Umlazi

Researchers are evaluating the safety, tolerability, acceptability, and pharmacokinetics of oral and long-acting injectable Cabotegravir (CAB) and Rilpivirine (RPV) in children aged two to less than twelve years living with HIV-1 who are virologically suppressed. This Phase I/II, multicenter, open-label, non-comparative study aims to propose appropriate weight-band dosing and assess the injectable regimen with and without an oral lead-in period in this population. The study also includes a safety extension period to monitor for toxicities if participants cannot access the injections after the study ends. Participants will first receive daily oral tablets of CAB and RPV, followed by long-acting injectable CAB and RPV. The study involves an oral lead-in phase followed by an injection phase for eligible participants. If injections are not accessible post-study, participants may enter a safety extension period for ongoing monitoring. The treatments are monitored through various pharmacokinetic measures at multiple time points, including weeks 2, 5, 8, 12, and 24. Throughout the study, children will undergo laboratory tests, electrocardiograms, and safety assessments to evaluate drug levels, side effects, and tolerability. Researchers will monitor for adverse events, serious adverse events, and reasons for discontinuation during both the oral and injectable phases. Caregivers may also participate in behavioral surveys or interviews. The total participation duration includes the initial treatment phases and a possible extended safety monitoring period.