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Wits RHI

M1439-066

Infectious Diseases
Vaccine Preventable Diseases

Project Title

KK-1439-066: A Phase 2 Clinical Study of Doravirine-Based Treatment in Children Living with HIV-1

Overview

This Phase 2 clinical study evaluates the pharmacokinetics (PK), safety, tolerability, and efficacy of Doravirine (DOR), administered either in combination with two nucleoside reverse transcriptase inhibitors (NRTIs) or as a fixed-dose combination (DOR/3TC/TDF), in children living with HIV-1. The study focuses on paediatric participants aged 4 weeks to under 12 years, weighing less than 45 kg, and includes both treatment-naïve and virologically suppressed children.

Rationale

Achieving and maintaining viral suppression is the primary goal of antiretroviral therapy (ART) in both adults and children living with HIV. In paediatric populations, this is especially critical, as untreated HIV progresses more rapidly, leading to higher risks of severe illness and mortality. Early and sustained viral suppression:

  • Preserves and restores immune function
  • Reduces the risk of drug resistance
  • Improves survival outcomes
  • Supports healthy neurocognitive development

While combination ART (cART) has significantly improved outcomes in children, there remains a need for well-tolerated, effective, and easy-to-administer treatment options, particularly those suitable for young children. This study aims to address this gap by evaluating age-appropriate formulations of Doravirine.

Study Aim

The study aims to determine whether Doravirine-based regimens are safe, effective, and appropriate for use in children, supporting improved HIV treatment options for this vulnerable population.

Primary Objectives

  • Evaluate the pharmacokinetics of Doravirine in children
  • Assess the safety and tolerability of Doravirine-based regimens through Week 24

Secondary Objectives

  • Assess longer-term safety and tolerability (up to 96 weeks)
  • Evaluate antiretroviral efficacy, including viral suppression rates
  • Measure immune response (CD4+ T-cell changes)
  • Monitor drug resistance patterns
  • Assess treatment adherence
  • Evaluate acceptability and palatability of paediatric formulations

Investigators

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

Latest Update: March 2026

For more about M1439-066 study please email rhicomms@wrhi.ac.za

Project Brief

MK 066