Phase 12 Study to Assess Safety and Effects of Cabotegravir in Newborns Exposed to HIV-1

What this Trial Is About

Researchers are evaluating the safety, tolerability, and how the body processes pharmacokinetics the drug cabotegravir in newborn babies exposed to HIV-1. This Phase 12 study focuses on neonates up to 10 days old who have been exposed to HIV-1 and whose mothers are on dolutegravir-based treatment. The study aims to gather important data on cabotegravir use in this vulnerable population to better understand its effects and safety. Participants are divided into four groups receiving different dosing regimens of cabotegravir. Some receive a single oral dose on Day 1, while others receive multiple oral doses with dosing frequency determined as the study progresses. Another group receives a single intramuscular IM dose of long-acting cabotegravir CAB LA on Day 1, and another group receives multiple IM doses. The doses and frequency for repeat dosing are adjusted based on emerging data from earlier groups. During the study, researchers will monitor drug levels in the blood at various time points up to several months, assess adverse events including injection site reactions, and evaluate safety through laboratory tests and physical exams. Mothers and infants will be followed closely for up to two months after the last dose. The main outcomes include measuring maximum drug concentrations and tracking any side effects or serious events. This comprehensive monitoring aims to ensure participant safety and gather critical information on cabotegravir use in neonates.

A Study to Investigate Cabotegravir for Neonates Exposed to HIV-1