[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100338365":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":31,"responsibleParty":72,"collaborators":74,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":80,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":26,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":26,"overallStatus":98,"whyStopped":26,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Fundacion SEIMC-GESIDA","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1","ACTIVE_COMPARATOR","Patients who postpone switching from ABC\u002F3TC\u002FDTG to Symtuza® (TAF\u002FFTC\u002FDRV\u002Fc) four weeks",[13],"Drug: ABC\u002F3TC\u002FDTG + Symtuza® (TAF\u002FFTC\u002FDRV\u002Fc)",{"label":15,"type":16,"description":17,"interventionNames":18},"Arm 2","EXPERIMENTAL","Patients who switch from ABC\u002F3TC\u002FDTG to Symtuza® (TAF\u002FFTC\u002FDRV\u002Fc) during the baseline visit",[19],"Drug: Symtuza® (TAF\u002FFTC\u002FDRV\u002Fc)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Symtuza® (TAF\u002FFTC\u002FDRV\u002Fc)","Treatment with TAF\u002FFTC\u002FDRV\u002Fc during 8 weeks since randomized",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"ABC\u002F3TC\u002FDTG + Symtuza® (TAF\u002FFTC\u002FDRV\u002Fc)","Patients continuing on treatment with DTG\u002F3TC\u002FABC after the randomization for 4 weeks, and then switch to TAF\u002FFTC\u002FDRV\u002Fc for 8 weeks",[9],[32,44,52,57,62,67],{"facility":33,"status":26,"city":34,"state":35,"zip":26,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":26},"Hospital Puerta de Hierro","Majadahonda","Madrid","Spain","ES",{"type":39,"coordinates":40},"Point",[41,42],-3.87182,40.47353,{"lat":42,"lon":41},{"facility":45,"status":26,"city":35,"state":26,"zip":46,"country":36,"countryCode":37,"cosmosGeoPoint":47,"geoPoint":51,"contacts":26},"Hospital Univ. 12 de Octubre","28041",{"type":39,"coordinates":48},[49,50],-3.70256,40.4165,{"lat":50,"lon":49},{"facility":53,"status":26,"city":35,"state":26,"zip":26,"country":36,"countryCode":37,"cosmosGeoPoint":54,"geoPoint":56,"contacts":26},"H. Univ. Príncipe de Asturias",{"type":39,"coordinates":55},[49,50],{"lat":50,"lon":49},{"facility":58,"status":26,"city":35,"state":26,"zip":26,"country":36,"countryCode":37,"cosmosGeoPoint":59,"geoPoint":61,"contacts":26},"Hospital Fundación Jimenez Diaz",{"type":39,"coordinates":60},[49,50],{"lat":50,"lon":49},{"facility":63,"status":26,"city":35,"state":26,"zip":26,"country":36,"countryCode":37,"cosmosGeoPoint":64,"geoPoint":66,"contacts":26},"Hospital Infanta Leonor",{"type":39,"coordinates":65},[49,50],{"lat":50,"lon":49},{"facility":68,"status":26,"city":35,"state":26,"zip":26,"country":36,"countryCode":37,"cosmosGeoPoint":69,"geoPoint":71,"contacts":26},"Hospital Universitario La Paz",{"type":39,"coordinates":70},[49,50],{"lat":50,"lon":49},{"type":73,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[75],{"name":76,"class":77},"Janssen-Cilag, S.A.","INDUSTRY","100338365","phase-4-a-clinical-trial-to-evaluate-the-reversibility-of-abacavirlamivudinedolutegravir-cns-related-neurotoxicity-after-switching-to-tenofoviralafenamideemtricitabinedarunavircobicistat-tafftcdrvc-100338365",false,"NCT03685500","A Clinical Trial to Evaluate the Reversibility of Abacavir\u002FLamivudine\u002FDolutegravir CNS-Related Neurotoxicity After Switching to Tenofovir\u002FAlafenamide\u002FEmtricitabine\u002FDarunavir\u002FCobicistat (TAF\u002FFTC\u002FDRV\u002Fc)","Phase IV, Open Label, Randomized, Clinical Trial to Evaluate the Reversibility of Abacavir\u002FLamivudine\u002FDolutegravir CNS-Related Neurotoxicity After Switching to Tenofovir Alafenamide\u002FEmtricitabine\u002FDarunavir\u002FCobicistat","DETOX","Inclusion Criteria:\n\n* Patient ≥ 18 years of age diagnosed with HIV using conventional serology techniques.\n* Current antiretroviral therapy with ABC\u002F3TC\u002FDTG for at least 4 weeks.\n* HIV viral load \\\u003C 50 copies\u002FmL for at least 24 weeks prior to signing the consent form (confirmed by two assays at least 12 weeks apart with viremia \\\u003C 50 copies\u002FmL between both). If the patient has a recent routine blood test available (≤ 4 weeks) that includes determining HIV viral load, these results may be used for the screening visit. If this test is not available, or the test is more than four weeks old, viral load will be determined on the day of screening in order to confirm that the patient meets this criterion.\n* A positive screening test for sleep disorders detected using the sleep quality index (Pittsburgh ).\n\nExclusion Criteria:\n\n* Determination of at least one HIV viral load ≥ 50 copies\u002FmL in the last 12 weeks.\n* Allergy, intolerance or existence of resistance mutations to any of the components of TAF\u002FFTC\u002FDRV\u002Fc.\n* History of active CNS infections.\n* Active psychosis, major depression with psychotic symptoms or autolytic ideation.\n* Dementia or mental retardation.\n* Drug use with a diagnosis of abuse or dependence according to DSM-5 criteria.\n* Illnesses that may interfere with the study procedures.\n* Inability to complete any of the study procedures.\n* Pregnant or nursing women, as well as women of childbearing age who do not agree to use an adequate birth control method.\n* Patient with documented intolerance or hypersensitivity to the study medication, or who has a contraindication to use it, according to the technical data sheet","ALL","18 Years","100 Years",{"count":90,"type":91},78,"ACTUAL","INTERVENTIONAL",[94],"PHASE4","A phase IV, multicentre, randomised, open-label, pilot clinical trial to evaluate the Reversibility of abacavir\u002Flamivudine\u002Fdolutegravir ( ABC\u002F3TC\u002FDTG) CNS-Related Neurotoxicity After Switching to tenofovir alafenamide\u002Femtricitabine\u002Fdarunavir\u002Fcobicistat (TAF\u002FFTC\u002FDRV\u002Fc)",[97],"HIV Infections","COMPLETED","2022-06-20",{"date":101,"type":91},"2022-06-22",{"date":103,"type":91},"2018-12-04",{"date":105,"type":91},"2020-06-25",{"name":5,"class":6},6]