Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy

NCT07637942 | Not Yet Recruiting DMC FDA Drug

• 4 other identifiers: IMPAACT 2050UM1AI068632UM1AI068616UM1AI106716
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 10

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

Keywords

HIV; Pregnancy; CAB LA + RPV LA

Outcome Measures

Primary Outcomes (2)

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

  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

  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

Secondary Outcomes (17)

• Percentage of adult participants with HIV RNA less than 50 copies/mL at delivery

  Delivery

• Percentage of adult participants with virologic escape

  Measured from study entry through six weeks postpartum

• Percentage of adult participants with confirmed virologic failure

  Through 6 weeks postpartum

• Number of adult participants with HIV resistance to CAB or RPV who had confirmed virologic failure

  Through 6 weeks postpartum

• Number of infant participants with perinatal transmission

  Birth and six weeks post-birth

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• International Maternal Pediatric Adolescent AIDS Clinical Trials Group: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (10)

Site 4601, University of California, UC San Diego CRS

La Jolla, California, 92093, United States

Location

Site 5048, University of Southern California

Los Angeles, California, 90033, United States

Location

Site 5052, University of Colorado

Aurora, Colorado, 80045, United States

Location

Site 5030, Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

Site 4001, Lurie Children's Hospital of Chicago CRS

Chicago, Illinois, 60614, United States

Location

Site 5092, Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Site 5013, Jacobi Medical Center Bronx

The Bronx, New York, 10461, United States

Location

Site 6201, University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Site 6501, St Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

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

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

Rilpivirine

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Rachel Scott, MD, MPH

  MedStar Washington Hospital Center & MedStar Health Research Institute

  STUDY CHAIR

Central Study Contacts

Lisa Levy

CONTACT

2028848480; LLEVY@FHI360.ORG

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 10, 2026
• Study Start (Estimated): July 15, 2026
• Primary Completion (Estimated): February 15, 2028
• Study Completion (Estimated): February 15, 2028
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 3 months following publication and available throughout period of funding of the International Maternal Pediatric Adolescent AIDS Clinical Trial (IMPAACT) Network by NIH.
• Access Criteria: * 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.

Locations

US (10)