ODYSSEY clinical trial design: a randomised global study to evaluate the efficacy and safety of dolutegravir-based antiretroviral therapy in HIV-positive children, with nested pharmacokinetic sub-studies to evaluate pragmatic WHO-weight-band based dolutegravir dosing

Table 7 Severe who clinical stage 3 for the odyssey trial

Children (< 15 years of age)	Adolescents (≥15 years of age)
• Unexplained moderate malnutrition or wasting not adequately responding to standard therapy • Persistent oral candidiasis (after first 6–8 weeks of life) • Symptomatic lymphoid interstitial pneumonitis • Chronic HIV-associated lung disease including bronchiectasis	• Unexplained severe weight loss (> 10% of presumed or measured body weight) • Persistent oral candidiasis

Reference: World Health Organization. WHO case definitions of HIV for surveillance, and revised clinical staging and immunological classification of HIV related disease in adults and children. Geneva: World Health Organization; 2007

ISSN: 1471-2334