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Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy (CREATE)

26 de agosto de 2026 actualizado por: International Maternal Pediatric Adolescent AIDS Clinical Trials Group

Phase IV Study of the Pharmacokinetics of Long-Acting Injectable Cabotegravir and Rilpivirine in Pregnant and Postpartum Women With HIV in the United States

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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Estimado)

40

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Lisa Levy
  • Número de teléfono: 2028848480
  • Correo electrónico: LLEVY@FHI360.ORG

Ubicaciones de estudio

  • Estados Unidos
    • California
      • La Jolla, California, Estados Unidos, 92093
        • Site 4601, University of California, UC San Diego CRS
        • Contacto:
          • Stephen Spector, MD
          • Número de teléfono: 858-534-7055
          • Correo electrónico: saspector@ucsd.edu
      • Los Angeles, California, Estados Unidos, 90033
        • Site 5048, University of Southern California
        • Contacto:
          • Alice Stek, MD
          • Número de teléfono: 323-226-3353
          • Correo electrónico: stek@usc.edu
    • Colorado
      • Aurora, Colorado, Estados Unidos, 80045
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30322
        • Site 5030, Emory University School of Medicine
        • Contacto:
          • Martina Badell, MD
          • Número de teléfono: 404-778-3401
          • Correo electrónico: mbadell@emory.edu
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60614
        • Site 4001, Lurie Children's Hospital of Chicago CRS
        • Contacto:
    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21287
        • Site 5092, Johns Hopkins University
        • Contacto:
          • Allison Agwu, MD
          • Número de teléfono: 410-614-3917
          • Correo electrónico: ageorg10@jhmi.edu
    • New York
      • The Bronx, New York, Estados Unidos, 10461
        • Site 5013, Jacobi Medical Center Bronx
        • Contacto:
    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19104
    • Tennessee
      • Memphis, Tennessee, Estados Unidos, 38105
        • Site 6501, St Jude Children's Research Hospital
        • Contacto:
    • Texas
      • Houston, Texas, Estados Unidos, 77030
        • Site 5128, Baylor College of Medicine/Texas Children's Hospital
        • Contacto:
          • Mary Paul, MD
          • Número de teléfono: 832-822-1038
          • Correo electrónico: mpaul@bcm.edu

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra no probabilística

Población de estudio

Pregnant women with HIV viral suppression in the United States, age 18 years and older, who initiated CAB LA + RPV LA pre- or post-conception, with an estimated gestational age from 10 0/7 weeks through 23 6/7 weeks at time of entry, and their infants.

Descripción

Inclusion Criteria:

  • 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 0/7 and 23 6/7 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/mL 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/mm3 or greater than or equal to 50.00 x 109 cells/L); (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

Exclusion Criteria:

  • History of treatment/virologic 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/increta/percreta; (2) Cervical cerclage/cervical incompetence; (3) Abnormal fetal anatomy
  • Had any of the following in a previous pregnancy: (1) Eclampsia/Hemolysis, 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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Population PK: geometric mean clearance of CAB and RPV in second trimester, third trimester, and postpartum derived from a population PK model
Periodo de tiempo: Measured from study entry through six weeks postpartum
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
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
Periodo de tiempo: Measured from study entry through six weeks postpartum
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
Measured from study entry through six weeks postpartum

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of adult participants with HIV RNA less than 50 copies/mL at delivery
Periodo de tiempo: Delivery
Percentage of adult participants with HIV RNA less than 50 copies/mL at delivery
Delivery
Percentage of adult participants with virologic escape
Periodo de tiempo: Measured from study entry through six weeks postpartum
Percentage of adult participants with virologic escape, defined as a single measurement of HIV RNA greater than or equal to 200 copies/mL
Measured from study entry through six weeks postpartum
Percentage of adult participants with confirmed virologic failure
Periodo de tiempo: Through 6 weeks postpartum
Percentage of adult participants with confirmed virologic failure, defined as two successive HIV RNA test results greater than or equal to 200 copies/mL from separate specimens collected at least two weeks apart
Through 6 weeks postpartum
Number of adult participants with HIV resistance to CAB or RPV who had confirmed virologic failure
Periodo de tiempo: Through 6 weeks postpartum
Number of adult participants with HIV resistance to CAB or RPV using IAS-USA, in participants who experienced confirmed virologic failure
Through 6 weeks postpartum
Number of infant participants with perinatal transmission
Periodo de tiempo: Birth and six weeks post-birth
Number of infant participants with perinatal transmission
Birth and six weeks post-birth
Percentage of adult participants with at least one Grade 3 or higher adverse event
Periodo de tiempo: Measured from study entry through six weeks postpartum
Percentage of adult participants with at least one Grade 3 or higher adverse event
Measured from study entry through six weeks postpartum
Percentage of adult participants with at least one serious adverse event
Periodo de tiempo: Measured from study entry through six weeks postpartum
Percentage of adult participants with at least one serious adverse event
Measured from study entry through six weeks postpartum
Percentage of infant participants with at least one serious adverse event
Periodo de tiempo: Measured from birth through six weeks post-birth
Percentage of infant participants with at least one serious adverse event
Measured from birth through six weeks post-birth
Percentage of adult participants with spontaneous abortion
Periodo de tiempo: Through 6 weeks postpartum
Percentage of adult participants with spontaneous abortion less than 20 weeks gestation
Through 6 weeks postpartum
Percentage of adult participants with fetal demise/stillbirth
Periodo de tiempo: Through 6 weeks postpartum
Percentage of adult participants with fetal demise/stillbirth, at greater than or equal to 20 weeks gestation
Through 6 weeks postpartum
Percentage of infant participants born small for gestational age
Periodo de tiempo: Birth
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
Percentage of infant participants with low birth weight
Periodo de tiempo: Birth
Percentage of infant participants with low birth weight, defined as less than 2500 grams
Birth
Percentage of infant participants born preterm
Periodo de tiempo: Birth
Percentage of infant participants born preterm, defined as less than 37 weeks gestation
Birth
Percentage of mother-infant pairs with occurrence of any adverse pregnancy outcome
Periodo de tiempo: Through 6 weeks postpartum
Percentage of mother-infant pairs with occurrence of any adverse pregnancy outcome. Outcomes include: spontaneous abortion (<20 weeks gestation), stillbirth (≥20 weeks gestation), preterm delivery (<37 gestational weeks), small for gestational age (<10th percentile per INTERGROWTH 21st Standards), or neonatal death
Through 6 weeks postpartum
Percentage of infant participants with a congenital anomaly
Periodo de tiempo: Birth
Percentage of infant participants with a congenital anomaly based on the Metropolitan Atlanta Congenital Defects Program (MACDP) definition of defect
Birth
Percentage of infant deaths
Periodo de tiempo: Measured from birth through six weeks post-birth
Percentage of infant deaths
Measured from birth through six weeks post-birth
Percentage of adult participants who would recommend CAB LA and RPV LA injections for other people living with HIV during pregnancy
Periodo de tiempo: Six weeks postpartum
Percentage of adult participants who would recommend CAB LA and RPV LA injections
Six weeks postpartum

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

International Maternal Pediatric Adolescent AIDS Clinical Trials Group

Colaboradores

National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Mental Health (NIMH)

Investigadores

  • Silla de estudio: Rachel Scott, MD, MPH, MedStar Washington Hospital Center & MedStar Health Research Institute

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

15 de octubre de 2026

Finalización primaria (Estimado)

22 de marzo de 2028

Finalización del estudio (Estimado)

22 de marzo de 2028

Fechas de registro del estudio

Enviado por primera vez

27 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

9 de junio de 2026

Publicado por primera vez (Actual)

10 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

27 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

26 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • IMPAACT 2050
  • UM1AI068632 (Subvención/contrato del NIH de EE. UU.)
  • UM1AI068616 (Subvención/contrato del NIH de EE. UU.)
  • UM1AI106716 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

Individual participant data that underlie results in the publication, after deidentification.

Marco de tiempo para compartir IPD

Beginning 3 months following publication and available throughout period of funding of the International Maternal Pediatric Adolescent AIDS Clinical Trial (IMPAACT) Network by NIH.

Criterios de acceso compartido de IPD

  • With whom? Researchers who provide a methodologically sound proposal for use of the data that is approved by the IMPAACT Network.
  • For what types of analyses? To achieve aims in the proposal approved by the IMPAACT Network.
  • By what mechanism will data be made available? Researchers may submit a request for access to data using the IMPAACT "Data Request" form at: https://www.impaactnetwork.org/studies/submit-research-proposal. Researchers of approved proposals will need to sign an IMPAACT Data Use Agreement before receiving the data.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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