drugset / Trial / NCT06336434
CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a Phase I/II, multicenter, open-label, non-randomized study with four groups to characterize the pharmacokinetics and safety of Cabotegravir (CAB) and Rilpivirine (RPV) long-acting injectable (LA) during pregnancy and postpartum among people with HIV-1 viral suppression and their infants.
Timeline
- Start
- 2025-05-01
- Primary completion
- 2028-01-30
- Completion
- 2028-01-30
Outcome
Outcome not reported
Stopped (Business): “Due to shifting priorities and reduced funding, the IMPAACT Network is not able to continue efforts toward opening IMPAACT 2040.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cabotegravir | Small molecule | 400 mg | Intramuscular |
| Subject | Cabotegravir | Small molecule | 600 mg | Intramuscular |
| Subject | Rilpivirine | Small molecule | 600 mg | Intramuscular |
| Subject | Rilpivirine | Small molecule | 900 mg | Intramuscular |