protocolSection identificationModule nctId: NCT06336434, orgStudyIdInfo id: IMPAACT 2040, briefTitle: CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-24, primaryCompletionDateStruct date: 2026-12-24, completionDateStruct date: 2026-12-24, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: National Institute of Allergy and Infectious Diseases (NIAID), class: NIH, descriptionModule briefSummary: This is a Phase I/II, multicenter, open-label, non-randomized study with four groups to characterize the pharmacokinetics and safety of Cabotegravir (CAB) and Rilpivirine (RPV) long-acting injectable (LA) during pregnancy and postpartum among people with HIV-1 viral suppression and their infants., conditionsModule conditions: HIV-1-infection, conditions: Pregnancy, conditions: Postpartum, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: CAB LA 600mg, interventions name: RPV LA 900mg, interventions name: CAB LA 400mg, interventions name: RPV LA 600mg, outcomesModule primaryOutcomes measure: PK trough of CAB LA measured in plasma in pregnancy and postpartum, primaryOutcomes measure: Percentage of adults with at least one Grade 3 or higher adverse event in pregnancy and through 18 weeks postpartum, primaryOutcomes measure: Percentage of adults with at least one serious adverse event in pregnancy and through 18 weeks postpartum, secondaryOutcomes measure: PK trough measured in plasma in pregnancy and postpartum, secondaryOutcomes measure: Percentage of adults with HIV-1 RNA less than 50 copies/mL at delivery, secondaryOutcomes measure: Percentage of adults with HIV-1 RNA less than 50 copies/mL at delivery using the standardized FDA snapshot algorithm, secondaryOutcomes measure: Percentage of adults with virologic escape (single measurement of greater than or equal to 200 copies/mL) from study entry through pregnancy and through 18 weeks postpartum, secondaryOutcomes measure: Percentage of adults with confirmed virologic failure through 18 weeks postpartum, secondaryOutcomes measure: Number of adults with HIV-1 resistance to CAB and/or RPV using IAS-USA in participants who experience confirmed virologic failure, assessed at entry and time of failure, secondaryOutcomes measure: Number of infants with HIV-1 infection, secondaryOutcomes measure: Percentage of infants at least one Grade 3 or higher adverse event through 18 weeks post-birth, secondaryOutcomes measure: Percentage of infants at least one serious adverse event through 18 weeks post-birth, secondaryOutcomes measure: Percentage of infants with a congenital anomaly consistent with the Metropolitan Atlanta Congenital Defects Program (MACDP) definition of defect, secondaryOutcomes measure: Percentage of deaths among infants, secondaryOutcomes measure: Percentage of adults with a spontaneous abortion (less than 20 weeks gestation), secondaryOutcomes measure: Percentage of adults with a fetal demise/stillbirth (greater than or equal to 20 weeks gestation), secondaryOutcomes measure: Percentage of neonatal deaths (within 28 days of life) among infants, secondaryOutcomes measure: Percentage of infants born small for gestational age (SGA) at < 10th percentile, secondaryOutcomes measure: Percentage of infants born with low birth weight < 2500 g, secondaryOutcomes measure: Percentage of infants born preterm < 37 weeks gestation, secondaryOutcomes measure: Percentage of adult-infant participant pairs with any adverse pregnancy outcome of spontaneous abortion, fetal demise/stillbirth, neonatal death, SGA, or preterm delivery, secondaryOutcomes measure: CAB and RPV plasma concentrations in infants exposed to CAB LA + RPV LA during pregnancy and via chest/breastfeeding, secondaryOutcomes measure: Percentage of adults who discontinued injections prior to receiving the full course of injections due to intolerability of injection, secondaryOutcomes measure: Frequency of CAB LA + RPV LA injections received, secondaryOutcomes measure: Percentage of adults willing to continue CAB LA + RPV LA postpartum and/or in future pregnancies, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Site 4601, University of California, UC San Diego CRS- Mother-Child-Adolescent HIV Program, city: La Jolla, state: California, zip: 92093-0672, country: United States, contacts name: Megan Loughran, BA, role: CONTACT, phone: 858-534-9218, email: meloughran@health.ucsd.edu, geoPoint lat: 32.84727, lon: -117.2742, locations facility: Site 5048, University of Southern California LA, city: Los Angeles, state: California, zip: 90033, country: United States, contacts name: Lourdes Topete, role: CONTACT, phone: 323-865-1585, email: ltopete@usc.edu, geoPoint lat: 34.05223, lon: -118.24368, locations facility: Site 5092, Johns Hopkins University, Baltimore, city: Baltimore, state: Maryland, zip: 21287, country: United States, contacts name: Amanda Haines, role: CONTACT, phone: 443-287-8950, email: ahaines8@jhmi.edu, geoPoint lat: 39.29038, lon: -76.61219, locations facility: Site 5013, Jacobi Medical Center Bronx, city: Bronx, state: New York, zip: 10461, country: United States, contacts name: Marlene Burey, NP, role: CONTACT, phone: 718-918-4783, email: marlene.burey@nychhc.org, geoPoint lat: 40.84985, lon: -73.86641, locations facility: Site 8051 - Wits RHI Shandukani Research Centre, city: Johannesburg, zip: 2001, country: South Africa, contacts name: Rorisang Komane, BNS, role: CONTACT, phone: +27-72-933-4002, email: rkomane@wrhi.ac.za, geoPoint lat: -26.20227, lon: 28.04363, locations facility: Site 8052, Soweto, city: Johannesburg, country: South Africa, contacts name: Ntatule Ndiweni, role: CONTACT, phone: +27-11-989-9748, email: ndiwenih@phru.co.za, geoPoint lat: -26.20227, lon: 28.04363, locations facility: Site 8950, FAMCRU CRS, city: Parow, zip: 7505, country: South Africa, contacts name: Jeanne de Jager, MSc, role: CONTACT, phone: +27-21-938-4290, email: jeannes@sun.ac.za, geoPoint lat: -33.89723, lon: 18.59992, locations facility: Site 30300, Umlazi Clinical Research Site, city: Umlazi, zip: 4066, country: South Africa, contacts name: Zukiswa Godlwana, role: CONTACT, phone: +27-31-2601998, email: zukiswa.godlwana@caprisa.org, geoPoint lat: -29.96572, lon: 30.88639, hasResults: False