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Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy (CREATE)

26. august 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

40

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Population PK: geometric mean clearance of CAB and RPV in second trimester, third trimester, and postpartum derived from a population PK model
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

International Maternal Pediatric Adolescent AIDS Clinical Trials Group

Samarbejdspartnere

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)

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

15. oktober 2026

Primær færdiggørelse (Anslået)

22. marts 2028

Studieafslutning (Anslået)

22. marts 2028

Datoer for studieregistrering

Først indsendt

27. maj 2026

Først indsendt, der opfyldte QC-kriterier

9. juni 2026

Først opslået (Faktiske)

10. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IMPAACT 2050
  • UM1AI068632 (U.S. NIH-bevilling/kontrakt)
  • UM1AI068616 (U.S. NIH-bevilling/kontrakt)
  • UM1AI106716 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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

IPD-delingstidsramme

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

IPD-delingsadgangskriterier

  • 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.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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