BREATHE is a multi-site, individually randomised, double-blinded, placebo-controlled clinical trial. The trial aims to assess whether adjuvant treatment with azithromycin results in improvement in lung function in HIV-positive children with chronic lung disease. The main study outcome is Forced Expiratory Volume in one second z- score (FEV1z) after 12 months of initiation of the trial drug.
We are recruiting children and adolescents living with perinatally acquired with chronic lung disease aged 6-19 years in two hospitals in Harare, Zimbabwe and Blantyre, Malawi. Participants are randomised to either the control group or to a weekly weight-based dose of azithromycin for 12 months. The follow up period will be 18 months.
Cardiac sub-study will evaluate cardiac symptoms, echocardiographic findings and the effects of azithromycin treatment on right-sided cardiac function and pulmonary hypertension lead by Dr. Edith Majonga. Immunological sub-studies will focus on the effects of azithromycin on markers of systemic inflammation, microbial translocation and immune activation lead by Prof. Sarah Rowland-Jones, Oxford University. Microbiome sub-studies will investigate the diversity and composition of the respiratory and gut microbiome in HIV-positive children with chronic lung disease as well as determine the effect of azithromycin therapy on the microbiome composition, lead by Prof Mark Nicol, University of Capetown and collaborators at Arctic University of Norway.