Table 1.
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