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