[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100487711":3},{"organization":4,"outcomesModule":7,"designInfo":56,"detailedDescription":65,"studyPopulation":59,"armGroups":66,"interventions":79,"overallOfficials":92,"centralContacts":96,"locations":102,"responsibleParty":124,"collaborators":126,"id":130,"slug":59,"hasResults":131,"nctId":132,"briefTitle":133,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":131,"sex":136,"minAge":137,"maxAge":59,"enrollmentInfo":138,"targetDuration":59,"studyType":141,"phases":142,"briefSummary":144,"conditions":145,"keywords":147,"overallStatus":105,"whyStopped":59,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":158},{"fullName":5,"class":6},"University of Liverpool","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":22,"otherOutcomes":41},[9,13,16,19],{"measure":10,"description":11,"timeFrame":12},"AUC of doravirine in pregnant women","Pharmacokinetic parameters of doravirine in pregnancy - AUC","24 to 28 weeks gestation, 32 to 36 weeks gestation, 6 weeks postpartum",{"measure":14,"description":15,"timeFrame":12},"Cmax of doravirine in pregnant women","Pharmacokinetic parameters of doravirine in pregnancy - Cmax",{"measure":17,"description":18,"timeFrame":12},"Cmin of doravirine in pregnant women","Pharmacokinetic parameters of doravirine in pregnancy - Cmin",{"measure":20,"description":21,"timeFrame":12},"CL\u002FF of doravirine in pregnant women","Pharmacokinetic parameters of doravirine in pregnancy - CL\u002FF",[23,27,30,34,38],{"measure":24,"description":25,"timeFrame":26},"To assess the number of treatment related adverse events by DAIDS v2.1","Safety and tolerability of doravirine in mothers and neonates","Until study completion, a maximum of 13 months",{"measure":28,"description":29,"timeFrame":12},"To determine the concentration of doravirine in breastmilk, in breastfed infants, in genital tract, cord blood","Pharmacokinetics of doravirine in various compartments",{"measure":31,"description":32,"timeFrame":33},"To assess maternal viral load responses","Viral load assessment","Delivery and 6 months postpartum",{"measure":35,"description":36,"timeFrame":37},"To determine infant transmissions in the first 6 months of life using HIV viral load","Assessment of perinatal transmission using HIV viral load","Delivery until 6 months postpartum",{"measure":39,"description":40,"timeFrame":26},"To assess the prevalence or emergence of HIV drug resistance by determining HIV mutations","Assessment of drug resistance tests",[42,46,49,53],{"measure":43,"description":44,"timeFrame":45},"Viral dynamics in the genital tract of mothers","Assessment of viral load in the genital tract","Baseline and 32 to 36 weeks gestation",{"measure":47,"description":48,"timeFrame":45},"PK in the genital tract of mothers","Assessment of drug concentrations in the genital tract",{"measure":50,"description":51,"timeFrame":52},"PK of DOR in breastmilk, breastfed infants and in the genital tract","Assessment of drug concentrations in non-plasma compartments","Delivery, 6 weeks postpartum and 24 weeks postpartum",{"measure":54,"description":40,"timeFrame":55},"Prevalence or emergence of HIV drug resistance by determining HIV mutations","Baseline to 24 weeks postpartum",{"allocation":57,"interventionModel":58,"interventionModelDescription":59,"primaryPurpose":60,"observationalModel":59,"timePerspective":59,"maskingInfo":61},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":62,"maskingDescription":59,"whoMasked":63},"SINGLE",[64],"OUTCOMES_ASSESSOR","Women diagnosed HIV positive in the second trimester of pregnancy in South Africa will be enrolled and randomised 1:1 to receive standard of care or doravirine plus 2 NRTI backbone. Participants will receive study treatment until delivery and up to 28 weeks postpartum, with a maximum total of 14 months of study treatment. Given the high prevalence of NNRTI resistance, alternative ARV treatment options are essential. Doravirine is licenced for the treatment of HIV-1 in adults in North America and Europe. Whilst the efficacy and safety of doravirine has been established in non-pregnant adults, there are no adequate human data available to establish whether DOR poses a risk to pregnancy outcomes. It is important to have data on the safety and pharmacokinetics of the drug during pregnancy and in particularly the third trimester of pregnancy in order to support its use. The hypothesis for this study is that pregnancy influences the pharmacokinetics of doravirine when initiated in the second trimester.",[67,73],{"label":68,"type":69,"description":70,"interventionNames":71},"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",[72],"Drug: Doravirine",{"label":74,"type":75,"description":76,"interventionNames":77},"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",[78],"Drug: Dolutegravir",[80,86],{"type":81,"name":82,"description":83,"armGroupLabels":84,"otherNames":85},"DRUG","Doravirine","Fixed dose combination of doravirine, lamivudine and tenofovir disoproxil",[68],[68],{"type":81,"name":87,"description":88,"armGroupLabels":89,"otherNames":90},"Dolutegravir","Fixed dose combination of dolutegravir, lamivudine and tenofovir disoproxil",[74],[91],"TLD",[93],{"name":94,"affiliation":5,"role":95},"Saye Khoo","PRINCIPAL_INVESTIGATOR",[97],{"name":98,"role":99,"phone":100,"phoneExt":59,"email":101},"Helen Reynolds","CONTACT","+ 44 151 794 5553","dorado@liverpool.ac.uk",[103],{"facility":104,"status":105,"city":106,"state":59,"zip":59,"country":107,"countryCode":108,"cosmosGeoPoint":109,"geoPoint":114,"contacts":115},"Desmond Tutu Health Foundation","RECRUITING","Cape Town","South Africa","ZA",{"type":110,"coordinates":111},"Point",[112,113],18.42322,-33.92584,{"lat":113,"lon":112},[116,119,121],{"name":117,"role":99,"phone":59,"phoneExt":59,"email":118},"Alicia James","info@hiv-research.org.za",{"name":120,"role":95,"phone":59,"phoneExt":59,"email":59},"Lauren Jennings",{"name":122,"role":123,"phone":59,"phoneExt":59,"email":59},"Catherine Orrell","SUB_INVESTIGATOR",{"type":125,"investigatorFullName":59,"investigatorTitle":59,"investigatorAffiliation":59,"oldNameTitle":59,"oldOrganization":59},"SPONSOR",[127,129],{"name":128,"class":6},"Liverpool School of Tropical Medicine",{"name":104,"class":6},"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":139,"type":140},76,"ESTIMATED","INTERVENTIONAL",[143],"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.",[146],"HIV",[148],"Pregnancy","2026-02-17",{"date":151,"type":152},"2026-02-19","ACTUAL",{"date":154,"type":152},"2023-10-10",{"date":156,"type":140},"2028-07",{"name":5,"class":6},1]