[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638694":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":48,"responsibleParty":203,"collaborators":206,"id":210,"slug":211,"hasResults":212,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":216,"eligibilityCriteria":217,"healthyVolunteers":212,"sex":218,"minAge":219,"maxAge":43,"enrollmentInfo":220,"targetDuration":43,"studyType":223,"phases":224,"briefSummary":226,"conditions":227,"keywords":229,"overallStatus":232,"whyStopped":43,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":242},{"fullName":5,"class":6},"Fundación Huésped","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental","EXPERIMENTAL","Dolutegravir plus Lamivudine DOVATO: Dolutegravir 50mg\u002Flamivudine 300 mg, FDC, 1 coformulated tablet QD",[13],"Drug: Dolutegravir\u002FLamivudine 50 MG-300 MG Oral Tablet [DOVATO]",{"label":15,"type":16,"description":17,"interventionNames":18},"Active Comparator","ACTIVE_COMPARATOR","TDF\u002FXTC or TAF\u002FFTC plus Dolutegravir (XTC stands for lamivudine OR emtricitabine)\n\n* TDF\u002FFTC 300\u002F200 mg, 1 coformulated tablet QD (FDC) plus Dolutegravir 50 mg, 1 tablet QD OR\n* TDF\u002F3TC 300\u002F300 mg, 1 coformulated tablet QD (FDC) plus Dolutegravir 50 mg, 1 tablet QD\n* TAF\u002FFTC 25\u002F200 MG, 1 tablet QD (FDC) plus Dolutegravir 50 mg, 1 tablet QD",[19],"Drug: TDF\u002FXTC or TAF\u002FFTC plus Dolutegravir (XTC stand for lamivudine OR emtricitabine)",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Dolutegravir\u002FLamivudine 50 MG-300 MG Oral Tablet [DOVATO]","1 pill QD",[9],[27],"BI-THERAPY",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"TDF\u002FXTC or TAF\u002FFTC plus Dolutegravir (XTC stand for lamivudine OR emtricitabine)","1 pill of each QD",[15],[33],"Triple therapy",[35],{"name":36,"affiliation":5,"role":37},"Pedro Enrinque Cahn, MD","PRINCIPAL_INVESTIGATOR",[39,45],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},"María Inés Figueroa, MD","CONTACT","+541149817777",null,"maria.figueroa@huesped.org.ar",{"name":46,"role":41,"phone":42,"phoneExt":43,"email":47},"Emanuel Dell'Isola, Mr.","emanuel.dellisola@huesped.org.ar",[49,62,76,87,103,122,144,155,172,188],{"facility":50,"status":43,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":43,"geoPoint":43,"contacts":56},"Hospital General de Agudos Dr. Cosme Argerich","Ciudad Autónoma de Buenos Aires","Buenos Aires","C1155AHD","Argentina","AR",[57,61],{"name":58,"role":41,"phone":59,"phoneExt":43,"email":60},"Diego Cecchini, MD","+54911 54976263","diegocec@gmail.com",{"name":58,"role":37,"phone":43,"phoneExt":43,"email":43},{"facility":63,"status":43,"city":51,"state":52,"zip":64,"country":54,"countryCode":55,"cosmosGeoPoint":43,"geoPoint":43,"contacts":65},"Sanatorio Güemes","C1188AAF",[66,70,75],{"name":67,"role":41,"phone":68,"phoneExt":43,"email":69},"Verónica Lacal, MD","+54 9 11 58296259","verolacal@gmail.com",{"name":71,"role":41,"phone":72,"phoneExt":73,"email":74},"Sebastián Nuñez, MD","+54 11 4959-8200","8384 \u002F 8365","snunez@fsg.edu.ar",{"name":67,"role":37,"phone":43,"phoneExt":43,"email":43},{"facility":77,"status":43,"city":51,"state":52,"zip":78,"country":54,"countryCode":55,"cosmosGeoPoint":43,"geoPoint":43,"contacts":79},"Hospital de Agudos J.A. Fernandez","C1425AGP",[80,84,86],{"name":81,"role":41,"phone":82,"phoneExt":43,"email":83},"María José Rolón, MD","+54 011 48082627","fernandez_infectologia@buenosaires.gob.ar",{"name":85,"role":41,"phone":82,"phoneExt":43,"email":83},"José MD, Barletta",{"name":81,"role":37,"phone":43,"phoneExt":43,"email":43},{"facility":88,"status":43,"city":89,"state":52,"zip":90,"country":54,"countryCode":55,"cosmosGeoPoint":91,"geoPoint":96,"contacts":97},"Hospital Nacional Profesor Alejandro Posadas","El Palomar","B1684",{"type":92,"coordinates":93},"Point",[94,95],-58.60153,-34.61771,{"lat":95,"lon":94},[98,102],{"name":99,"role":41,"phone":100,"phoneExt":43,"email":101},"Mariana Golikow, MD","+54 9 11 3803-1126","marugolikow@gmail.com",{"name":99,"role":37,"phone":43,"phoneExt":43,"email":43},{"facility":104,"status":43,"city":105,"state":52,"zip":106,"country":54,"countryCode":55,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Hospital de Agudos Paroissien","Isidro Casanova","B1765",{"type":92,"coordinates":108},[109,110],-58.58745,-34.7,{"lat":110,"lon":109},[113,117,121],{"name":114,"role":41,"phone":115,"phoneExt":43,"email":116},"Pablo Garnica, MD","+54 9 15-5958-4516","andrespablo451@hotmail.com",{"name":118,"role":41,"phone":119,"phoneExt":43,"email":120},"Eduardo Warley, MD","+54 011 1541897181","eduwarley@yahoo.com.ar",{"name":114,"role":37,"phone":43,"phoneExt":43,"email":43},{"facility":123,"status":43,"city":124,"state":125,"zip":126,"country":127,"countryCode":128,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"Fundação Bahiana de Infectologia","Salvador","Estado de Bahia","40110-160","Brazil","BR",{"type":92,"coordinates":130},[131,132],-38.49096,-12.97563,{"lat":132,"lon":131},[135,139,143],{"name":136,"role":41,"phone":137,"phoneExt":43,"email":138},"Carlos Brites, MD","+55 71 99232-9552","crbrites@gmail.com",{"name":140,"role":41,"phone":141,"phoneExt":43,"email":142},"Anne Kettley Lacerda de L. Gonzaga, RN","+55 (71) 3646-3561","annegonzaga.fbai@outlook.com",{"name":136,"role":37,"phone":43,"phoneExt":43,"email":43},{"facility":145,"status":43,"city":146,"state":147,"zip":148,"country":127,"countryCode":128,"cosmosGeoPoint":43,"geoPoint":43,"contacts":149},"Complexo do Hospital de Clínicas da UFPR\u002FEbserh","Curitiba","Pernambuco","80430-000",[150,154],{"name":151,"role":41,"phone":152,"phoneExt":43,"email":153},"Monica Maria Gomes da Silva, MD","41-999951285","monica.gomez@ufpr.br",{"name":151,"role":37,"phone":43,"phoneExt":43,"email":43},{"facility":156,"status":43,"city":157,"state":158,"zip":159,"country":127,"countryCode":128,"cosmosGeoPoint":160,"geoPoint":164,"contacts":165},"Hospital Geral de Nova Iguaçu","Nova Iguaçu","Rio de Janeiro","26030-380",{"type":92,"coordinates":161},[162,163],-43.45111,-22.75917,{"lat":163,"lon":162},[166,171],{"name":167,"role":41,"phone":168,"phoneExt":169,"email":170},"Aline Santos Ramalho Teixeira Benevenuto, MD","+55 21 35132812","295","alineramalhopesquisa@gmail.com",{"name":167,"role":37,"phone":43,"phoneExt":43,"email":43},{"facility":173,"status":43,"city":174,"state":175,"zip":176,"country":127,"countryCode":128,"cosmosGeoPoint":177,"geoPoint":181,"contacts":182},"Universidade Federal do Rio Grande do Norte","Natal","Rio Grande do Norte","59075-070",{"type":92,"coordinates":178},[179,180],-35.20944,-5.795,{"lat":180,"lon":179},[183,187],{"name":184,"role":41,"phone":185,"phoneExt":43,"email":186},"Monica Bay, MD","+55 84 994141921","monicabay@gmail.com",{"name":184,"role":37,"phone":43,"phoneExt":43,"email":43},{"facility":189,"status":43,"city":190,"state":190,"zip":191,"country":127,"countryCode":128,"cosmosGeoPoint":192,"geoPoint":196,"contacts":197},"RDSS - Ricardo Sobhie Diaz & Cia Solucoes Cientificas Ltda - Ricardo Diaz Scientific Solution","São Paulo","04037-030",{"type":92,"coordinates":193},[194,195],-46.63611,-23.5475,{"lat":195,"lon":194},[198,202],{"name":199,"role":41,"phone":200,"phoneExt":43,"email":201},"Ricardo Sobhie Diaz, MD","+55(21)99799-4412","daniele.lunacunha@ricardodiaz.com.br",{"name":199,"role":37,"phone":43,"phoneExt":43,"email":43},{"type":37,"investigatorFullName":204,"investigatorTitle":205,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"Maria Ines Figueroa","Principal Investigator",[207],{"name":208,"class":209},"ViiV Healthcare","INDUSTRY","100638694","phase-4-dolutegravirlamivudine-in-treatment-nave-pregnant-women-100638694",false,"NCT07616739","Dolutegravir\u002FLamivudine in Treatment-Naïve Pregnant Women","Evaluating the Efficacy and Safety of Dolutegravir\u002FLamivudine (DTG\u002F3TC) in ART-Naïve Pregnant Women","PREDUAL","Inclusion Criteria:\n\nAll persons who are eligible must meet all of the following:\n\n1. Confirmed HIV-1 infection: All tests must use blood, serum, or plasma samples. Documentation may be obtained from medical records. HIV-1 positive is defined as having HIV-1 RNA in plasma ≥ 1000 copies\u002FmL, plus one antibody test or two positive HIV antibody tests (two different rapid tests or one rapid test and one positive ELISA\u002FEIE test). If any of these diagnostic test results are not available, they will be performed at the SCR visit. In all cases, an HIV viral load test will be performed.\n2. Not exposed to prior antiretroviral therapy (ART): No prior antiretroviral therapy, including exposure to PrEP and\u002For PEP in the last 6 months.\n3. Ability to sign the informed consent form.\n4. Plasma HIV-1 RNA ≥1000 copies\u002FmL. Viral load from the last 30 days may be valid. . Age ≥ 16 years or older in Argentina, ≥ 15 years or older in Brazil. The participant must be of the age required in their country of residence to give legal informed consent. Otherwise, informed consent must be signed by a parent or legal guardian, according to country guidelines, in addition to the participant.\n\n6\\. Pregnant at any gestational age up to 32 weeks at the time of the screening visit: Viable pregnancy with a gestational age ≤32 weeks, defined according to menstrual history and\u002For ultrasound. Note: If the menstrual history is unknown or if there is a discrepancy between the menstrual history and the ultrasound, the gestational age will be determined based on the best technology available at each center.\n\n7\\. The participant intends to continue with the pregnancy.\n\nExclusion Criteria:\n\nAll eligible individuals must NOT meet any of the following criteria:\n\n1. Documented resistance to 3TC (presence of the M184V\u002FI mutation) or DTG (defined as the presence of G118R, Q148 H\u002FK\u002FR, or R263K).\n2. Active hepatitis C infection. 3. Active hepatitis B (HBsAg positive or detectable HBV viral load in cases with isolated positive HBV anti-core).\n3. Hemoglobin \\\u003C8 g\u002FdL.\n4. Fetal abnormalities detected on ultrasound\n5. Concomitant medications required with possible drug interactions specified in section 5.10.\n6. ALT \\>=5 times the ULN, or ALT \\>=3xULN and bilirubin \\>=1.5xULN (with \\>35% direct bilirubin). Participants with severe hepatic impairment (Class C) as determined by Child-Pugh classification\n7. Presence of severe preeclampsia or other pregnancy-related events, in current or previous pregnancies, such as renal or hepatic abnormalities (grade 2 or higher proteinuria, elevated serum creatinine, CrCl \\\u003C50 mL\u002Fmin, total bilirubin, ALT, or AST).\n8. Active opportunistic infection at screening: active severe opportunistic infections and\u002For severe bacterial infection, including active tuberculosis or severe disease or unstable clinical condition within 14 days prior to study entry.\n9. Any patient or disease-related condition that, in the investigator's opinion, would prevent the patient from adhering to study medication or complying with study visits or procedures.\n10. Problematic drug and\u002For alcohol use, which in the opinion of the site investigator could interfere with therapeutic compliance with study requirements.\n11. Known allergy or sensitivity to any of the study medications or their formulations.\n12. Vomiting or any other reason generating inability to swallow medications due to a pre-existing active disorder that prevents proper swallowing and absorption of study medications.\n13. Creatinine Clearance of \\\u003C30 mL\u002Fmin . If a creatinine value was obtained within 30 days prior to the screening visit, it may be used to calculate the CrCl.","FEMALE","15 Years",{"count":221,"type":222},210,"ESTIMATED","INTERVENTIONAL",[225],"PHASE4","Protocol Number: FH-94\n\nStudy Objetives:\n\nPrimary:\n\n* To evaluate the virological response to Dolutegravir\u002FLamivudine in naive pregnant women with HIV who are starting antiretroviral therapy and vertical transmission in exposed neonates.\n\nSecondary:\n\n* To evaluate the incidence of maternal adverse events.\n* To evaluate perinatal outcomes at delivery.\n* To evaluate maximum virological suppression at delivery.\n* To evaluate the incidence of changes in body weight exceeding what is expected for gestation.\n* To evaluate the immune response based on changes in CD4, CD8, and CD4\u002FCD8 ratio values during pregnancy.\n* Assess baseline resistance and the development of resistance to virological failure to integrase inhibitors and INTRs during treatment with DTG+3TC or DTG+TDF\u002FXTC or DTG+TAF\u002FFTC.\n* To evaluate the incidence of HIV infection in children that breastfeed.\n* To evaluate safety outcomes and virological response of DTG+3TC compared to DTG+TDF\u002FXTC or DTG+TAF\u002FFTC.\n\nExploratory:\n\n* To explore the non-inferiority of DTG+3TC therapy compared to DTG+TDF\u002FXTC or DTG+TAF\u002FFTC treatment.\n* To evaluate the frequency of antiretroviral therapy withdrawal or modification before delivery.",[228],"HIV-1-infection",[230,231],"antiretroviral naive triple therapy","Dolutegravir-Lamivudine dual-therapy","NOT_YET_RECRUITING","2026-05-27",{"date":235,"type":236},"2026-06-01","ACTUAL",{"date":238,"type":222},"2026-06-15",{"date":240,"type":222},"2028-09-15",{"name":5,"class":6},10]