BREATHE is a multi-site, individually randomised, double-blinded, placebo-controlled trial. Trial aims to assess whether adjuvant treatment with azithromycin results in improvement in lung function in HIV-positive children with chronic lung disease. 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 HIV-infected children with chronic lung disease aged 6-19 years in two hospitals in Harare, Zimbabwe and Blantyre, Malawi. Children 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.
Trial status: Enrolment has started in July 2016 and will continue until June 2018.
The study is funded by Medical Research Council of Norway
Trial registration number: NCT02426112 (registered with clinicaltrials.gov)
UiT The Arctic University of Norway