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Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy (CREATE)

2 ноября 2026 г. обновлено: 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.

Обзор исследования

Статус

Рекрутинг

Условия

Вмешательство/лечение

Подробное описание

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.

Тип исследования

Интервенционный

Регистрация (Оцененный)

40

Фаза

  • Фаза 4

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Lisa Levy
  • Номер телефона: 2028848480
  • Электронная почта: LLEVY@FHI360.ORG

Места учебы

  • Соединенные Штаты
    • California
      • La Jolla, California, Соединенные Штаты, 92093
        • Еще не набирают
        • Site 4601, University of California, UC San Diego CRS
        • Контакт:
          • Stephen Spector, MD
          • Номер телефона: 858-534-7055
          • Электронная почта: saspector@ucsd.edu
      • Los Angeles, California, Соединенные Штаты, 90033
        • Еще не набирают
        • Site 5048, University of Southern California
        • Контакт:
          • Alice Stek, MD
          • Номер телефона: 323-226-3353
          • Электронная почта: stek@usc.edu
    • Colorado
      • Aurora, Colorado, Соединенные Штаты, 80045
        • Рекрутинг
        • Site 5052, University of Colorado
        • Контакт:
    • Georgia
      • Atlanta, Georgia, Соединенные Штаты, 30322
        • Еще не набирают
        • Site 5030, Emory University School of Medicine
        • Контакт:
          • Martina Badell, MD
          • Номер телефона: 404-778-3401
          • Электронная почта: mbadell@emory.edu
    • Illinois
      • Chicago, Illinois, Соединенные Штаты, 60614
        • Рекрутинг
        • Site 4001, Lurie Children's Hospital of Chicago CRS
        • Контакт:
          • Jennifer Jao, MD, MPH
          • Номер телефона: 312-227-4080
          • Электронная почта: jjao@luriechildrens.org
    • Maryland
      • Baltimore, Maryland, Соединенные Штаты, 21287
        • Еще не набирают
        • Site 5092, Johns Hopkins University
        • Контакт:
          • Allison Agwu, MD
          • Номер телефона: 410-614-3917
          • Электронная почта: ageorg10@jhmi.edu
    • New York
      • The Bronx, New York, Соединенные Штаты, 10461
        • Еще не набирают
        • Site 5013, Jacobi Medical Center Bronx
        • Контакт:
    • Pennsylvania
      • Philadelphia, Pennsylvania, Соединенные Штаты, 19104
        • Рекрутинг
        • Site 6201, University of Pennsylvania
        • Контакт:
    • Tennessee
      • Memphis, Tennessee, Соединенные Штаты, 38105
        • Еще не набирают
        • Site 6501, St Jude Children's Research Hospital
        • Контакт:
    • Texas
      • Houston, Texas, Соединенные Штаты, 77030
        • Рекрутинг
        • Site 5128, Baylor College of Medicine/Texas Children's Hospital
        • Контакт:
          • Mary Paul, MD
          • Номер телефона: 832-822-1038
          • Электронная почта: mpaul@bcm.edu

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

18 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Женский

Описание

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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Нерандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: CAB LA + RPV LA Initiation Pre Conception

Pregnant women with controlled HIV who were using CAB LA + RPV LA pre-conception, and continue to receive Q4W CAB LA + RPV LA
Лекарство: Every 4-week long-acting injectable cabotegravir and rilpivirine

Long-acting injectable cabotegravir and rilpivirine, initiated pre-conception. Participants will receive these drugs as prescribed outside the study by their non-study clinical care provider.

Лекарство: Every 4-week long-acting injectable cabotegravir and rilpivirine

Long-acting injectable cabotegravir and rilpivirine, initiated post-conception. Participants will receive these drugs as prescribed outside the study by their non-study clinical care provider.
Экспериментальный: CAB LA + RPV LA Initiation Post Conception

Pregnant women with controlled HIV who switch from oral SOC and initiate Q4W CAB LA + RPV LA post-conception, and continue to receive CAB LA + RPV LA
Лекарство: Every 4-week long-acting injectable cabotegravir and rilpivirine

Long-acting injectable cabotegravir and rilpivirine, initiated pre-conception. Participants will receive these drugs as prescribed outside the study by their non-study clinical care provider.

Лекарство: Every 4-week long-acting injectable cabotegravir and rilpivirine

Long-acting injectable cabotegravir and rilpivirine, initiated post-conception. Participants will receive these drugs as prescribed outside the study by their non-study clinical care provider.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Population PK: geometric mean clearance of CAB and RPV in second trimester, third trimester, and postpartum derived from a population PK model
Временное ограничение: 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
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Percentage of adult participants with HIV RNA less than 50 copies/mL at delivery
Временное ограничение: Delivery

Percentage of adult participants with HIV RNA less than 50 copies/mL at delivery
Delivery
Percentage of adult participants with virologic escape
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: Birth

Percentage of infant participants with low birth weight, defined as less than 2500 grams
Birth
Percentage of infant participants born preterm
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: Six weeks postpartum

Percentage of adult participants who would recommend CAB LA and RPV LA injections
Six weeks postpartum

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

International Maternal Pediatric Adolescent AIDS Clinical Trials Group

Соавторы

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)

Следователи

  • Учебный стул: Rachel Scott, MD, MPH, MedStar Washington Hospital Center & MedStar Health Research Institute

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

1 октября 2026 г.

Первичное завершение (Оцененный)

22 апреля 2028 г.

Завершение исследования (Оцененный)

22 апреля 2028 г.

Даты регистрации исследования

Первый отправленный

27 мая 2026 г.

Впервые представлено, что соответствует критериям контроля качества

9 июня 2026 г.

Первый опубликованный (Действительный)

10 июня 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

3 ноября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

2 ноября 2026 г.

Последняя проверка

1 ноября 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • IMPAACT 2050
  • UM1AI068632 (Грант/контракт NIH США)
  • UM1AI068616 (Грант/контракт NIH США)
  • UM1AI106716 (Грант/контракт NIH США)

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

ДА

Описание плана IPD

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

Сроки обмена 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.

Критерии совместного доступа к 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.

Совместное использование IPD Поддерживающий тип информации

  • STUDY_PROTOCOL
  • САП

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Да

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

продукт, произведенный в США и экспортированный из США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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