[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100431020":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":39,"centralContacts":43,"locations":49,"responsibleParty":88,"collaborators":38,"id":90,"slug":91,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":92,"sex":98,"minAge":99,"maxAge":38,"enrollmentInfo":100,"targetDuration":38,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":52,"whyStopped":38,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Chelsea and Westminster NHS Foundation Trust","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Immediate Switch","EXPERIMENTAL","Two-pill regimen, doravirine (100 mg) + dolutegravir (50 mg) tablets taken orally once daily for 96 weeks.",[13,14],"Drug: Doravirine","Drug: Dolutegravir",{"label":16,"type":6,"description":17,"interventionNames":18},"Delayed Switch","Participants will continue their current triple cART regimen for 48 weeks. Patients will then be switched to two-pill regimen, doravirine (100 mg) + dolutegravir (50 mg) tablets taken orally once daily for 48 weeks.",[13,14,19],"Other: Triple cART regimen",[21,28,34],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Doravirine","Antiretroviral, Non-nucleoside Reverse Transcriptase Inhibitor",[16,9],[27],"Pifeltro",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Dolutegravir","Antiretroviral, Integrase strand transfer inhibitors",[16,9],[33],"Tivicay",{"type":6,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"Triple cART regimen","Participant standard triple cART regimen",[16],null,[40],{"name":41,"affiliation":5,"role":42},"Marta Boffito, MD PhD FRCP","PRINCIPAL_INVESTIGATOR",[44],{"name":45,"role":46,"phone":47,"phoneExt":38,"email":48},"Research Regulatory Compliance Manager","CONTACT","020 3315 6825","chelwest.research@nhs.net",[50,67,79],{"facility":51,"status":52,"city":53,"state":38,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Mortimer Market Centre","RECRUITING","London","NW1 0PE","United Kingdom","UK",{"type":58,"coordinates":59},"Point",[60,61],-0.12574,51.50853,{"lat":61,"lon":60},[64],{"name":65,"role":46,"phone":38,"phoneExt":38,"email":66},"Rubina Choudhry","contact.noclor@nhs.net",{"facility":68,"status":52,"city":53,"state":38,"zip":69,"country":55,"countryCode":56,"cosmosGeoPoint":70,"geoPoint":72,"contacts":73},"Chelsea & Westminster Hospital NHS Foundation Trust","SW10 9NH",{"type":58,"coordinates":71},[60,61],{"lat":61,"lon":60},[74,76,77],{"name":45,"role":46,"phone":75,"phoneExt":38,"email":48},"02033158209",{"name":38,"role":46,"phone":47,"phoneExt":38,"email":38},{"name":78,"role":42,"phone":38,"phoneExt":38,"email":38},"Marta Boffito",{"facility":80,"status":52,"city":53,"state":38,"zip":38,"country":55,"countryCode":56,"cosmosGeoPoint":81,"geoPoint":83,"contacts":84},"Imperial College Healthcare NHS Trust",{"type":58,"coordinates":82},[60,61],{"lat":61,"lon":60},[85],{"name":86,"role":46,"phone":38,"phoneExt":38,"email":87},"Tara Tamang","tara.tamang@nhs.net",{"type":89,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR","100431020","phase-3-efficacy-of-doravirine--dolutegravir-dual-therapy-in-the-context-of-antiretroviral-therapy-switch-100431020",false,"NCT04892654","Efficacy of Doravirine + Dolutegravir Dual Therapy in the Context of Antiretroviral Therapy Switch","Efficacy of Doravirine + Dolutegravir Dual Therapy in the Context of Antiretroviral Therapy Switch (DORDOL)","DORDOL","Inclusion Criteria:\n\n* HIV-1 infected, 18 years or older\n* On stable \\& suppressive triple cART for at least 6 months\n* No evidence of resistance to DOR or DTG\n* No laboratory abnormalities, medical\u002Fpsychiatric conditions or alcohol\u002Fdrug use considered a barrier to participation by investigators\n* Women who are pre-menopausal and sexually active should be on one of the following methods of contraception:\n\n  * Implant\n  * Depot injection\n  * Intra-uterine device or system\n  * Oral hormonal contraception\n\nExclusion Criteria:\n\n* History of virological failure on an NNRTI in absence of a post-failure genotypic resistance test proving absence of resistance to DOR\n* History of virological failure on an INSTI in absence of a post-failure genotypic resistance test proving absence of resistance to DTG (INSTI mutations that will lead to the need of administering DTG twice-daily are considered as resistance to DTG - and the subject will be considered NOT eligible)\n* Concomitant medication contra-indicated with DTG or DOR\n* Haemoglobin \\\u003C9 g\u002FdL\n* Platelets \\\u003C80,000\u002Fmm3\n* Creatinine clearance \\\u003C30 mL\u002Fmin\n* AST or ALT ≥5N\n* Acute Hepatitis A infection.\n* Concomitant DAA for anti-HCV therapy\n* Known acute or chronic viral hepatitis B or C.\n\n  * Individuals testing positive for HBcAb, but negative HBsAg\u002FHBeAg, may be included on the trial.\n  * Individuals with positive anti-HCV results, but with HCV RNA not detected may be included on the trial.\n* Pregnant or breastfeeding women","ALL","18 Years",{"count":101,"type":102},150,"ESTIMATED","INTERVENTIONAL",[105],"PHASE3","Combination antiretroviral therapy (cART) HIV treatments are associated with increased quality of life, and a normalisation of life expectancy in people living with HIV. However, long-term use of cART can lead to side-effects through exposure to drug-related toxicity.\n\nFor this reason researchers are interested in looking at alternative therapies that might expose patients to fewer and less severe side effects while providing the same quality of care as antiretroviral therapies most often used to treat HIV.\n\nThe purpose of this study is to investigate if the study drug combination that is being tested (doravirine + dolutegravir) is safe compared with other triple cART regimens.",[108],"HIV-1-infection",[110,23,29,111],"HIV","cART","2023-10-24",{"date":114,"type":115},"2023-10-25","ACTUAL",{"date":117,"type":115},"2022-08-17",{"date":119,"type":102},"2027-11-30",{"name":5,"class":6},3]