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Table 1 Inclusion/exclusion criteria

From: Azithromycin versus placebo for the treatment of HIV-associated chronic lung disease in children and adolescents (BREATHE trial): study protocol for a randomised controlled trial

Inclusion criteria

 • Perinatally acquired HIV (self-report of no sexual debut or blood transfusions, a history of orphanhood owing to maternal HIV disease and/or a history of sibling death due to HIV, and characteristic clinical features (i.e., stunting, history of recurrent minor infections in childhood and planar warts)

 • Aged 6–19 years

 • On first- or second-line ART for ≥ 6 months

 • Chronic lung disease (FEV1 z-score less than −1 and < 12% improvement with bronchodilator)

 • Firm home address accessible in Blantyre/Harare and intending to remain there for 18 months

 • Stable caregiver for participants aged < 18 years

 • HIV status disclosed to the child (for those aged > 12 years)

 • Informed consent to participate in the trial (for those aged < 18 years, consent from guardian and assent from participant; for those aged ≥ 18 years, consent from participant)

Exclusion criteria

 • Any condition that may prove fatal during the study period

 • Diagnosis of tuberculosis at enrolment

 • Acute respiratory tract infection during enrolment

 • Pregnancy and breastfeeding

 • History of prolonged QTc syndrome or current or planned therapy with drugs likely to cause cardiac dysrhythmias

 • History of cholestatic jaundice or hepatic dysfunction associated with previous use of azithromycin or known hypersensitivity to a macrolide or ketolide drug

 • Prolonged QTc interval (> 440 milliseconds in males; > 460 milliseconds in females)

 • Creatinine clearance < 30 ml/minute

 • ALT > 80 IU/L

 • Concomitant use of digoxin and/or fluconazole

 • Lack of understanding of the study procedure or uncooperative behaviour

  1. Abbreviations: ALT Alanine aminotransferase, ART Antiretroviral therapy, FEV 1 Forced expiratory volume in 1 second, HIV Human immunodeficiency virus