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Wits RHI

IMPAACT 2036 CRAYON Study

Infectious Diseases

Project Title

IMPAACT 2036 (CRAYON Study): Long-Acting HIV Treatment in Children

Overview

IMPAACT 2036 (CRAYON) is a Phase I/II clinical study evaluating the safety, tolerability, acceptability, and pharmacokinetics of oral and long-acting injectable Cabotegravir (CAB) and Rilpivirine (RPV) in children living with HIV-1. The study focuses on children aged 2 to under 12 years, who are already virologically suppressed on treatment, and explores both oral lead-in and direct-to-injectable treatment approaches.

Rationale

While daily oral antiretroviral therapy has transformed HIV care, maintaining long-term adherence in children can be challenging. Long-acting injectable treatments offer a promising alternative by reducing the need for daily medication. Cabotegravir and Rilpivirine long-acting formulations provide sustained drug exposure for extended periods, potentially improving adherence and treatment outcomes. However, limited data exists on their use in younger children, particularly across varying weight bands and developmental stages. This study addresses this gap by:

  • Evaluating age-appropriate dosing strategies
  • Assessing injectable treatment with and without an oral lead-in phase
  • Exploring caregiver and child experiences, including acceptability and preferences

The findings will support the safe and effective introduction of long-acting HIV treatment options for children, aligning with global efforts to improve paediatric HIV care.

Study Aim

The study aims to determine whether oral and long-acting injectable Cabotegravir and Rilpivirine are safe, effective, and acceptable for children, and to inform dosing strategies for wider use in paediatric HIV treatment.

Primary Objectives

  • Evaluate the pharmacokinetics of oral and injectable CAB + RPV
  • Assess the safety of both oral lead-in and long-acting injectable regimens through Week 24

Secondary Objectives

  • Assess longer-term safety and tolerability (up to 72 weeks)
  • Evaluate maintenance of viral suppression
  • Measure immune response outcomes
  • Assess treatment acceptability and caregiver perspectives
  • Monitor drug resistance patterns

Investigators

  • Prof Lee Fairlie – Principal Investigator
  • Dr Faeezah Patel
  • Dr Elizea Horne
  • Dr Mrinmayee Dhar
  • Dr Jeanne Coetzee
  • Tiffany Deborah Seef

Latest Update: March 2026

For more about IMPAACT 2036 CRAYON Study please email rhicomms@wrhi.ac.za

Click here to learn more about the IMPAACT 2036 CRAYON Study.

Project Brief

IMPAACT 2036 CRAYON Study