Recruiting
Phase 4

Cabotegravir & Rilpivirine

Sponsor:

International Maternal Pediatric Adolescent AIDS Clinical Trials Group

Code:

NCT07637942

Conditions

HIV -1 Infection

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Every 4-week long-acting injectable cabotegravir and rilpivirine

Every 4-week long-acting injectable cabotegravir and rilpivirine

Study Details

Brief summary:

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.

Conditions

HIV -1 Infection

Study ID

NCT07637942

Start date

Oct 1, 2026

Status verified date

Nov, 2026

Completion date

Apr 22, 2028

Anticipated

Primary completion date

Apr 22, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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

experimental: 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

Interventions

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.

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.

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 ]
  • 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 [ Time Frame: Measured from study entry through six weeks postpartum ]

Central Contacts and Locations

Central contacts

Lisa Levy

2028848480LLEVY@FHI360.ORG

Locations

Site 5052, University of Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Lisa Abuogi, MD

303-358-5061Lisa.Abuogi@childrenscolorado.org

Site 4001, Lurie Children's Hospital of Chicago CRS

Recruiting

Chicago, Illinois, United States, 60614

Contacts

Jennifer Jao, MD, MPH

312-227-4080jjao@luriechildrens.org

Site 6201, University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

William Short, MD

267-971-3275william.short@pennmedicine.upenn.edu

Site 5128, Baylor College of Medicine/Texas Children's Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Mary Paul, MD

832-822-1038mpaul@bcm.edu

More Information

Sponsor

International Maternal Pediatric Adolescent AIDS Clinical Trials Group

Last update posted

Nov 3, 2026

Last verified

Nov, 2026

Keywords

  • HIV
  • Pregnancy
  • CAB LA + RPV LA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-04. This information was provided to ClinicalTrials.gov by International Maternal Pediatric Adolescent AIDS Clinical Trials Group on 2026-11-03. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.