Phase III Study of Oral and Injectable Cabotegravir and Rilpivirine in Children Ages 2 to Under 12 Years With HIV-1 Evaluating Safety, Tolerability, and Drug Levels in Virologically Suppressed Children

What this Trial Is About

Researchers are studying the safety, tolerability, acceptability, and how the body processes pharmacokinetics oral and long-acting injectable forms of Cabotegravir and Rilpivirine in children living with HIV-1 who are virologically suppressed and aged between two to less than 12 years. This Phase III, multicenter, open-label study aims to propose appropriate weight-based dosing and to evaluate the injectable regimen with or without an oral lead-in period in these children. Participants are grouped into three cohorts Cohort 1 receives daily oral Cabotegravir and Rilpivirine tablets for about four weeks followed by intramuscular injections every four or eight weeks Cohort 2A also starts with daily oral doses followed by injections Cohort 2B receives only the injections on the same schedules. If participants cannot access the injections after the study, they may join a Study Safety Extension period to continue safety monitoring. During the study, children will have multiple assessments including blood tests to measure drug levels and monitor immune cell counts, safety evaluations for side effects, and questionnaires for children and caregivers about side effects and injection site reactions. The study tracks safety events and HIV viral load at key timepoints up to 72 weeks. Caregivers may also participate by completing behavioral surveys. The total participation may include up to the extension period for ongoing safety monitoring.

Study of Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in Virologically Suppressed Children Living With HIV-1, Two to Less Than 12 Years of Age