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. 2017 Dec 28;18:622. doi: 10.1186/s13063-017-2344-2

Table 1.

Inclusion/exclusion criteria

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

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