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NCT07637942

Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy

Not Yet Recruiting
Not specifiedAges 18+Observational
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
~40 participants
Updated 2026-06-10 on ClinicalTrials.gov
What's tested:Every 4-week long-acting injectable cabotegravir and rilpivirine

At a glance

Recruiting sites
0 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Population PK: geometric mean clearance of CAB and RPV in second trimester, third trimester, and postpartum derived from a population PK model
Measured over Measured from study entry through six weeks postpartum
+1 more outcome measured

Conditions

HIV -1 Infection

Explore related trials

HIV InfectionPregnancyHIV Infection

Where it's being run

10 sites across 9 states
California2
Colorado1
Georgia1
Illinois1
Maryland1
New York1
Pennsylvania1
Tennessee1

Study leadership

  • Rachel Scott, MD, MPH · STUDY_CHAIR · MedStar Washington Hospital Center & MedStar Health Research Institute

Who to contact

Lisa Levy
[email protected]
2028848480
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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Population PK: geometric mean clearance of CAB and RPV in second trimester, third trimester, and postpartum derived from a population PK modelMeasured 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

  • 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 postpartumMeasured 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