[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576644":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":30,"locations":25,"responsibleParty":36,"collaborators":25,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":42,"sex":48,"minAge":49,"maxAge":25,"enrollmentInfo":50,"targetDuration":25,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":61,"overallStatus":67,"whyStopped":25,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":25},{"fullName":5,"class":6},"Instituto Mexicano del Seguro Social","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"DTG + TDF\u002FFTC","EXPERIMENTAL","Dolutegravir + Tenofovir Disoproxil Fumarate \u002F Emtricitabine",[13],"Drug: Dolutegravir (DTG)",{"label":15,"type":16,"description":17,"interventionNames":18},"DRV\u002Fc + TDF\u002FFTC","ACTIVE_COMPARATOR","Darunavir\u002FCobicistat + Tenofovir Disoproxil Fumarate \u002F Emtricitabine",[19],"Drug: Darunavir\u002FCobicistat (FDC)",[21,26],{"type":22,"name":23,"description":11,"armGroupLabels":24,"otherNames":25},"DRUG","Dolutegravir (DTG)",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Darunavir\u002FCobicistat (FDC)","Darunavir Cobicistat + TDF\u002FFTC",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Jose Antonio Mata Marin, Medical Doctor","CONTACT","52 644 1 560193","jamatamarin@gmail.com",{"type":37,"investigatorFullName":38,"investigatorTitle":39,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","José Antonio Mata Marín","Principal Investigator","100576644","phase-4-effect-of-dolutegravir-compared-with-darunavircobicistat-on-the-severity-of-neuropsychiatric-effects-al-12-weeks-in-antirretroviral-treatment-naive-adults-100576644",false,"NCT06787976","Effect of Dolutegravir Compared With Darunavir\u002FCobicistat on the Severity of Neuropsychiatric Effects al 12 Weeks in Antirretroviral Treatment-Naive Adults.","Effect of Dolutegravir + Tenofovir Disoproxil Fumarato\u002FEmtricitabina Compared With Darunavir\u002FCobicistat + Tenofovir Disoproxil\u002FFumarato \u002FEmtricitabina on the Severity of Neuropsychiatric Effects al 12 Weeks in Antirretroviral Treatment-Naive Adults With HIV-1 Infection","MORFEO","Inclusion Criteria:\n\n* Patients living with HIV not experienced to ART\n* Age ≥ 18 years.\n* eGFR \\>60 mL\u002Fmin\n* Beneficiaries of the Mexican Social Security Institute treated at the \"La Raza\" National Medical Center\n* Patients with a baseline ISI scale score: ≥8-14 points\n* Patients with a baseline PHQ-9 scale score: 5-9 points\n* Patients with a baseline HADS-A scale score: 8-10 points\n* Patients with a baseline HADS-D scale score: 8-10 points\n* Patients with a baseline Pittsburgh scale score: 5-7 points.\n\nExclusion Criteria:\n\n* Patients with use of antidepressants\u002Fanxiolytics prior to starting ART\n* Any Contraindication for the use of second generation INSTI or IP ART regimen\n* Coinfection with Hepatitis C Virus\n* Known resistance mutations to any of the components of both treatment regimens.","ALL","18 Years",{"count":51,"type":52},140,"ESTIMATED","INTERVENTIONAL",[55],"PHASE4","This clinical trial aimed at evaluating changes in neuropsychiatric scales for depression, anxiety, insomnia, and sleep quality in people living with HIV (PLHIV) who initiate antiretroviral therapy (ART) with a regimen of Dolutegravir (DTG) or Darunavir\u002FCobicistat (DRV\u002Fc), both combined with tenofovir disoproxil fumarate\u002Femtricitabine (TDF\u002FFTC).",[58,59,60],"HIV","Insomnia","Anxiety",[62,58,63,64,65,66,60],"INSTI","Dolutegravir","Darunavir","Suicide","Depression","NOT_YET_RECRUITING","2025-06-21",{"date":70,"type":71},"2025-06-26","ACTUAL",{"date":73,"type":52},"2025-06-19",{"date":75,"type":52},"2026-01-25",{"name":5,"class":6}]