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IMPAACT 2040 is a Phase I/II study of the pharmacokinetics (PK) and safety of long-acting injectable cabotegravir and rilpivirine (CAB LA + RPV LA) in people with virally suppressed HIV-1 during pregnancy and postpartum. The CREATE (Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy) study will enroll up to 45 pregnant people and their infants. The study includes two cohorts, based on dosing regimens:
- Cohort 1 will receive CAB LA + RPV LA every four weeks (Q4W dosing). Cohort 1 will open to accrual first.
- Cohort 2 will receive CAB LA + RPV LA every eight weeks (Q8W dosing). Recruitment into Cohort 2 will open if there are acceptable PK, safety, and virologic outcomes from the interim analysis with data from 10 evaluable Cohort 1 sentinel participants through six weeks' postpartum.
Each cohort will also be split into two groups (switch and continuation):
- The switch group will be on oral ART and then switched to intramuscular (IM) CAB LA + RPV LA, with an optional oral lead in of CAB + RPV.
- The continuation group will be on CAB LA + RPV LA and continue with IM dosing.
Participants and their infants will be followed for up to six weeks' postpartum in Cohort 1 and ten weeks postpartum in Cohort 2 to evaluate postpartum outcomes and neonatal safety of the regimen.
Site selection was initiated in September 2022. IMPAACT sites located in the US and South Africa were invited to participate. US sites were invited based on availability of the recruitment population (pregnant individuals continuing on CAB LA + RPV LA). Sites in South Africa were invited to participate based on the pharmaceutical partner's assessment of anticipated timelines for regulatory review and, if applicable, addition of CAB LA + RPV LA to national guidelines.