According to UNAIDS Global report, 3.4 million children under 15 years are infected with HIV. Most of them live in Sub-Saharan Africa, where HIV remains the major health related problem. The introduction of antiretroviral therapy (ART) significantly improved overall survival, yet led to increased incidence of chronic HIV-associated complications.
Recent data demonstrate that up to 30% of HIV-positive children and adolescents present with chronic respiratory symptoms or severe chest radiologic abnormalities. The burden of these chronic pulmonary complications is associated with chronic inflammation, immune activation and oxidative stress that persist despite ART. At present, no guidelines for diagnosis and treatment of chronic lung disease in HIV-positive children are available. Prescription of adjuvant antibiotics as a possible intervention strategy may delay progression of airway disease and reduce mortality. Several randomized control trials demonstrate that long term azithromycin treatment significantly improves respiratory function and reduces the number of pulmonary exacerbations in patients with airway diseases
The main objective of our trial is 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 ART.
Lung function will be assessed using spirometry with Forced Expiratory Volume in the first second being the primary outcome. We will also evaluate acute exacerbations, number of hospitalizations and adverse events related to azithromycin treatment.