study or impair their ability to comply with the dosing schedule and\u002For protocol evaluations. The Investigator should make this determination in consideration of the volunteer's medical history.\n6. Participant is judged by the Investigator to be at significant risk of failing to comply with the provisions of the protocol as to cause harm to self or seriously interfere with the validity of the study results. This including inability or an unwillingness to be followed up for the study period.","ALL","15 Years",{"count":133,"type":134},100,"ESTIMATED","INTERVENTIONAL",[137],"PHASE4","This is a single-arm, open-label, effectiveness study designed to evaluate the use of Tenofovir, Lamivudine, and Dolutegravir in people with newly diagnosed HIV-1 infection initiating first-line Antiretroviral Therapy with Cabotegravir-Long-acting Pre-Exposure Prophylaxis exposure in the preceding 12 months. Participants will be followed up for a period of 12 months from enrolment.",[140],"HIV Prevention",[142,143,144],"Pre-Exposure Prophylaxis (PrEP)","Antiretroviral therapy","Tenofovir Disoproxil Fumarate\u002FLamivudine\u002FDolutegravir","2026-06-04",{"date":147,"type":148},"2026-06-09","ACTUAL",{"date":150,"type":148},"2024-06-01",{"date":152,"type":134},"2026-08-31",{"name":5,"class":6},3]