IMPAACT 2036 CRAYON Study
The IMPAACT 2036 CRAYON Study is a Phase I/II clinical trial focused on evaluating the safety, tolerability, acceptability, and pharmacokinetics of oral and long-acting injectable formulations of cabotegravir (CAB) and rilpivirine (RPV) in virologically suppressed children living with HIV-1, aged 2 to less than 12 years. This innovative study seeks to develop a weight-based dosing regimen for these treatments, aiming to provide a practical alternative for pediatric HIV-1 management.
Rationale
IMPAACT 2036 addresses the need for alternative treatment options for young children living with HIV-1, providing a structured approach to assess both oral CAB + RPV and their long-acting injectable counterparts (CAB LA + RPV LA). These injectables offer prolonged drug exposure, which could simplify medication schedules for young patients. Given the lack of significant therapeutic benefit in children under two years, per regulatory guidance from the European Medicines Authority (EMA) and U.S. Food and Drug Administration (FDA), the study focuses on children between 2 and 12 years of age who meet specific weight criteria (≥10 kg and <40 kg). This trial builds on the success of adult studies (FLAIR, ATLAS) by incorporating similar lead-in and direct-to-injection approaches to ensure optimal dosing and safety.
Objectives
The CRAYON Study aims to:
- Establish a weight-band-based dosing protocol for both oral and long-acting injectable CAB + RPV in children aged 2–12, with the goal of enabling safe and effective pediatric treatment options.
- Assess the pharmacokinetics, safety, and tolerability of CAB LA + RPV LA with and without a 4-week oral lead-in phase, allowing for individualized treatment approaches.
- Collect data on the acceptability and feasibility of CAB LA + RPV LA administration in young children, incorporating caregiver and participant input to guide real-world application.
Cohort Design and Safety
The study includes two cohorts. Cohort 1 utilizes a 4-week oral lead-in phase before transitioning to injectable treatment, enabling early detection of any potential adverse reactions. Cohort 2 offers an optional lead-in period, providing participants, caregivers, and clinicians with flexibility in treatment decisions.
This study promises to advance pediatric HIV treatment, making it easier and more adaptable for children living with HIV-1 and their families.
Investigators
- Prof Lee Fairlie, Principal Investigator
- Dr Muneerah Khan
- Dr Faeezah Patel
- Dr Elizea Horne
- Dr Mrinmayee Dhar
- Dr Robert Kieser
- Dr Pemphero Chesela
- Dr Jeanne Coetzee
Latest Update
June 2024
For more about IMPAACT 2036 CRAYON Study please email rhicomms@wrhi.ac.za
Click here to learn more about the IMPAACT 2036 CRAYON Study.
