[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100487711":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":44,"responsibleParty":66,"collaborators":68,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":42,"enrollmentInfo":81,"targetDuration":42,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":47,"whyStopped":42,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"University of Liverpool","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Delstrigo","EXPERIMENTAL","doravirine\u002Flamivudine\u002Ftenofovir disoproxil 100 mg\u002F 300 mg\u002F 245 mg film coated tablets, dosed 1 tablet once daily for the duration of the study",[13],"Drug: Doravirine",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of care","ACTIVE_COMPARATOR","dolutegravir\u002Flamivudine\u002Ftenofovir disoproxil 50 mg\u002F300 mg\u002F245 mg film coated tablets, dosed 1 tablet once daily for the duration of the study",[19],"Drug: Dolutegravir",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Doravirine","Fixed dose combination of doravirine, lamivudine and tenofovir disoproxil",[9],[9],{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Dolutegravir","Fixed dose combination of dolutegravir, lamivudine and tenofovir disoproxil",[15],[32],"TLD",[34],{"name":35,"affiliation":5,"role":36},"Saye Khoo","PRINCIPAL_INVESTIGATOR",[38],{"name":39,"role":40,"phone":41,"phoneExt":42,"email":43},"Helen Reynolds","CONTACT","+ 44 151 794 5553",null,"dorado@liverpool.ac.uk",[45],{"facility":46,"status":47,"city":48,"state":42,"zip":42,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Desmond Tutu Health Foundation","RECRUITING","Cape Town","South Africa","ZA",{"type":52,"coordinates":53},"Point",[54,55],18.42322,-33.92584,{"lat":55,"lon":54},[58,61,63],{"name":59,"role":40,"phone":42,"phoneExt":42,"email":60},"Alicia James","info@hiv-research.org.za",{"name":62,"role":36,"phone":42,"phoneExt":42,"email":42},"Lauren Jennings",{"name":64,"role":65,"phone":42,"phoneExt":42,"email":42},"Catherine Orrell","SUB_INVESTIGATOR",{"type":67,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR",[69,71],{"name":70,"class":6},"Liverpool School of Tropical Medicine",{"name":46,"class":6},"100487711","phase-4-doravirine-dose-optimisation-in-pregnancy-100487711",false,"NCT05630638","Doravirine Dose Optimisation in Pregnancy","DoraDO","Inclusion Criteria:\n\n* Women ≥ 18 years old\n* Ability to give informed consent prior to participation\n* Willing and able to comply with all study requirements\n* HIV positive\n* Pregnant (initiating cART ≥ 12 weeks and \\\u003C 26 weeks gestation)\n* Intention to breastfeed postpartum\n\nExclusion Criteria:\n\n* Received any cART in preceding 6 months\n* Chronic hepatitis B (HBV) infection with clinical evidence of transaminitis\n* Elevations in serum levels of alanine aminotransferase (ALT) \\> 5 times the upper limit of normal (ULN) or ALT \\> 3xULN and bilirubin \\>2xULN (with \\> 35 % direct bilirubin)\n* Previous documented failure of an NNRTI-containing cART regimen\n* Previous history of hypersensitivity to any ARV\n* Concomitant medication which are inducers of SoC and DOR metabolism (e.g. rifampicin, anti-epileptic agents, rifabutin, St John's Wort, mitotane, enzalutamide, lumacaftor). Contraindicated medications can be found on Liverpool Drug Interactions website (hiv-druginteractions.org)\n* Participants with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption cannot take DOR as the tablet contains lactose monohydrate\n* Clinical depression or clinical judgment suggests increased risk of suicidality","FEMALE","18 Years",{"count":82,"type":83},76,"ESTIMATED","INTERVENTIONAL",[86],"PHASE4","A randomised, open label, controlled PK standard of care vs doravirine plus 2 nucleoside reverse transcriptase inhibitors backbone in pregnant women initiating combination antiretroviral therapy in the second trimester of pregnancy.",[89],"HIV",[91],"Pregnancy","2026-02-17",{"date":94,"type":95},"2026-02-19","ACTUAL",{"date":97,"type":95},"2023-10-10",{"date":99,"type":83},"2028-07",{"name":5,"class":6},1]