drugset
drugset / Trial / NCT06336434

CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy

NCT06336434 ↗

Phase 1/2 Withdrawn National Institute of Allergy and Infectious Diseases (NIAID)
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

Drugs

EvaluationDrugModalityDoseRoute
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

Indications

HIV infectious disease pregnancy disorder puerperal disorder