[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585798":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":28,"studyPopulation":20,"armGroups":29,"interventions":42,"overallOfficials":20,"centralContacts":20,"locations":55,"responsibleParty":83,"collaborators":20,"id":87,"slug":20,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":88,"sex":94,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":20,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":106,"overallStatus":58,"whyStopped":20,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Instituto Mexicano del Seguro Social","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"Effectiveness","Individuals with \\>50 copies\u002Fml","48 weeks",[14,17],{"measure":15,"description":16,"timeFrame":12},"Non-inferiority","Delta between standard and experimental therapy \\\u003C10%",{"measure":18,"description":19,"timeFrame":12},"Safety","Adverse events by group and drug tolerability will be reported by device and system, and their severity will be based on the Division of AIDS (DAIDS) Antiretroviral Drug-Associated Adverse Event Severity Scale, which categorizes them in severity from 1 to 4. Grade 1: Mild or no harm; Grade 2: Moderate adverse events or minimal interference with social and functional activities; Grade 3: Severe symptoms causing inability to perform social\u002Ffunctional activities or requiring hospitalization. Grade IV: Those that are life-threatening with symptoms causing inability to perform basic self-care and where intervention is required to prevent permanent deterioration or death.",null,{"allocation":22,"interventionModel":23,"interventionModelDescription":24,"primaryPurpose":25,"observationalModel":20,"timePerspective":20,"maskingInfo":26},"RANDOMIZED","PARALLEL","Unicenter, open-label, randomized, noninferiority trial, 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, 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.","TREATMENT",{"masking":27,"maskingDescription":20,"whoMasked":20},"NONE","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.\n\nSubject to prior approval of the protocol by the local scientific research ethics committee and the relevant agencies, patients being monitored at the HIV clinic at the Infectious Diseases Hospital of the CMN \"La Raza\" who are living with HIV and receiving treatment with DRV\u002Fc + TFV\u002FFTC for virological suppression will be identified as candidates for participation in the study.\n\nThey will be invited to participate in the study protocol, and the project and its likely outcomes will be explained in detail to the subjects. It will be explained that treatment assignment will be randomized using the digital system (MEDSHARING: randomizer for clinical trials) to one of two arms:\n\n1. DRV\u002Fc (800 mg\u002F150 mg once daily) + 3TC (300 mg once daily) or\n2. DRV\u002Fc (800 mg\u002F150 mg once daily) + TFV\u002FFTC (300 mg\u002F200 mg once daily). Answers will be obtained during the medical interview, allowing the patient to freely decide whether to continue or withdraw from the study during the study period without affecting their medical care at the HIV clinic. Informed consent will be obtained, and to maintain privacy, a patient ID number will be assigned at the time of recruitment. Weight (kg), height (cm), body mass index (BMI) (kg\u002Fheight (m2), body composition (fat, water, muscle, kg, bone, kg) will be measured using the FitScan BC-545F segmental body composition monitor, and waist and hip measurements will be measured using a tape measure. Laboratory studies will include a complete blood count, complete blood chemistry with glucose and creatinine, a complete lipid profile, and post-randomization liver function tests at 4 weeks, 12 weeks, 24 weeks, and 48 weeks post-switch. CD4+ and HIV-1 RNA determinations will be performed prior to randomization, and at 3 months, 6 months, and 12 months post-study entry. Comparisons will be made between measurements taken prior to entry, 24 weeks, and 48 weeks post-study entry. Serum electrolytes (phosphorus, magnesium, calcium), cystatin C, and urinary electrolytes (phosphorus, magnesium, calcium, creatinine, urea, microproteins) will be measured prior to randomization and at 24 and 48 weeks post-switch.\n\nIf patients present with elevated AST and\u002For ALT \\>90 IU\u002FL, serology tests will be ordered to rule out HBV and HCV.\n\nThe ISI, PHQ-9, HADS-A, and HADS-D questionnaires will be administered to assess anxiety, depression, and sleep quality. Additionally, the HIVTSQ questionnaire will be administered to assess treatment satisfaction at weeks 4, 12, 24, and 48 weeks post-randomization, and the HIV-SDM questionnaire will be administered to assess HIV-related symptoms and distress. At each medical visit, potential drug-related adverse effects will be deliberately inquired about by device and system, and will be classified into four grades using the DAIDS adverse event scale.",[30,36],{"label":31,"type":32,"description":33,"interventionNames":34},"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",[35],"Drug: Standard Medical Therapy",{"label":37,"type":38,"description":39,"interventionNames":40},"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",[41],"Drug: dual therapy",[43,50],{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"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",[37],[49],"DRV\u002Fc+3TC",{"type":44,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"Standard Medical Therapy","DRV\u002Fc+TDF\u002FFTC",[31],[52],[56],{"facility":57,"status":58,"city":59,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Hospital de Infectología, Centro Médico Nacional La Raza","RECRUITING","Mexico City","02990","Mexico","MX",{"type":64,"coordinates":65},"Point",[66,67],-99.12766,19.42847,{"lat":67,"lon":66},[70,75,78,80],{"name":71,"role":72,"phone":73,"phoneExt":20,"email":74},"Ana Cano, Posgraduated","CONTACT","2291243665","ana.knodiaz@gmail.com",{"name":76,"role":72,"phone":20,"phoneExt":20,"email":77},"José A Mata, Master degree","jamatamarin@gmail.com",{"name":76,"role":79,"phone":20,"phoneExt":20,"email":20},"PRINCIPAL_INVESTIGATOR",{"name":81,"role":82,"phone":20,"phoneExt":20,"email":20},"Ana L Cano, postgraduate","SUB_INVESTIGATOR",{"type":84,"investigatorFullName":85,"investigatorTitle":86,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"SPONSOR_INVESTIGATOR","José Antonio Mata Marín","Doctor","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":98,"type":99},138,"ESTIMATED","INTERVENTIONAL",[102],"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.",[105],"HIV Infection",[107,45,49,108,109],"HIV","effectiveness","non-inferiority","2025-04-01",{"date":112,"type":113},"2025-04-04","ACTUAL",{"date":115,"type":113},"2023-11-09",{"date":117,"type":99},"2026-11-30",{"name":85,"class":6},1]