[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"International Maternal Pediatric Adolescent AIDS Clinical Trials Group\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":91},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,43,69],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"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":20,"type":21},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.",[25],"HIV -1 Infection",[27,28,29],"HIV","Pregnancy","CAB LA + RPV LA","NOT_YET_RECRUITING","2026-06-09",{"date":33,"type":34},"2026-06-10","ACTUAL",{"date":36,"type":21},"2026-07-15",{"date":38,"type":21},"2028-02-15",{"name":40,"class":41},"International Maternal Pediatric Adolescent AIDS Clinical Trials Group","NETWORK",10,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":51,"minAge":4,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"100615511","understanding-practices-of-lactation-and-infant-feeding-together-with-women-with-hiv-in-the-united-states-100615511","NCT07293559","Understanding Practices of Lactation and Infant Feeding Together With Women With HIV in the United States","UPLIFT","Core Activity 1 Inclusion Criteria: Pregnant and Postpartum Women with HIV\n\n* Is of legal age or circumstance to provide independent informed consent\n* Belongs to one of the following five categories:\n\n  * Is pregnant with a gestational age of 28 0\u002F7 to 37 6\u002F7 weeks at entry and is considering breastfeeding\n  * Is pregnant with a gestational age of 28 0\u002F7 to 37 6\u002F7 weeks at entry and is not considering breastfeeding\n  * Gave birth to a live born infant after 28 February 2023, is over 4 weeks postpartum, did not breastfeed for any duration and has no intent to breastfeed\n  * Gave birth to a live born infant after 28 February 2023, is over 4 weeks postpartum, breastfed for less than four weeks, and has weaned\n  * Gave birth to a live born infant after 28 February 2023, is over 4 weeks postpartum, and breastfed for four weeks or longer\n* Diagnosed with HIV prior to or during the pregnancy\n* If preferred language is other than English, is willing to participate in interviews with an available translator.\n\nCore Activity 1 Inclusion Criteria: Healthcare Providers and Ancillary Healthcare Professionals\n\n* Is of legal age or circumstance to provide independent informed consent\n* Is a healthcare provider who self-identifies as an obstetrician, midwife, nurse, adult or pediatric infectious disease specialist, or advance practice provider who participated in the care of at least five PPWH and\u002For their infants over the three years prior to entry OR\n* Is an ancillary healthcare professional who self-identifies as a social worker, lactation support provider, patient navigator, pharmacist, doula who participated in the care of at least five PPWH and\u002For their infants over the three years prior to entry\n\nCore Activity 1 Inclusion Criteria: Influential Individuals\n\n* Has been identified by a PPWH enrolled in Core Activity 1 as aware of her HIV status and contributing to her infant feeding decisions\n* Is of legal age or circumstance to provide independent informed consent\n* If preferred language is other than English, is willing to participate in interviews with an available translator.\n\nCore Activity 2 Inclusion Criteria: Pregnant and Postpartum Women with HIV and their Infant\n\n* Is of legal age or circumstance to provide independent informed consent\n* Is pregnant with singleton fetus with a gestational age of ≥ 28 0\u002F7 weeks at entry OR\n* Gave birth to a live born, singleton infant up to 7 days prior to entry\n* Diagnosed with HIV prior to or during the pregnancy\n* Expected to be available for the duration of follow-up\n\nCore Activity 3 Inclusion Criteria: Breastfeeding Postpartum Women with HIV and their Infant\n\n* Is of legal age or circumstance to provide independent informed consent\n* Must be up to 7 days postpartum with live-born infant\n* Diagnosed with HIV prior to or during the pregnancy\n* Breastfed her infant for any duration\n\nCore Activity 3 Inclusion Criteria: Pilot Registry Testers\n\n* Is of legal age or circumstance to provide independent informed consent\n* Working at a healthcare facility that provides care for women with HIV who are breastfeeding and\u002For their infants\n\nExclusion Criteria: Core Activities 1-3\n\n* Has any condition identified during the screening period that, in the opinion of site investigator, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives",true,"ALL",{"count":53,"type":21},1150,"IMPAACT 2046\u002FUPLIFT (Understanding Practices of Lactation and Infant Feeding decisions Together with women with HIV) is a multi-site, mixed-methods, observational cohort study. The purpose of the study is to explore infant feeding preferences, practices, and outcomes among mothers with HIV and their families in the United States. It will employ both qualitative and quantitative research methods to address existing knowledge gaps and to understand the clinical, behavioral, and social factors influencing infant feeding decisions. As part of the study's mixed method approach, a longitudinal cohort study of mothers and their infants will be established. The study also aims to pilot a national registry of breastfeeding women living with HIV in the United States.",[56,57,58],"HIV-1-infection","Breastfeeding","Pregnancy Related","RECRUITING","2026-03-25",{"date":62,"type":34},"2026-03-27",{"date":64,"type":34},"2026-02-24",{"date":66,"type":21},"2031-04-24",{"name":40,"class":41},11,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":78,"conditions":79,"keywords":80,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":84,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},"100608924","study-of-ceftriaxone-and-benzathine-penicillin-g-during-pregnancy-100608924","NCT07207876","Study of Ceftriaxone and Benzathine Penicillin G During Pregnancy","Phase IV Study of the Pharmacokinetics and Safety of Ceftriaxone and Benzathine Penicillin G During Pregnancy","Inclusion Criteria:\n\n* Is of legal age or circumstance to provide independent informed consent as determined by site standard operating procedures (SOPs) and consistent with Institutional Review Board (IRB) policies and procedures and is willing and able to provide written informed consent for her own and, if applicable (Arm 2), her infant's study participation\n* At screening, has a viable singleton intrauterine pregnancy of any gestational age confirmed by fetal ultrasound, as determined by the site investigator based on medical records, with trimester documented based on the best available obstetric estimate\n* At screening, is receiving or expected to receive one of the following drugs under study as prescribed by a clinical care provider and documented in medical records:\n\n  * Ceftriaxone: IV or IM administration for an indication other than syphilis\n  * Benzathine penicillin G: IM administration for treatment of syphilis\n* At entry, expects to remain in the geographic area of the study site during pregnancy and at least 30 days postpartum\n\nExclusion Criteria:\n\n* Previously enrolled in this study\n* Requires desensitization to ceftriaxone or benzathine penicillin G as determined by the site investigator based on pregnant participant report and available medical records\n* Has any of the following as determined by the site investigator based on pregnant participant report and available medical records:\n\n  * Current indication for hemodialysis\n  * Current indication for intensive care unit hospitalization\n  * Creatinine (Cr) ≥ 3.5 x upper limit of normal (ULN) at any time during the current pregnancy and\u002For chronic kidney disease Stage 5\n* Receipt of any of the following prohibited medications within seven days prior to entry as determined by the site investigator based on pregnant participant report and available medical records:\n\n  * Probenecid\n  * Penicillin\n* Arm 1A: any penicillin\n* Arm 1B: any penicillin\n* Arm 2: penicillin other than benzathine penicillin G\n\n  * Benzapril\n  * Chlorpropamide\n  * Diflunisal\n  * Irbesartan\n  * Ketoprofen\n  * Ketorolac tromethamine\n  * Meclofenamic acid\n  * Mefenamic acid\n  * Oxaprozin\n  * Parecoxib\n  * Penciclovir\n  * Pioglitazone\n  * Telmisartan\n  * Valsartan\n* Receipt of any investigational agent within seven days prior to entry as determined by the site investigator based on pregnant participant report and available medical records\n* Has any documented or suspected clinically significant condition 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 study objectives",{"count":77,"type":21},110,"IMPAACT 2044 is a study to characterize the pharmacokinetics (PK) and safety of ceftriaxone and benzathine penicillin G during pregnancy. Up to 78 pregnant women receiving (1) ceftriaxone for indications other than syphilis or (2) benzathine penicillin G for treatment of syphilis from non-study clinical care providers will be enrolled at study sites located in the United States. Approximately 22 infants of pregnant participants receiving benzathine penicillin G will also be enrolled.",[28],[81,82,28,83],"Cefriaxone","Syphilis","Benzathine Penicillin G",{"date":62,"type":34},{"date":86,"type":34},"2026-02-16",{"date":88,"type":21},"2027-05-17",{"name":40,"class":41},9,""]