[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07637942":3,"trial-entities:NCT07637942":263,"trial-summary:NCT07637942":267},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":27,"interventions":30,"primary_outcomes":35,"secondary_outcomes":41,"sex":93,"minimum_age":94,"maximum_age":25,"healthy_volunteers":95,"eligibility_criteria":96,"std_ages":116,"locations":119,"central_contacts":251,"overall_officials":256,"references":261,"see_also_links":262},"NCT07637942","IMPAACT 2050","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","NOT_YET_RECRUITING","2028-02-15","2026-06","2026-06-10","2026-07-15","International Maternal Pediatric Adolescent AIDS Clinical Trials Group","NETWORK",true,"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.","Up to 40 adult-participants with HIV viral suppression will be enrolled, in pairs with their infants, to achieve 30 evaluable adult-participants overall. The study will include women who initiated CAB LA + RPV LA outside the study, prior to study entry, either pre-conception (including on the day of conception) or post-conception.",[19],"HIV -1 Infection",[21,22,23],"HIV","Pregnancy","CAB LA + RPV LA","OBSERVATIONAL",null,[],{"count":28,"type":29},40,"ESTIMATED",[31],{"type":32,"name":33,"description":34},"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",[36,39],{"measure":37,"description":37,"timeFrame":38},"Population PK: geometric mean clearance of CAB and RPV in second trimester, third trimester, and postpartum derived from a population PK model","Measured from study entry through six weeks postpartum",{"measure":40,"description":40,"timeFrame":38},"Geometric mean pharmacokinetic trough of CAB and RPV from every 4 week (Q4W) CAB LA and RPV LA measured every 4 weeks in plasma in second trimester, third trimester, and postpartum",[42,45,48,52,55,58,60,62,65,68,71,75,78,81,84,87,89],{"measure":43,"description":43,"timeFrame":44},"Percentage of adult participants with HIV RNA less than 50 copies\u002FmL at delivery","Delivery",{"measure":46,"description":47,"timeFrame":38},"Percentage of adult participants with virologic escape","Percentage of adult participants with virologic escape, defined as a single measurement of HIV RNA greater than or equal to 200 copies\u002FmL",{"measure":49,"description":50,"timeFrame":51},"Percentage of adult participants with confirmed virologic failure","Percentage of adult participants with confirmed virologic failure, defined as two successive HIV RNA test results greater than or equal to 200 copies\u002FmL from separate specimens collected at least two weeks apart","Through 6 weeks postpartum",{"measure":53,"description":54,"timeFrame":51},"Number of adult participants with HIV resistance to CAB or RPV who had confirmed virologic failure","Number of adult participants with HIV resistance to CAB or RPV using IAS-USA, in participants who experienced confirmed virologic failure",{"measure":56,"description":56,"timeFrame":57},"Number of infant participants with perinatal transmission","Birth and six weeks post-birth",{"measure":59,"description":59,"timeFrame":38},"Percentage of adult participants with at least one Grade 3 or higher adverse event",{"measure":61,"description":61,"timeFrame":38},"Percentage of adult participants with at least one serious adverse event",{"measure":63,"description":63,"timeFrame":64},"Percentage of infant participants with at least one serious adverse event","Measured from birth through six weeks post-birth",{"measure":66,"description":67,"timeFrame":51},"Percentage of adult participants with spontaneous abortion","Percentage of adult participants with spontaneous abortion less than 20 weeks gestation",{"measure":69,"description":70,"timeFrame":51},"Percentage of adult participants with fetal demise\u002Fstillbirth","Percentage of adult participants with fetal demise\u002Fstillbirth, at greater than or equal to 20 weeks gestation",{"measure":72,"description":73,"timeFrame":74},"Percentage of infant participants born small for gestational age","Percentage of infant participants born small for gestational age, where birthweight is less than 10th percentile for sex and gestational age assigned at birth, based on Intergrowth 21st Standards","Birth",{"measure":76,"description":77,"timeFrame":74},"Percentage of infant participants with low birth weight","Percentage of infant participants with low birth weight, defined as less than 2500 grams",{"measure":79,"description":80,"timeFrame":74},"Percentage of infant participants born preterm","Percentage of infant participants born preterm, defined as less than 37 weeks gestation",{"measure":82,"description":83,"timeFrame":51},"Percentage of mother-infant pairs with occurrence of any adverse pregnancy outcome","Percentage of mother-infant pairs with occurrence of any adverse pregnancy outcome. Outcomes include: spontaneous abortion (\\\u003C20 weeks gestation), stillbirth (≥20 weeks gestation), preterm delivery (\\\u003C37 gestational weeks), small for gestational age (\\\u003C10th percentile per INTERGROWTH 21st Standards), or neonatal death",{"measure":85,"description":86,"timeFrame":74},"Percentage of infant participants with a congenital anomaly","Percentage of infant participants with a congenital anomaly based on the Metropolitan Atlanta Congenital Defects Program (MACDP) definition of defect",{"measure":88,"description":88,"timeFrame":64},"Percentage of infant deaths",{"measure":90,"description":91,"timeFrame":92},"Percentage of adult participants who would recommend CAB LA and RPV LA injections for other people living with HIV during pregnancy","Percentage of adult participants who would recommend CAB LA and RPV LA injections","Six weeks postpartum","FEMALE","18 Years",false,{"inclusion":97,"exclusion":106,"raw_text":115},[98,99,100,101,102,103,104,105],"Willing and able to provide written informed consent for study participation for self and infant","At screening, age 18 years or older","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","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","Was diagnosed with HIV prior to the current pregnancy","Has a documented plasma HIV RNA result less than 50 copies\u002FmL from a specimen collected within 28 days prior to entry","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)","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",[107,108,109,110,111,112,113,114],"History of treatment\u002Fvirologic failure associated with documented or suspected viral resistance to CAB or RPV (including oral RPV)","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","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","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","Receipt of any prohibited medication within seven days prior to entry","Enrolled in another clinical trial of an investigational agent, device, or vaccine that may impact the PK of CAB or RPV","Receipt of an investigational agent or chemotherapy within 30 days prior to study entry","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","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",[117,118],"ADULT","OLDER_ADULT",[120,135,147,160,173,186,199,212,225,238],{"facility":121,"city":122,"state":123,"zip":124,"country":125,"contacts":126,"geoPoint":132},"Site 4601, University of California, UC San Diego CRS","La Jolla","California","92093","United States",[127],{"name":128,"role":129,"phone":130,"email":131},"Stephen Spector, MD","CONTACT","858-534-7055","saspector@ucsd.edu",{"lat":133,"lon":134},32.84727,-117.2742,{"facility":136,"city":137,"state":123,"zip":138,"country":125,"contacts":139,"geoPoint":144},"Site 5048, University of Southern California","Los Angeles","90033",[140],{"name":141,"role":129,"phone":142,"email":143},"Alice Stek, MD","323-226-3353","stek@usc.edu",{"lat":145,"lon":146},34.05223,-118.24368,{"facility":148,"city":149,"state":150,"zip":151,"country":125,"contacts":152,"geoPoint":157},"Site 5052, University of Colorado","Aurora","Colorado","80045",[153],{"name":154,"role":129,"phone":155,"email":156},"Lisa Abuogi, MD","303-358-5061","Lisa.Abuogi@childrenscolorado.org",{"lat":158,"lon":159},39.72943,-104.83192,{"facility":161,"city":162,"state":163,"zip":164,"country":125,"contacts":165,"geoPoint":170},"Site 5030, Emory University School of Medicine","Atlanta","Georgia","30322",[166],{"name":167,"role":129,"phone":168,"email":169},"Martina Badell, MD","404-778-3401","mbadell@emory.edu",{"lat":171,"lon":172},33.749,-84.38798,{"facility":174,"city":175,"state":176,"zip":177,"country":125,"contacts":178,"geoPoint":183},"Site 4001, Lurie Children's Hospital of Chicago CRS","Chicago","Illinois","60614",[179],{"name":180,"role":129,"phone":181,"email":182},"Jennifer Jao, MD, MPH","312-227-4080","jjao@luriechildrens.org",{"lat":184,"lon":185},41.85003,-87.65005,{"facility":187,"city":188,"state":189,"zip":190,"country":125,"contacts":191,"geoPoint":196},"Site 5092, Johns Hopkins University","Baltimore","Maryland","21287",[192],{"name":193,"role":129,"phone":194,"email":195},"Allison Agwu, MD","410-614-3917","ageorg10@jhmi.edu",{"lat":197,"lon":198},39.29038,-76.61219,{"facility":200,"city":201,"state":202,"zip":203,"country":125,"contacts":204,"geoPoint":209},"Site 5013, Jacobi Medical Center Bronx","The Bronx","New York","10461",[205],{"name":206,"role":129,"phone":207,"email":208},"Andrew Wiznia, MD","718-918-4664","andrew.wiznia@einsteinmed.edu",{"lat":210,"lon":211},40.84985,-73.86641,{"facility":213,"city":214,"state":215,"zip":216,"country":125,"contacts":217,"geoPoint":222},"Site 6201, University of Pennsylvania","Philadelphia","Pennsylvania","19104",[218],{"name":219,"role":129,"phone":220,"email":221},"William Short, MD","267-971-3275","william.short@pennmedicine.upenn.edu",{"lat":223,"lon":224},39.95238,-75.16362,{"facility":226,"city":227,"state":228,"zip":229,"country":125,"contacts":230,"geoPoint":235},"Site 6501, St Jude Children's Research Hospital","Memphis","Tennessee","38105",[231],{"name":232,"role":129,"phone":233,"email":234},"Katherine Knapp, MD","901-595-4645","katherine.knapp@stjude.org",{"lat":236,"lon":237},35.14953,-90.04898,{"facility":239,"city":240,"state":241,"zip":242,"country":125,"contacts":243,"geoPoint":248},"Site 5128, Baylor College of Medicine\u002FTexas Children's Hospital","Houston","Texas","77030",[244],{"name":245,"role":129,"phone":246,"email":247},"Mary Paul, MD","832-822-1038","mpaul@bcm.edu",{"lat":249,"lon":250},29.76328,-95.36327,[252],{"name":253,"role":129,"phone":254,"email":255},"Lisa Levy","2028848480","LLEVY@FHI360.ORG",[257],{"name":258,"affiliation":259,"role":260},"Rachel Scott, MD, MPH","MedStar Washington Hospital Center & MedStar Health Research Institute","STUDY_CHAIR",[],[],{"nct_id":4,"conditions":264,"biomarkers":266},[265,22],"HIV Infection",[265],{"nct_id":4,"found":95,"summary":25,"prompt_version":25}]