[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"José Antonio Mata Marín\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":104},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,50,78],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100598719","phase-3-dortdf3tc-compared-with-bicftctaf-in-art-nave-people-living-with-hiv-and-overweight-or-obesity-100598719",false,"NCT07075146","DOR\u002FTDF\u002F3TC COmpared With BIC\u002FFTC\u002FTAF in ART-Naïve People Living With HIV and Overweight or Obesity","Doravirine\u002FLamivudine\u002FTenofovir Disoproxil Fumarate COmpared With Bictegravir\u002FEmtricitabine\u002FTenofovir Alafenamide in ART-Naïve People Living With HIV and Overweight or Obesity","COATL","Inclusion Criteria:\n\n1. Adults (≥18 years) with confirmed HIV diagnosis, ART-naïve\n2. Signed informed consent\n3. HIV-1 RNA ≥1000 copies\u002FmL\n4. No history of PrEP or PEP failure\n5. BMI ≥25 kg\u002Fm² and body fat \\>20%\n6. Stable treatment for dyslipidemia (if applicable)\n7. No planned medication changes affecting weight\n8. Willingness to adhere to assigned ART\n9. Recent HIV-1 RNA and CD4+ results\n10. GFR (CKD-EPItip) ≥60 mL\u002Fmin\n11. ALT and AST \\\u003C90 IU\u002FL\n12. Willingness to report dietary or physical activity changes during follow-up Non-Inclusion Criteria\n\n1\\. Uncontrolled diabetes 2. Recent changes in insulin or hypoglycemic drugs (\\\u003C3 months) 3. Active malignancy 4. History of bariatric surgery 5. Allergies to study drugs 6. Hepatitis B and\u002For C coinfection 7. GFR \\\u003C60 mL\u002Fmin (CKD-EPI) 8. Drug interactions with ART regimens 9. Recent (60 days) use of anorectic drugs 10. Recent (30 days) hospitalization for severe illness 11. Unstable hypothyroidism\n\nExclusion Criteria:\n\n1. Loss of social security coverage\n2. Newly discovered allergy to study drugs\n3. Withdrawal of consent\n4. Hepatitis B or C infection acquired during follow-up\n5. Use of psychiatric or thyroid medications without a stable dose for ≥12 weeks\n6. Initiation or discontinuation of medications affecting weight after enrollment\n7. Unplanned bariatric surgery","ALL","18 Years","70 Years",{"count":21,"type":22},306,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","Background:Historically, HIV infection was associated with significant weight loss. However, weight gain is now commonly observed after initiating antiretroviral therapy (ART), particularly in individuals underweight at baseline. It remains unclear whether this weight gain reflects a \"return to health\" or results from drug-related or metabolic effects, and whether it persists beyond immune restoration. Recent evidence indicates that ART regimens containing second-generation integrase strand transfer inhibitors (INSTIs), such as bictegravir combined with tenofovir alafenamide, are associated with greater weight gain compared to other antiretroviral combinations, raising concerns about potential long-term metabolic consequences.Objective:To evaluate the effectiveness, safety, and tolerability of Doravirine\u002FLamivudine\u002FTenofovir Disoproxil Fumarate (DOR\u002F3TC\u002FTDF) compared with Bictegravir\u002FEmtricitabine\u002FTenofovir Alafenamide (BIC\u002FFTC\u002FTAF) in ART-naïve people living with HIV (PWH) who are overweight or obese.Materials and Methods:This open-label, randomized clinical trial, approved by the Ethics and Scientific Research Committee (No. 3502), will be conducted at the Infectious Diseases Hospital of the National Medical Center \"La Raza\" from May 2025 to May 2027. ART-naïve PWH, recently diagnosed, with no prior use of pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP), who do not require hospitalization, and have a body mass index (BMI) ≥25 kg\u002Fm² and body fat \\>20%, will be invited to participate. Participants will provide written informed consent and be randomized 1:1 to receive either DOR\u002F3TC\u002FTDF or BIC\u002FFTC\u002FTAF.",[28,29,30],"HIV - Human Immunodeficiency Virus","Obesity","Overweight and\u002For Obesity",[32,33,34,35,36],"HIV","overweight","obesity","Doravirine","Bictegravir","RECRUITING","2025-08-19",{"date":40,"type":41},"2025-08-24","ACTUAL",{"date":43,"type":41},"2025-05-05",{"date":45,"type":22},"2028-08-01",{"name":47,"class":48},"José Antonio Mata Marín","OTHER_GOV",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":49},"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","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.",{"count":59,"type":22},156,[61],"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).",[64],"HIV Infections",[32,66,67,68,69],"DTG\u002F3TC","BIC\u002FTAF\u002FFTC","dual therapy","non-inferiority","2025-08-17",{"date":72,"type":41},"2025-08-22",{"date":74,"type":41},"2025-07-12",{"date":76,"type":22},"2026-07-30",{"name":47,"class":48},{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":86,"minAge":18,"maxAge":19,"enrollmentInfo":87,"targetDuration":4,"studyType":23,"phases":89,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":49},"100585798","phase-4-effectiveness-and-safety-of-darunavircobicistat-plus-lamivudine-versus-darunavircobicistat-plus-tenofoviremtricitabine-in-virologically-suppressed-hiv-1-positive-individuals-in-mexico-100585798","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",{"count":88,"type":22},138,[61],"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.",[92],"HIV Infection",[32,68,94,95,69],"DRV\u002Fc+3TC","effectiveness","2025-04-01",{"date":98,"type":41},"2025-04-04",{"date":100,"type":41},"2023-11-09",{"date":102,"type":22},"2026-11-30",{"name":47,"class":48},""]