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Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy (CREATE)

26 sierpnia 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

40

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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.

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Population PK: geometric mean clearance of CAB and RPV in second trimester, third trimester, and postpartum derived from a population PK model
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Percentage of adult participants with HIV RNA less than 50 copies/mL at delivery
Ramy czasowe: Delivery
Percentage of adult participants with HIV RNA less than 50 copies/mL at delivery
Delivery
Percentage of adult participants with virologic escape
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Birth
Percentage of infant participants with low birth weight, defined as less than 2500 grams
Birth
Percentage of infant participants born preterm
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Six weeks postpartum
Percentage of adult participants who would recommend CAB LA and RPV LA injections
Six weeks postpartum

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

International Maternal Pediatric Adolescent AIDS Clinical Trials Group

Współpracownicy

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)

Śledczy

  • Krzesło do nauki: Rachel Scott, MD, MPH, MedStar Washington Hospital Center & MedStar Health Research Institute

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

15 października 2026

Zakończenie podstawowe (Szacowany)

22 marca 2028

Ukończenie studiów (Szacowany)

22 marca 2028

Daty rejestracji na studia

Pierwszy przesłany

27 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

9 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

10 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

27 sierpnia 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

26 sierpnia 2026

Ostatnia weryfikacja

1 sierpnia 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • IMPAACT 2050
  • UM1AI068632 (Grant/umowa NIH USA)
  • UM1AI068616 (Grant/umowa NIH USA)
  • UM1AI106716 (Grant/umowa NIH USA)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

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

Ramy czasowe udostępniania 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.

Kryteria dostępu do udostępniania 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.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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