[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645068":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":36,"locations":46,"responsibleParty":66,"collaborators":41,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":41,"enrollmentInfo":78,"targetDuration":41,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":89,"overallStatus":49,"whyStopped":41,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Instituto Mexicano del Seguro Social","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Dual therapy: darunavir\u002Fcobicistat + lamivudine","ACTIVE_COMPARATOR","Darunavir\u002Fcobicistat 800\u002F150 mg + lamivudine 300 mg. This arm is the active comparator one, with dual therapy, 2 drugs: darunavir\u002Fcobicistat 800\u002F150 mg plus lamivudine 300 mg",[13],"Drug: Dual therapy: darunavir\u002Fcobicistat + lamivudine",{"label":15,"type":16,"description":17,"interventionNames":18},"Triple therapy: darunavir\u002Fcobicistat plus tenofovir alafenamide\u002Femtricitabine","EXPERIMENTAL","Darunavir\u002Fcobicistat 800\u002F150 mg + tenofovir alafenamide\u002Femtricitabine 10\u002F200 mg. This treatment is the commonly used or standard 3-drug therapy, this arm is the active comparator one consisting of darunavir\u002Fcobicistat 800\u002F150 mg, plus tenofovir alafenamide\u002Femtricitabine 10\u002F200 mg.",[19],"Drug: Triple therapy: darunavir\u002Fcobicistat plus tenofovir alafenamide\u002Femtricitabine",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","The intervention group will receive dual therapy with DRV\u002FC 800\u002F150 mg + 3TC 300 mg, which will be compared to standard 3-drug therapy: DRV\u002FC 800\u002F150 mg + TAF\u002FFTC 10\u002F200 mg.",[9],[26],"DRV\u002FC+3TC",{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":30},"The intervention group will receive triple therapy: DRV\u002FC 800\u002F150 mg + TAF\u002FFTC 10\u002F200 mg.which will be compared to dual therapy with DRV\u002FC 800\u002F150 mg + 3TC 300 mg.",[15],[31],"DRV\u002Fc+TAF\u002FFTC",[33],{"name":34,"affiliation":5,"role":35},"Sandra Patricia Ramírez Eguia","PRINCIPAL_INVESTIGATOR",[37,43],{"name":38,"role":39,"phone":40,"phoneExt":41,"email":42},"José Antonio Mata Marín, Master","CONTACT","+524428518215",null,"sandrarmzeg@gmail.com",{"name":44,"role":39,"phone":45,"phoneExt":41,"email":42},"Jóse Antonio Mata Marin, Master","4428518215",[47],{"facility":48,"status":49,"city":50,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Hospital de Infectología \"Dr Daniel Méndez Hernández\" National Medical Center \"La Raza\", Instituto Mexicano del Seguro Social","RECRUITING","Mexico City","02990","Mexico","MX",{"type":55,"coordinates":56},"Point",[57,58],-99.12766,19.42847,{"lat":58,"lon":57},[61,63,65],{"name":62,"role":39,"phone":45,"phoneExt":41,"email":42},"Jóse Antonio Mata Marin",{"name":64,"role":39,"phone":45,"phoneExt":41,"email":42},"Jóse Antonio Mata Marín",{"name":34,"role":35,"phone":41,"phoneExt":41,"email":41},{"type":35,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"José Antonio Mata Marín","Effectiveness and safety of darunavir\u002Fcobicistat plus lamivudine compared with darunavir\u002Fcobicistat plus tenofovir alafenamide\u002Femtricitabine in virologically suppressed people living with HIV at 24 and 48 weeks of follow-up","100645068","phase-4-effectiveness-and-safety-of-darunavircobicistat-plus-lamivudine-compared-with-darunavircobicistat-plus-tenofovir-alafenamideemtricitabine-in-virologically-suppressed-people-living-with-hiv-at-24-and-48-weeks-of-follow-up-100645068",false,"NCT07678268","Effectiveness and Safety of Darunavir\u002FCobicistat Plus Lamivudine Compared With Darunavir\u002FCobicistat Plus Tenofovir Alafenamide\u002FEmtricitabine in Virologically Suppressed People Living With HIV at 24 and 48 Weeks of Follow-up","TLALOC-2","Inclusion Criteria:\n\n* Virologically suppressed men living with HIV, transitioning from a DRV\u002Fc (800 mg\u002F150 mg) + TDF\u002FFTC (300 mg\u002F200 mg) regimen for at least 48 weeks prior to the study\n* Viral suppression for 48 weeks prior to the study\n* Agree to participate in the study by signing a written informed consent form\n* Age ≥18 years\n* Glomerular filtration rate (GFR) by CDK-EPI ≥60 mL\u002Fmin\n* Beneficiaries of the Mexican Social Security Institute (IMSS) treated at the Infectious Diseases Hospital of the \"La Raza\" National Medical Center\n\nExclusion Criteria:\n\n* Withdrawal of informed consent\n* Loss of coverage\n* Failure to attend sample collection within the required timeframe","MALE","18 Years",{"count":79,"type":80},78,"ESTIMATED","INTERVENTIONAL",[83],"PHASE4","A single-center, open-label, randomized pilot clinical trial between March 2025 and March 2026 at the Hospital de Infectología \"La Raza\" National Medical Center in Mexico City. Eligible participants were adult males (≥18 years) with HIV-1 infection who had maintained virological suppression (HIV-1 RNA \\\u003C50 copies\u002FmL) for 48 weeks on either DRV\u002Fc + 3TC or DRV\u002Fc + TDF\u002FFTC prior to enrollment (TLALOC-1 trial), and had an estimated glomerular filtration rate (eGFR) by CKD-EPI ≥60 mL\u002Fmin\u002F1.73 m². The primary endpoints were virological efficacy and safety at 24 weeks.",[86,87,88],"HIV Infection","Antiretroviral Therapy","Lentivirus Infections",[90,91,92,93,94],"HIV infection","antiretroviral therapy","two drugs regimen","renal safety","neuropsychiatric adverse events","2026-06-25",{"date":97,"type":98},"2026-07-01","ACTUAL",{"date":100,"type":98},"2025-07-10",{"date":102,"type":80},"2026-12-10",{"name":5,"class":6},1]