Bronchopulmonary Function in Response to Azithromycin Treatment for Chronic Lung Disease in HIV-infected Children
Status:
Completed
Trial end date:
2019-08-01
Target enrollment:
Participant gender:
Summary
Chronic pulmonary disease (CLD) is the most common manifestation of HIV/AIDS among children,
accounting for more than 50% of HIV-associated mortality. Recently, a novel form of CLD,
affecting more than 30% of African HIV-infected older children was described by Ferrand et al
in Zimbabwe, high-resolution CT scanning findings showed predominantly small airways disease
consistent with constrictive obliterative bronchiolitis (OB). . Azithromycin has
anti-inflammatory activity and treatment of CLD with this agent may lead to suppression of
generalized immune activation.
This specific aims of this project are to:
1. Primary objective: To investigate whether adjuvant treatment with azithromycin results
in improvement in lung function in HIV-infected children with chronic lung disease, who
are stable on antiretroviral therapy.
2. Secondary objectives:
1. To investigate the intervention effect on mortality, exacerbations of lung disease,
quality of life, morbidity.
2. To investigate adverse events related to azithromycin treatment
In total, 400 children aged 6-16 years, living with HIV and diagnosed with CLD will be
enrolled at Harare Children´s Hospital in Harare (Zimbabwe) and Queen Elizabeth Central
Hospital in Blantyre (Malawi). These will receive weekly treatment with azithromycin or
placebo during 12 months. Another 100 children (50 per site) living with HIV but with no CLD
will be enrolled as a comparison group for laboratory sub-studies.
Lung function will be assess using spirometry and the Forced expiratory volume in the first
minute (FEV1) will be the primary outcome. The mean change in FEV1 z-score levels will be
compared between trial arms after 12 months of initiation of azithromycin treatment.
Phase:
Phase 3
Details
Lead Sponsor:
London School of Hygiene and Tropical Medicine
Collaborators:
Biomedical Research and Training Institute Zimbabwe Biomedical Research and Training Institute, Zimbabwe Malawi-Liverpool-Wellcome Trust Clinical Research Programme University of Cape Town University of Oxford University of Tromso