[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603563":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":47,"studyPopulation":39,"armGroups":48,"interventions":61,"overallOfficials":39,"centralContacts":39,"locations":74,"responsibleParty":98,"collaborators":39,"id":102,"slug":39,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":103,"sex":109,"minAge":110,"maxAge":111,"enrollmentInfo":112,"targetDuration":39,"studyType":115,"phases":116,"briefSummary":43,"conditions":118,"keywords":120,"overallStatus":77,"whyStopped":39,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"Instituto Mexicano del Seguro Social","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":39},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Effectiveness.","Effectiveness: Individuals with \\>50 copies\u002Fml.","24 and 48 weeks.",{"measure":14,"description":15,"timeFrame":12},"Safety of switching ART regimen with an INSTI to DTG\u002F3TC.","Number of participants with treatment-related adverse events as assessed of serious adverse events (WHO grade 3 or 4) for PWH treated with DTG\u002F3TC at 24 and 48 weeks, expressed in proportions of new cases.",{"measure":17,"description":18,"timeFrame":12},"Tolerability of switching ART regimen with an INSTI to DTG\u002F3TC.","Maintaining ART with DTG\u002F3TC without changes, interruptions, or substitutions due to adverse effects or perceived discomfort.",[20,24,27,30,33,36],{"measure":21,"description":22,"timeFrame":23},"Changes in lipid profile.","Changes in total cholesterol, HDL cholesterol, and triglycerides, measured in mg\u002FdL.","24 and 48 weeks",{"measure":25,"description":26,"timeFrame":12},"Changes in body mass index","To evaluate changes in body mass index (BMI, kg\u002Fm²) at weeks 24 and 48.",{"measure":28,"description":29,"timeFrame":12},"Changes in waist circumference.","To evaluate changes greater than 90 cm in waist circumference at weeks 24 and 48.",{"measure":31,"description":32,"timeFrame":12},"Glucose metabolism disorders.","To determine changes at weeks 24 and 48, including the development of prediabetes or diabetes.",{"measure":34,"description":35,"timeFrame":23},"Assess changes in blood pressure and cardiovascular risk","Framingham and AHA\u002FACC scales",{"measure":37,"description":38,"timeFrame":23},"Measure body composition","fat, water, muscle",null,{"allocation":41,"interventionModel":42,"interventionModelDescription":43,"primaryPurpose":44,"observationalModel":39,"timePerspective":39,"maskingInfo":45},"RANDOMIZED","PARALLEL","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).","TREATMENT",{"masking":46,"maskingDescription":39,"whoMasked":39},"NONE","Since the identification of the human immunodeficiency virus (HIV), developing effective, safe, and well-tolerated antiretroviral therapy (ART) for people living with HIV (PLWH) has been a global health priority. Advances in ART have significantly improved the prognosis for PLWH, achieving life expectancies comparable to the general population. However, three-drug regimens, such as bictegravir\u002Femtricitabine\u002Ftenofovir alafenamide (BIC\u002FFTC\u002FTAF) or dolutegravir\u002Flamivudine\u002Fabacavir (DTG\u002F3TC\u002FABC), are associated with metabolic, renal, and cardiovascular adverse effects, particularly in the Mexican population, which has a high prevalence of metabolic syndrome.\n\nClinical trials, including GEMINI, TANGO, SALSA, RUMBA, PASO DOBLE, and DYAD, have demonstrated that two-drug regimens, such as dolutegravir\u002Flamivudine (DTG\u002F3TC), offer comparable virological efficacy and improved tolerability. Reducing the pharmacological burden may minimize adverse effects while maintaining viral suppression. The impact of metabolic disturbances on fat weight gain remains a controversial issue.\n\nObjectives General Objective To compare the effectiveness, safety, and tolerability of switching to a DTG\u002F3TC regimen versus continuing BIC\u002FFTC\u002FTAF or DTG\u002F3TC\u002FABC in virally suppressed PLWH at 24 and 48 weeks of treatment.\n\nSecondary Objectives\n\n* Assess changes in lipid profile, body mass index (BMI), and abdominal circumference.\n* Evaluate alterations in glucose metabolism.\n* Measure changes in blood pressure and cardiovascular risk using Framingham and AHA\u002FACC scales.\n* Analyze changes in body composition (fat, water, muscle).\n* Document adverse events associated with ART. Study Design 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).\n\nInclusion Criteria\n\n* Age ≥18 years.\n* Virological suppression (HIV-1 RNA \\\u003C50 copies\u002FmL) for ≥48 weeks.\n* Estimated glomerular filtration rate (eGFR) ≥60 mL\u002Fmin.\n* Signed informed consent. Exclusion Criteria\n* Pregnancy or breastfeeding.\n* Hepatitis B or C coinfection.\n* Active malignancy.\n* Use of recreational drugs or medications with significant interactions with ART.\n\nProcedures Following approval by the local ethics committee, participant recruitment will commence. Participants will be followed continuously for 48 weeks. Data will be collected on efficacy (viral suppression), safety (adverse events), and tolerability (patient-reported outcomes and clinical assessments).\n\nData Management and Statistical Analysis\n\nPatient data will remain confidential and accessible only to study investigators. Data will be recorded in an SPSS database. Statistical analyses will include:\n\n* Kolmogorov-Smirnov test for normality.\n* χ² test for categorical variables.\n* Student's t-test or Mann-Whitney U test for continuous variables, as appropriate.\n* ANOVA for group comparisons.\n* Paired tests for within-group changes. A significance level of p ≤ 0.05 will be applied.\n\nFeasibility The Hospital de Infectología, National Medical Center \"La Raza,\" has the necessary infrastructure, trained personnel, and access to study medications to conduct this trial. The study is independent and not sponsored by any pharmaceutical company.",[49,55],{"label":50,"type":51,"description":52,"interventionNames":53},"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",[54],"Drug: Standard Medical Therapy",{"label":56,"type":57,"description":58,"interventionNames":59},"dual therapy","EXPERIMENTAL","This arm is the experimental one, with dual therapy, 2 drugs: Dolutegravir 50 mg\u002FLamivudina 300 mg, in a single tablet.",[60],"Drug: dual therapy",[62,69],{"type":63,"name":64,"description":65,"armGroupLabels":66,"otherNames":67},"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.",[50],[68],"INSTI",{"type":63,"name":56,"description":70,"armGroupLabels":71,"otherNames":72},"Intervention arm will be dual therapy oh DTG 50 mg\u002F 3TC 300 mg, this will be compared to standar therapy of 3 drugs",[56],[73],"DTG\u002F3TC",[75],{"facility":76,"status":77,"city":78,"state":78,"zip":79,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":87,"contacts":88},"Hospital de Infectología, Centro Médico Nacional La Raza","RECRUITING","Mexico City","02990","Mexico","MX",{"type":83,"coordinates":84},"Point",[85,86],-99.12766,19.42847,{"lat":86,"lon":85},[89,94,95],{"name":90,"role":91,"phone":92,"phoneExt":39,"email":93},"José A Mata Marin, Master","CONTACT","55 5724 5900","jamatamarin@gmail.com",{"name":90,"role":91,"phone":39,"phoneExt":39,"email":39},{"name":96,"role":97,"phone":39,"phoneExt":39,"email":39},"Diego A Arteaga Badillo, postgraduate","SUB_INVESTIGATOR",{"type":99,"investigatorFullName":100,"investigatorTitle":101,"investigatorAffiliation":5,"oldNameTitle":39,"oldOrganization":39},"SPONSOR_INVESTIGATOR","José Antonio Mata Marín","Doctor","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":113,"type":114},156,"ESTIMATED","INTERVENTIONAL",[117],"PHASE4",[119],"HIV Infections",[121,73,122,56,123],"HIV","BIC\u002FTAF\u002FFTC","non-inferiority","2025-08-17",{"date":126,"type":127},"2025-08-22","ACTUAL",{"date":129,"type":127},"2025-07-12",{"date":131,"type":114},"2026-07-30",{"name":100,"class":6},1]