[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585421":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":29,"locations":34,"responsibleParty":147,"collaborators":151,"id":155,"slug":156,"hasResults":157,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":161,"eligibilityCriteria":162,"healthyVolunteers":157,"sex":163,"minAge":164,"maxAge":10,"enrollmentInfo":165,"targetDuration":168,"studyType":169,"phases":10,"briefSummary":170,"conditions":171,"keywords":173,"overallStatus":37,"whyStopped":10,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":187},{"fullName":5,"class":6},"Association pour la promotion de la recherche en maladies infectieuses et tropicales dans le Loiret","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Adults living with HIV-1 receiving or starting once-daily B\u002FF\u002FTAF-based antiretroviral therapy",null,"Given our interest in covering a wide range of adherence profiles of B\u002FF\u002FTAF, the participation of PLHIV perceived by their physicians to be at risk of suboptimal adherence, such as a history of pre-existing resistance that does not affect B\u002FF\u002FTAF, immigrants\u002Fmigrants, homeless\u002Fpoorly housed, those with substance use disorders, transgender women, youth and those facing mental health issues, will be encouraged",[13],"Device: Adherence measured by MEMS caps",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","Adherence measured by MEMS caps","The methodological choices made in this study are justified by the need to assess the effectiveness of bictegravir, taking into account the varying levels of adherence among PLHIV. The use of electronic antiretroviral caps (MEMS caps: https:\u002F\u002Faardexgroup.com\u002Fmedication-event-monitoring-system\u002F ) and the intra-cellular TAF assay to measure drug concentrations will enable a combined, precise and objective assessment of treatment adherence, and constitute the originality of this research.",[9],[21,25],{"name":22,"affiliation":23,"role":24},"Laurent HOCQUELOUX, M.D.","CHU d'Orléans (France)","PRINCIPAL_INVESTIGATOR",{"name":26,"affiliation":27,"role":28},"Jean-Jacques PARIENTI, M.D., PhD","CHU de Caen (France)","STUDY_DIRECTOR",[30],{"name":22,"role":31,"phone":32,"phoneExt":10,"email":33},"CONTACT","+33 2 38 22 95 88","laurent.hocqueloux@chu-orleans.fr",[35,52,66,79,92,105,121,134],{"facility":36,"status":37,"city":38,"state":10,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"CHU de Caen","RECRUITING","Caen","14000","France","FR",{"type":43,"coordinates":44},"Point",[45,46],-0.35912,49.18585,{"lat":46,"lon":45},[49],{"name":26,"role":31,"phone":50,"phoneExt":10,"email":51},"+33 2 31 06 57 74","parienti-jj@chu-caen.fr",{"facility":53,"status":54,"city":55,"state":10,"zip":56,"country":40,"countryCode":41,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"CHD Vendée","NOT_YET_RECRUITING","La Roche-sur-Yon","85000",{"type":43,"coordinates":58},[59,60],-1.42757,46.66974,{"lat":60,"lon":59},[63],{"name":64,"role":31,"phone":10,"phoneExt":10,"email":65},"Dominique MERRIEN, M.D.","dominique.merrien@ght85.fr",{"facility":67,"status":54,"city":68,"state":10,"zip":69,"country":40,"countryCode":41,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Hôpitaux Civils de Lyon","Lyon","69000",{"type":43,"coordinates":71},[72,73],4.84789,45.74906,{"lat":73,"lon":72},[76],{"name":77,"role":31,"phone":10,"phoneExt":10,"email":78},"Agathe BECKER, M.D.","agathe.becker01@chu-lyon.fr",{"facility":80,"status":54,"city":81,"state":10,"zip":82,"country":40,"countryCode":41,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"CHU de Nantes","Nantes","44000",{"type":43,"coordinates":84},[85,86],-1.55336,47.21725,{"lat":86,"lon":85},[89],{"name":90,"role":31,"phone":10,"phoneExt":10,"email":91},"Clotilde ALLAVENA, M.D.","clotilde.allavena@chu-nantes.fr",{"facility":93,"status":54,"city":94,"state":10,"zip":95,"country":40,"countryCode":41,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"CH de Niort","Niort","79000",{"type":43,"coordinates":97},[98,99],-0.45877,46.32313,{"lat":99,"lon":98},[102],{"name":103,"role":31,"phone":10,"phoneExt":10,"email":104},"Simon SUNDER, M.D.","simon.sunder@ch-niort.fr",{"facility":106,"status":37,"city":107,"state":10,"zip":108,"country":40,"countryCode":41,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"CHU d'Orléans","Orléans","45100",{"type":43,"coordinates":110},[111,112],1.90407,47.90248,{"lat":112,"lon":111},[115,117,118],{"name":116,"role":31,"phone":32,"phoneExt":10,"email":33},"Laurent HOCQUELOUX",{"name":22,"role":24,"phone":10,"phoneExt":10,"email":10},{"name":119,"role":120,"phone":10,"phoneExt":10,"email":10},"Thierry PRAZUCK, M.D., PhD","SUB_INVESTIGATOR",{"facility":122,"status":54,"city":123,"state":10,"zip":124,"country":40,"countryCode":41,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"CHU Pitié-Salpétrière","Paris","75013",{"type":43,"coordinates":126},[127,128],2.3488,48.85341,{"lat":128,"lon":127},[131],{"name":132,"role":31,"phone":10,"phoneExt":10,"email":133},"Romain PALICH, M.D.","romain.palich@aphp.fr",{"facility":135,"status":54,"city":136,"state":10,"zip":137,"country":40,"countryCode":41,"cosmosGeoPoint":138,"geoPoint":142,"contacts":143},"CHU de Poitiers","Poitiers","86000",{"type":43,"coordinates":139},[140,141],0.34348,46.58261,{"lat":141,"lon":140},[144],{"name":145,"role":31,"phone":10,"phoneExt":10,"email":146},"Gwénaël LE MOAL, M.D.","gwenael.le-moal@chu-poitiers.fr",{"type":24,"investigatorFullName":148,"investigatorTitle":149,"investigatorAffiliation":150,"oldNameTitle":10,"oldOrganization":10},"Laurent HOCQUELOUX, MD","Investigator coordinator","Centre Hospitalier Régional d'Orléans",[152],{"name":153,"class":154},"Hôpital Côte de Nacre, CHU de Caen","UNKNOWN","100585421","prospective-multicenter-study-of-the-relationship-between-virological-effectiveness-and-compliance-in-hiv-1-infected-patients-treated-with-bictegravir-100585421",false,"NCT06902142","Prospective Multicenter Study of the Relationship Between Virological Effectiveness and Compliance in HIV-1-infected Patients Treated With Bictegravir","Étude Multicentrique Prospective de la Relation Entre Efficacité Virologique et Observance Chez Des Patients Infectés Par le VIH-1 Traités Par Bictegravir","BICTECAPS","Inclusion Criteria:\n\n* People living with HIV-1\n* Age greater than or equal to 18 years\n* Having been informed about the study (non-opposition)\n* Acceptance of the use of electronic antiretroviral monitoring caps (MEMS caps)\n* People treated or starting treatment with bictegravir\u002F\u002Femtricitabine\u002Ftenofovir (B\u002FF\u002FTAF; antiretroviral treatment naïve, changing treatment, virological failure)\n\nExclusion Criteria:\n\n* Pregnant women\n* People living with HIV (PLHIV) living in institutionalization, with guardianship or impaired judgment (to avoid bias due to unability to assume responsibility for treatment compliance)\n* PLHIV receiving assistance incompatible with the use of the electronic pillbox.","ALL","18 Years",{"count":166,"type":167},120,"ESTIMATED","12 Months","OBSERVATIONAL","Modern once-daily antiretroviral therapies have evolved considerably, improving patients' quality of life. However, sub-optimal adherence to antiretroviral therapy (ART) can lead to insufficient viral suppression and the emergence of resistant HIV strains. In particular, several populations encountered in HIV clinical practice face obstacles to optimal adherence.\n\nThe investigators propose the prospective multicenter cohort study BICTECAPS, evaluating the effectiveness of the combination therapy bictegravir\u002Femtricitabine\u002Ftenofovir alafenamide (B\u002FF\u002FTAF) in routine practice. The investigators hypothesize that the pharmacokinetic profile and genetic barrier provided by B\u002FF\u002FTAF will enable a high rate of virological suppression at low to moderate levels of adherence, probably 100% virological suppression above 70% adherence.\n\nThe study is planned to include 120 patients with HIV infection treated with B\u002FF\u002FTAF, over a planned 2-year period with usual follow-up.\n\nThe aim of this work is to evaluate virological suppression rates at 6 and 12 months according to adherence levels defined by electronic antiretroviral monitoring caps (MEMS caps) and by intra-cellular TAF assay on blotting paper (dried blood spot, DBS).\n\nThe investigators hope to generate real-life data on B\u002FF\u002FTAF use from population groups generally under-represented in clinical trials, including robust measurements of adherence patterns using MEMS caps and DBS.\n\n. Key words : HIV-1 ; B\u002FF\u002FTAF ; Adherence ; Forgiveness",[172],"HIV Antiretroviral Therapy (ART) Adherence",[174,175,176,177],"HIV-1","B\u002FF\u002FTAF","Adherence","Forgiveness","2025-03-31",{"date":180,"type":181},"2025-04-03","ACTUAL",{"date":183,"type":181},"2025-02-11",{"date":185,"type":167},"2027-09-01",{"name":5,"class":6},8]