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Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy (CREATE)

26 de agosto de 2026 atualizado 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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 estudo

Observacional

Inscrição (Estimado)

40

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • Estados Unidos
    • California
      • La Jolla, California, Estados Unidos, 92093
        • Site 4601, University of California, UC San Diego CRS
        • Contato:
      • Los Angeles, California, Estados Unidos, 90033
        • Site 5048, University of Southern California
        • Contato:
          • Alice Stek, MD
          • Número de telefone: 323-226-3353
          • E-mail: stek@usc.edu
    • Colorado
      • Aurora, Colorado, Estados Unidos, 80045
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30322
        • Site 5030, Emory University School of Medicine
        • Contato:
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60614
        • Site 4001, Lurie Children's Hospital of Chicago CRS
        • Contato:
    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21287
        • Site 5092, Johns Hopkins University
        • Contato:
    • New York
      • The Bronx, New York, Estados Unidos, 10461
    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19104
    • Tennessee
      • Memphis, Tennessee, Estados Unidos, 38105
        • Site 6501, St Jude Children's Research Hospital
        • Contato:
    • Texas
      • Houston, Texas, Estados Unidos, 77030
        • Site 5128, Baylor College of Medicine/Texas Children's Hospital
        • Contato:
          • Mary Paul, MD
          • Número de telefone: 832-822-1038
          • E-mail: mpaul@bcm.edu

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

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.

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Population PK: geometric mean clearance of CAB and RPV in second trimester, third trimester, and postpartum derived from a population PK model
Prazo: 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
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Percentage of adult participants with HIV RNA less than 50 copies/mL at delivery
Prazo: Delivery
Percentage of adult participants with HIV RNA less than 50 copies/mL at delivery
Delivery
Percentage of adult participants with virologic escape
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Birth
Percentage of infant participants with low birth weight, defined as less than 2500 grams
Birth
Percentage of infant participants born preterm
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Six weeks postpartum
Percentage of adult participants who would recommend CAB LA and RPV LA injections
Six weeks postpartum

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

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

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

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

15 de outubro de 2026

Conclusão Primária (Estimado)

22 de março de 2028

Conclusão do estudo (Estimado)

22 de março de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

27 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

9 de junho de 2026

Primeira postagem (Real)

10 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

27 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

26 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • IMPAACT 2050
  • UM1AI068632 (Concessão/Contrato do NIH dos EUA)
  • UM1AI068616 (Concessão/Contrato do NIH dos EUA)
  • UM1AI106716 (Concessão/Contrato do NIH dos EUA)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

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

Prazo de Compartilhamento de 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.

Critérios de acesso de compartilhamento 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 informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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