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Table 7 Severe who clinical stage 3 for the odyssey trial

From: 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

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
  1. 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