[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576644":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":28,"studyPopulation":20,"armGroups":29,"interventions":42,"overallOfficials":20,"centralContacts":51,"locations":20,"responsibleParty":57,"collaborators":20,"id":61,"slug":20,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":20,"enrollmentInfo":70,"targetDuration":20,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":81,"overallStatus":87,"whyStopped":20,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":20},{"fullName":5,"class":6},"Instituto Mexicano del Seguro Social","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"Change in neuropsychiatric scales for Insomnia","Change in scales evaluating the severity of neuropsychiatric effects (Insomnia Severity Index (ISI) in patients living with HIV who are naïve to antiretroviral therapy who initiate therapy with Dolutegravir + Tenofovir Disoproxil Fumarate\u002FEmtricitabine compared to Darunavir\u002Fcobicistat + Tenofovir Disoproxil Fumarate\u002FEmtricitabine at 12 weeks of treatment.","12 weeks",[14,17],{"measure":15,"description":16,"timeFrame":12},"Discontinuation of ART due to Neuropsychiatric adverde effects","Number of patient discontinuation of ART in patients living with HIV who are naïve to antiretroviral therapy who start therapy with Dolutegravir + Tenofovir Disoproxil Fumarate\u002FEmtricitabine compared to Darunavir\u002Fcobicistat + Tenofovir Disoproxil Fumarate\u002FEmtricitabine after 12 weeks of treatment due to neuropsychiatric.",{"measure":18,"description":19,"timeFrame":12},"Risk factor associated with increase in neuropsychiatric scales","Identify the risk factors associated with the change in neuropsychiatric scales in patients living with HIV who are naïve to antiretroviral therapy and who initiate therapy with Dolutegravir + Tenofovir Disoproxil Fumarate\u002FEmtricitabine compared to Darunavir\u002Fcobicistat + Tenofovir Disoproxil Fumarate\u002FEmtricitabine at 12 weeks of treatment.",null,{"allocation":22,"interventionModel":23,"interventionModelDescription":24,"primaryPurpose":25,"observationalModel":20,"timePerspective":20,"maskingInfo":26},"RANDOMIZED","PARALLEL","Open-label, randomized, clinical trial","SCREENING",{"masking":27,"maskingDescription":20,"whoMasked":20},"NONE","This clinical trial aims to evaluate changes in neuropsychiatric scale (NPS) scores among Mexican men living with HIV who present baseline NPS symptoms and are naïve to antiretroviral therapy (ART). Participants will initiate either a Dolutegravir (DTG)-based regimen or a Darunavir\u002FCobicistat (DRV\u002Fc)-based regimen, both combined with tenofovir disoproxil fumarate\u002Femtricitabine (TDF\u002FFTC). All patients will undergo a psychiatric evaluation prior to ART initiation. Treatment discontinuation will be considered for participants experiencing an exacerbation of NPS symptoms associated with grade ≥2 adverse events. NPS scores will be assessed and compared at weeks 4 and 12.",[30,36],{"label":31,"type":32,"description":33,"interventionNames":34},"DTG + TDF\u002FFTC","EXPERIMENTAL","Dolutegravir + Tenofovir Disoproxil Fumarate \u002F Emtricitabine",[35],"Drug: Dolutegravir (DTG)",{"label":37,"type":38,"description":39,"interventionNames":40},"DRV\u002Fc + TDF\u002FFTC","ACTIVE_COMPARATOR","Darunavir\u002FCobicistat + Tenofovir Disoproxil Fumarate \u002F Emtricitabine",[41],"Drug: Darunavir\u002FCobicistat (FDC)",[43,47],{"type":44,"name":45,"description":33,"armGroupLabels":46,"otherNames":20},"DRUG","Dolutegravir (DTG)",[31],{"type":44,"name":48,"description":49,"armGroupLabels":50,"otherNames":20},"Darunavir\u002FCobicistat (FDC)","Darunavir Cobicistat + TDF\u002FFTC",[37],[52],{"name":53,"role":54,"phone":55,"phoneExt":20,"email":56},"Jose Antonio Mata Marin, Medical Doctor","CONTACT","52 644 1 560193","jamatamarin@gmail.com",{"type":58,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","José Antonio Mata Marín","Principal Investigator","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":71,"type":72},140,"ESTIMATED","INTERVENTIONAL",[75],"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).",[78,79,80],"HIV","Insomnia","Anxiety",[82,78,83,84,85,86,80],"INSTI","Dolutegravir","Darunavir","Suicide","Depression","NOT_YET_RECRUITING","2025-06-21",{"date":90,"type":91},"2025-06-26","ACTUAL",{"date":93,"type":72},"2025-06-19",{"date":95,"type":72},"2026-01-25",{"name":5,"class":6}]