Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy

Part of paid clinical trials in La Jolla, California.

Sponsor
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Study ID
NCT07637942
Status
Not Yet Recruiting

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Conditions

  • HIV -1 Infection

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Every 4-week long-acting injectable cabotegravir and rilpivirine — DRUG
    Long-acting injectable cabotegravir and rilpivirine, initiated pre- or post-conception. Participants will receive these drugs as prescribed outside the study by their non-study clinical care provider

Study Details

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.

Key Dates

Start date
Jul 15, 2026
Status verified
Jun 2026
Primary completion
Feb 15, 2028
Completion
Feb 15, 2028

Study Design

Enrollment
40 participants (estimated)

Primary Outcome Measure

Population PK: geometric mean clearance of CAB and RPV in second trimester, third trimester, and postpartum derived from a population PK model [ Time Frame: Measured from study entry through six weeks postpartum ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Site 4601, University of California, UC San Diego CRSLa JollaCalifornia92093
Stephen Spector, MD
858-534-7055
Site 5048, University of Southern CaliforniaLos AngelesCalifornia90033
Alice Stek, MD
323-226-3353
Site 5052, University of ColoradoAuroraColorado80045
Lisa Abuogi, MD
303-358-5061
Site 5030, Emory University School of MedicineAtlantaGeorgia30322
Martina Badell, MD
404-778-3401
Site 4001, Lurie Children's Hospital of Chicago CRSChicagoIllinois60614
Jennifer Jao, MD, MPH
312-227-4080
Site 5092, Johns Hopkins UniversityBaltimoreMaryland21287
Allison Agwu, MD
410-614-3917
Site 5013, Jacobi Medical Center BronxThe BronxNew York10461
Andrew Wiznia, MD
718-918-4664
Site 6201, University of PennsylvaniaPhiladelphiaPennsylvania19104
William Short, MD
267-971-3275
Site 6501, St Jude Children's Research HospitalMemphisTennessee38105
Katherine Knapp, MD
901-595-4645
Site 5128, Baylor College of Medicine/Texas Children's HospitalHoustonTexas77030
Mary Paul, MD
832-822-1038

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