[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603563":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":33,"locations":34,"responsibleParty":58,"collaborators":33,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":33,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":37,"whyStopped":33,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Instituto Mexicano del Seguro Social","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standar therapy","ACTIVE_COMPARATOR","Bictegravir 50 mg \u002F tenofovir alafenamide 25 mg \u002F emtricitabine 200 mg or dolutegravir 50 mg \u002F lamivudine 300 mg \u002F abacavir 600 mg, both combinations in a single tablet, will be used as standard therapy",[13],"Drug: Standard Medical Therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"dual therapy","EXPERIMENTAL","This arm is the experimental one, with dual therapy, 2 drugs: Dolutegravir 50 mg\u002FLamivudina 300 mg, in a single tablet.",[19],"Drug: dual therapy",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Standard Medical Therapy","Intervention arm will be dual therapy oh DTG 50 mg\u002F 3TC 300 mg, this will be compared to standar therapy of 3 drugs with: Bictegravir 50 mg \u002F tenofovir alafenamide 25 mg \u002F emtricitabine 200 mg or dolutegravir 50 mg \u002F lamivudine 300 mg \u002F abacavir 600 mg, both combinations in a single tablet.",[9],[27],"INSTI",{"type":22,"name":15,"description":29,"armGroupLabels":30,"otherNames":31},"Intervention arm will be dual therapy oh DTG 50 mg\u002F 3TC 300 mg, this will be compared to standar therapy of 3 drugs",[15],[32],"DTG\u002F3TC",null,[35],{"facility":36,"status":37,"city":38,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Hospital de Infectología, Centro Médico Nacional La Raza","RECRUITING","Mexico City","02990","Mexico","MX",{"type":43,"coordinates":44},"Point",[45,46],-99.12766,19.42847,{"lat":46,"lon":45},[49,54,55],{"name":50,"role":51,"phone":52,"phoneExt":33,"email":53},"José A Mata Marin, Master","CONTACT","55 5724 5900","jamatamarin@gmail.com",{"name":50,"role":51,"phone":33,"phoneExt":33,"email":33},{"name":56,"role":57,"phone":33,"phoneExt":33,"email":33},"Diego A Arteaga Badillo, postgraduate","SUB_INVESTIGATOR",{"type":59,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"SPONSOR_INVESTIGATOR","José Antonio Mata Marín","Doctor","100603563","phase-4-efficacy-safety-and-tolerability-of-switching-to-a-two-drug-regimen-with-dtg3tc-compared-to-maintaining-a-three-drug-regimen-with-bicftctaf-or-dtg3tcabc-in-virologically-suppressed-people-living-with-hiv-after-24-and-48-weeks-of-follow-up-100603563",false,"NCT07138144","Efficacy, Safety, and ToLerability of Switching to A Two-Drug Regimen With DTG\u002F3TC Compared to Maintaining A Three-Drug REgimen With BIC\u002FFTC\u002FTAF or DTG\u002F3TC\u002FABC in ViroLogically SupprEssed PeopLe Living With HIV After 24 and 48 Weeks of Follow-Up","Efficacy, Safety, and Tolerability of Switching to a Two-Drug Regimen With DTG\u002F3TC Compared to Maintaining a Three-Drug Regimen With BIC\u002FFTC\u002FTAF or DTG\u002F3TC\u002FABC in Virologically Suppressed PeopLe Living With HIV After 24 and 48 Weeks of Follow-Up","TLACAELEL","Inclusion Criteria:\n\n* PLWH aged over 18 years.\n* Virologically suppressed for at least 48 weeks prior to study enrollment.\n* On ART with Bictegravir\u002FEmtricitabine\u002FTenofovir Alafenamide (BIC\u002FFTC\u002FTAF) or Dolutegravir\u002FLamivudine\u002FAbacavir (DTG\u002F3TC\u002FABC).\n* No history of virologic failure.\n* Willing to participate in the study.\n* Signed written informed consent.\n* HIV-1 RNA \\\u003C50 copies\u002FmL within 4 weeks prior to randomization.\n* eGFR by CKD-EPI ≥60 mL\u002Fmin.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding patients.\n* Known allergies to any component of the antiretroviral regimens.\n* Coinfection with hepatitis B and\u002For hepatitis C virus.\n* Concomitant medications that interact with any component of the ART regimens.\n* Diagnosis of malignancy prior to randomization.\n* Use of recreational drugs with anorexigenic potential (crystal meth, methamphetamines, cocaine) within 60 days prior to randomization.","ALL","18 Years","70 Years",{"count":74,"type":75},156,"ESTIMATED","INTERVENTIONAL",[78],"PHASE4","This is a phase 4, randomized, controlled, open-label, single-center clinical trial conducted at the Hospital de Infectología, National Medical Center \"La Raza.\" The study employs a non-inferiority design with follow-up assessments at 24 and 48 weeks. The study will enroll 156 PLWH aged ≥18 years who are on ART with BIC\u002FFTC\u002FTAF or DTG\u002F3TC\u002FABC and have maintained virological suppression (HIV-1 RNA \\\u003C50 copies\u002FmL) for at least 48 weeks. Participants will be randomized in a 2:1 ratio: 104 to switch to DTG\u002F3TC and 52 to continue their current regimen (control group).",[81],"HIV Infections",[83,32,84,15,85],"HIV","BIC\u002FTAF\u002FFTC","non-inferiority","2025-08-17",{"date":88,"type":89},"2025-08-22","ACTUAL",{"date":91,"type":89},"2025-07-12",{"date":93,"type":75},"2026-07-30",{"name":60,"class":6},1]