[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585798":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":33,"locations":34,"responsibleParty":62,"collaborators":33,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":33,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":37,"whyStopped":33,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"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","Darunavir\u002Fcobicistat 800\u002F150 mg + tenofovir\u002Femtricitabin 300\u002F200 mg This arm is the commonly used therapy or standard 3-drug therapy consisting of Darunavir\u002Fcobicistad 800\u002F150 mg, plus tenofovir\u002Femtricitabine 300\u002F200 mg",[13],"Drug: Standard Medical Therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Dual therapy","EXPERIMENTAL","Darunavir\u002Fcobicistat 800\u002F150 mg + lamivudine 300 mg This arm is the experimental one, with dual therapy, 2 drugs: darunavir\u002Fcobicistat 800\u002F150 mg plus lamivudine 300 mg",[19],"Drug: dual therapy",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","dual therapy","Intervention arm will be dual therapy oh DRV\u002FC 800\u002F150 mg + 3TC 300 mg, this will be compared to standar therapy of 3 drugs with: DRV\u002Fc 800\u002F150 mg + TDF\u002FFTC 300\u002F200 mg",[15],[27],"DRV\u002Fc+3TC",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Standard Medical Therapy","DRV\u002Fc+TDF\u002FFTC",[9],[30],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},[49,54,57,59],{"name":50,"role":51,"phone":52,"phoneExt":33,"email":53},"Ana Cano, Posgraduated","CONTACT","2291243665","ana.knodiaz@gmail.com",{"name":55,"role":51,"phone":33,"phoneExt":33,"email":56},"José A Mata, Master degree","jamatamarin@gmail.com",{"name":55,"role":58,"phone":33,"phoneExt":33,"email":33},"PRINCIPAL_INVESTIGATOR",{"name":60,"role":61,"phone":33,"phoneExt":33,"email":33},"Ana L Cano, postgraduate","SUB_INVESTIGATOR",{"type":63,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"SPONSOR_INVESTIGATOR","José Antonio Mata Marín","Doctor","100585798","phase-4-effectiveness-and-safety-of-darunavircobicistat-plus-lamivudine-versus-darunavircobicistat-plus-tenofoviremtricitabine-in-virologically-suppressed-hiv-1-positive-individuals-in-mexico-100585798",false,"NCT06907056","Effectiveness and Safety of Darunavir\u002FCobicistat Plus Lamivudine Versus Darunavir\u002FCobicistat Plus Tenofovir\u002FEmtricitabine in Virologically Suppressed HIV-1-positive Individuals in Mexico","Effectiveness, Safety, and Tolerability of Darunavir\u002FCobicistat Plus Lamivudine Versus Darunavir\u002FCobicistat Plus Tenofovir\u002FEmtricitabine in Virologically Suppressed HIV-1-positive Individuals: 48-week Follow-up in Mexico","TLALOC","Inclusion Criteria:\n\n* Men with HIV infection who are virologically suppressed with DRV\u002Fc (800 mg\u002F150 mg) + TFV\u002FFTC (300 mg\u002F200 mg) for at least 6 months\n* Age ≥18 years-70 years\n* eGFR ≥30 mL\u002Fmin\n* Written informed consent\n* Beneficiaries of the Mexican Social Security Institute 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 medical insurance\n* Presence of tuberculosis or other opportunistic infection requiring adjustment of the ARV regimen\n* Incomplete data collected during visits Uncontrolled chronic gastrointestinal conditions Desire to be on a single-dose regimen Coinfection with hepatitis B virus during follow-up if in the DRV\u002F3TC arm Coinfection with hepatitis C virus during follow-up","MALE","18 Years","70 Years",{"count":78,"type":79},138,"ESTIMATED","INTERVENTIONAL",[82],"PHASE4","Unicenter, open-label, randomized, noninferiority trial included men with HIV-1 RNA levels \\\u003C50 copies\u002Fml for at least 6 months on antiretroviral therapy with DRV\u002Fc + TFV\u002FFTC (standar therapy), aged over 18 years. Participants were randomized to either continue standard therapy or switch to DRV\u002Fc+3TC. The primary end point was the proportion of subjects with HIV-1 RNA levels \\>50 copies\u002Fml after 48 weeks of follow-up according to the snapshot algorithm, with a non-inferiority margin of up to 10%. For statistical analysis, data distribution will be identified using the Kolmogorov-Smirnov test; categorical data will be analyzed using the X2 or Fisher test, as appropriate, and will be expressed as numbers and percentages. Quantitative data will be expressed as medians and interquartile ranges or means with standard deviations. A first analysis will be performed at 24 weeks, with follow-up at 48 weeks. The Student's t-test or the Mann-Whitney U-test will be used for data from independent groups according to their distribution.",[85],"HIV Infection",[87,23,27,88,89],"HIV","effectiveness","non-inferiority","2025-04-01",{"date":92,"type":93},"2025-04-04","ACTUAL",{"date":95,"type":93},"2023-11-09",{"date":97,"type":79},"2026-11-30",{"name":64,"class":6},1]