[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598719":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":43,"responsibleParty":63,"collaborators":67,"id":69,"slug":25,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":25,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":90,"overallStatus":46,"whyStopped":25,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Instituto Mexicano del Seguro Social","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"BIC\u002FTAF\u002FFTC","ACTIVE_COMPARATOR","Bictegravir\u002F tenofovir alafenamide\u002F emtricitabine 50\u002F 25\u002F 200 mg. It is the usual therapy, consisting of 3 drugs in a single tablet, based on an integrase inhibitor, and 2 nucleoside analogues, it is the experimental group",[13],"Drug: BIC\u002FFTC\u002FTAF",{"label":15,"type":16,"description":17,"interventionNames":18},"DOR\u002F3TC\u002FTDF","EXPERIMENTAL","Doravirine\u002FLamivudine\u002FTenofovir Disoproxil Fumarate 100\u002F300\u002F300 mg Non-nucleoside reverse transcriptase inhibitor (doravirine) Nucleoside reverse transcriptase inhibitors (lamivudine, tenofovir disoproxil fumarate)",[19],"Drug: DOR\u002F3TC\u002FTDF",[21,26],{"type":22,"name":15,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","It is a triple-drug antiretroviral drug co-formulated in a single tablet. It contains Doravirine\u002FLamivudine\u002FTenofovir Disoproxil Fumarate 100\u002F300\u002F300 mg",[15],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"BIC\u002FFTC\u002FTAF","It is a triple-drug antiretroviral drug co-formulated in a single tablet. It contains bictegravir 50 mg, tenofovir alafenamide 25 mg, and emtricitabine 200 mg. It is the standard therapy.",[9],[31],{"name":32,"affiliation":5,"role":33},"José A Mata, M.Sc","PRINCIPAL_INVESTIGATOR",[35,39],{"name":32,"role":36,"phone":37,"phoneExt":25,"email":38},"CONTACT","525530379053","jamatamarin@gmail.com",{"name":40,"role":36,"phone":41,"phoneExt":25,"email":42},"Paola E Padilla, Student","5527946030","paolaedith1b@gmail.com",[44],{"facility":45,"status":46,"city":47,"state":25,"zip":48,"country":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Hospital de infectología, Centro Médico Nacional La Raza","RECRUITING","Mexico City","02990","Mexico",{"type":51,"coordinates":52},"Point",[53,54],-99.12766,19.42847,{"lat":54,"lon":53},[57,59,62],{"name":58,"role":36,"phone":37,"phoneExt":25,"email":38},"José A Mata, Master degree",{"name":60,"role":36,"phone":25,"phoneExt":25,"email":61},"Ana C Díaz, postgraduate","ana.knodiaz@gmail.com",{"name":32,"role":33,"phone":25,"phoneExt":25,"email":25},{"type":64,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","José Antonio Mata Marín","Principal investigator",[68],{"name":5,"class":6},"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":80,"type":81},306,"ESTIMATED","INTERVENTIONAL",[84],"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.",[87,88,89],"HIV - Human Immunodeficiency Virus","Obesity","Overweight and\u002For Obesity",[91,92,93,94,95],"HIV","overweight","obesity","Doravirine","Bictegravir","2025-08-19",{"date":98,"type":99},"2025-08-24","ACTUAL",{"date":101,"type":99},"2025-05-05",{"date":103,"type":81},"2028-08-01",{"name":65,"class":6},1]