[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642793":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":13,"centralContacts":18,"locations":24,"responsibleParty":177,"collaborators":179,"id":187,"slug":188,"hasResults":189,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":193,"eligibilityCriteria":194,"healthyVolunteers":189,"sex":195,"minAge":196,"maxAge":7,"enrollmentInfo":197,"targetDuration":7,"studyType":200,"phases":7,"briefSummary":201,"conditions":202,"keywords":204,"overallStatus":208,"whyStopped":7,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":218},{"fullName":5,"class":6},"International Maternal Pediatric Adolescent AIDS Clinical Trials Group","NETWORK",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DRUG","Every 4-week long-acting injectable cabotegravir and rilpivirine","Long-acting injectable cabotegravir and rilpivirine, initiated pre- or post-conception. Participants will receive these drugs as prescribed outside the study by their non-study clinical care provider",[14],{"name":15,"affiliation":16,"role":17},"Rachel Scott, MD, MPH","MedStar Washington Hospital Center & MedStar Health Research Institute","STUDY_CHAIR",[19],{"name":20,"role":21,"phone":22,"phoneExt":7,"email":23},"Lisa Levy","CONTACT","2028848480","LLEVY@FHI360.ORG",[25,43,57,72,87,102,117,132,147,162],{"facility":26,"status":7,"city":27,"state":28,"zip":29,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":38},"Site 4601, University of California, UC San Diego CRS","La Jolla","California","92093","United States","US",{"type":33,"coordinates":34},"Point",[35,36],-117.2742,32.84727,{"lat":36,"lon":35},[39],{"name":40,"role":21,"phone":41,"phoneExt":7,"email":42},"Stephen Spector, MD","858-534-7055","saspector@ucsd.edu",{"facility":44,"status":7,"city":45,"state":28,"zip":46,"country":30,"countryCode":31,"cosmosGeoPoint":47,"geoPoint":51,"contacts":52},"Site 5048, University of Southern California","Los Angeles","90033",{"type":33,"coordinates":48},[49,50],-118.24368,34.05223,{"lat":50,"lon":49},[53],{"name":54,"role":21,"phone":55,"phoneExt":7,"email":56},"Alice Stek, MD","323-226-3353","stek@usc.edu",{"facility":58,"status":7,"city":59,"state":60,"zip":61,"country":30,"countryCode":31,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Site 5052, University of Colorado","Aurora","Colorado","80045",{"type":33,"coordinates":63},[64,65],-104.83192,39.72943,{"lat":65,"lon":64},[68],{"name":69,"role":21,"phone":70,"phoneExt":7,"email":71},"Lisa Abuogi, MD","303-358-5061","Lisa.Abuogi@childrenscolorado.org",{"facility":73,"status":7,"city":74,"state":75,"zip":76,"country":30,"countryCode":31,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Site 5030, Emory University School of Medicine","Atlanta","Georgia","30322",{"type":33,"coordinates":78},[79,80],-84.38798,33.749,{"lat":80,"lon":79},[83],{"name":84,"role":21,"phone":85,"phoneExt":7,"email":86},"Martina Badell, MD","404-778-3401","mbadell@emory.edu",{"facility":88,"status":7,"city":89,"state":90,"zip":91,"country":30,"countryCode":31,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"Site 4001, Lurie Children's Hospital of Chicago CRS","Chicago","Illinois","60614",{"type":33,"coordinates":93},[94,95],-87.65005,41.85003,{"lat":95,"lon":94},[98],{"name":99,"role":21,"phone":100,"phoneExt":7,"email":101},"Jennifer Jao, MD, MPH","312-227-4080","jjao@luriechildrens.org",{"facility":103,"status":7,"city":104,"state":105,"zip":106,"country":30,"countryCode":31,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Site 5092, Johns Hopkins University","Baltimore","Maryland","21287",{"type":33,"coordinates":108},[109,110],-76.61219,39.29038,{"lat":110,"lon":109},[113],{"name":114,"role":21,"phone":115,"phoneExt":7,"email":116},"Allison Agwu, MD","410-614-3917","ageorg10@jhmi.edu",{"facility":118,"status":7,"city":119,"state":120,"zip":121,"country":30,"countryCode":31,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"Site 5013, Jacobi Medical Center Bronx","The Bronx","New York","10461",{"type":33,"coordinates":123},[124,125],-73.86641,40.84985,{"lat":125,"lon":124},[128],{"name":129,"role":21,"phone":130,"phoneExt":7,"email":131},"Andrew Wiznia, MD","718-918-4664","andrew.wiznia@einsteinmed.edu",{"facility":133,"status":7,"city":134,"state":135,"zip":136,"country":30,"countryCode":31,"cosmosGeoPoint":137,"geoPoint":141,"contacts":142},"Site 6201, University of Pennsylvania","Philadelphia","Pennsylvania","19104",{"type":33,"coordinates":138},[139,140],-75.16362,39.95238,{"lat":140,"lon":139},[143],{"name":144,"role":21,"phone":145,"phoneExt":7,"email":146},"William Short, MD","267-971-3275","william.short@pennmedicine.upenn.edu",{"facility":148,"status":7,"city":149,"state":150,"zip":151,"country":30,"countryCode":31,"cosmosGeoPoint":152,"geoPoint":156,"contacts":157},"Site 6501, St Jude Children's Research Hospital","Memphis","Tennessee","38105",{"type":33,"coordinates":153},[154,155],-90.04898,35.14953,{"lat":155,"lon":154},[158],{"name":159,"role":21,"phone":160,"phoneExt":7,"email":161},"Katherine Knapp, MD","901-595-4645","katherine.knapp@stjude.org",{"facility":163,"status":7,"city":164,"state":165,"zip":166,"country":30,"countryCode":31,"cosmosGeoPoint":167,"geoPoint":171,"contacts":172},"Site 5128, Baylor College of Medicine\u002FTexas Children's Hospital","Houston","Texas","77030",{"type":33,"coordinates":168},[169,170],-95.36327,29.76328,{"lat":170,"lon":169},[173],{"name":174,"role":21,"phone":175,"phoneExt":7,"email":176},"Mary Paul, MD","832-822-1038","mpaul@bcm.edu",{"type":178,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR",[180,183,185],{"name":181,"class":182},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",{"name":184,"class":182},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)",{"name":186,"class":182},"National Institute of Mental Health (NIMH)","100642793","cabotegravir--rilpivirine-antiretroviral-therapy-in-pregnancy-100642793",false,"NCT07637942","Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy","Phase IV Study of the Pharmacokinetics of Long-Acting Injectable Cabotegravir and Rilpivirine in Pregnant and Postpartum Women With HIV in the United States","CREATE","Inclusion Criteria:\n\n* Willing and able to provide written informed consent for study participation for self and infant\n* At screening, age 18 years or older\n* Has a viable, intrauterine, singleton pregnancy with fetal ultrasound with an estimated gestational age (EGA) between 10 0\u002F7 and 23 6\u002F7 weeks (inclusive) at entry\n* At entry, intending to deliver at a study-associated medical facility and remain in the geographic area of the study for the duration of anticipated follow-up\n* Was diagnosed with HIV prior to the current pregnancy\n* Has a documented plasma HIV RNA result less than 50 copies\u002FmL from a specimen collected within 28 days prior to entry\n* Has the following laboratory test results from a specimen collected within 28 days prior to entry (1) Grade 2 or lower platelets (greater than or equal to 50,000 cells\u002Fmm3 or greater than or equal to 50.00 x 109 cells\u002FL); (2) Grade 1 or lower ALT (less than 2.5 x upper limit of normal; (3) Grade 1 or lower aspartate aminotransferase (AST)\n* Received first dose of CAB LA + RPV LA prior to entry (before or after conception of the current pregnancy) and is expected to receive CAB LA + RPV LA on a Q4W schedule for the duration of study participation\n\nExclusion Criteria:\n\n* History of treatment\u002Fvirologic failure associated with documented or suspected viral resistance to CAB or RPV (including oral RPV)\n* Has any of the following (1) HIV Subtype A6; (2) History of hypersensitivity reaction (HSR), known or suspected allergy to drugs under study, or any other contraindication to CAB or RPV; (3) Current contraindication to IM injection such as a current inflammatory skin condition that compromises the safety of IM injections or a dermatological condition which may interfere with the interpretation of ISRs; (4) Current use or anticipated need of therapeutic anticoagulation; (5) History of known or suspected bleeding disorder; (6) Current severe hepatic impairment (Class C) as determined by Child-Pugh classification; (7) History of suicidal ideation or attempt within six months of entry; (8) History of unstable or poorly controlled seizure disorder; (9) Current tuberculosis infection; (10) Current cervical intraepithelial neoplasia (CIN) 2 or 3, or malignancy other than Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma\n* Has any of the following during the current pregnancy: (1) Abnormal placentation, including placenta previa (complete) and placenta accreta\u002Fincreta\u002Fpercreta; (2) Cervical cerclage\u002Fcervical incompetence; (3) Abnormal fetal anatomy\n* Had any of the following in a previous pregnancy: (1) Eclampsia\u002FHemolysis, Elevated Liver enzymes and Low Platelets (HELLP) syndrome; (2) Intrauterine fetal demise (EGA greater than 20 weeks) without known nonrecurrent etiology; (3) Spontaneous very preterm delivery (less than 32 weeks); (4) Very LBW (less than 1500 g); (5) Cervical or abdominal cerclage due to cervical incompetence\n* Receipt of any prohibited medication within seven days prior to entry\n* Enrolled in another clinical trial of an investigational agent, device, or vaccine that may impact the PK of CAB or RPV\n* Receipt of an investigational agent or chemotherapy within 30 days prior to study entry\n* Adult-participant or fetus has any condition, such as uncontrolled diabetes, hypertension, or other comorbidities, that, in the opinion of the site investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives","FEMALE","18 Years",{"count":198,"type":199},40,"ESTIMATED","OBSERVATIONAL","Phase IV, multi-site, open-label, non-randomized study of the pharmacokinetics (PK) of long-acting injectable cabotegravir and rilpivirine (CAB LA + RPV LA) during pregnancy and postpartum.",[203],"HIV -1 Infection",[205,206,207],"HIV","Pregnancy","CAB LA + RPV LA","NOT_YET_RECRUITING","2026-06-09",{"date":211,"type":212},"2026-06-10","ACTUAL",{"date":214,"type":199},"2026-07-15",{"date":216,"type":199},"2028-02-15",{"name":5,"class":6},10]