Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy
United States40 participantsStarted 2026-07-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is focused on studying how the body processes cabotegravir and rilpivirine long-acting injections during pregnancy and after delivery — does that mean my HIV treatment itself would change, or is the main goal just to understand how the drugs behave at different stages of pregnancy?
2Since the trial is not yet recruiting, do you have a timeline for when it might open, and is there anything I should be doing now in terms of my current HIV treatment while I wait to see if I'd be a candidate?
3The study is measuring drug levels in the blood every four weeks throughout the second trimester, third trimester, and postpartum period — is that schedule of visits and blood draws realistic given my pregnancy care plan and other commitments?
4Because this trial has no listed phase and is primarily measuring how the drug is cleared from the body rather than testing effectiveness, what does that mean for what's already known — and not known — about the safety of these long-acting injections during pregnancy?
5If this trial turns out not to be the right fit for me, are there established standard-of-care HIV treatment options for pregnancy that we should be considering in the meantime?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Population PK: geometric mean clearance of CAB and RPV in second trimester, third trimester, and postpartum derived from a population PK model
Timeframe: Measured from study entry through six weeks postpartum
2
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
Timeframe: Measured from study entry through six weeks postpartum
Trial details
NCT IDNCT07637942
SponsorInternational Maternal Pediatric Adolescent AIDS Clinical Trials Group