Bronchopulmonary Function in Response to Azithromycin Treatment for Chronic Lung Disease in HIV-infected Children

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02426112
• Date of registration: 21/04/2015
• Prospective Registration: Yes
• Primary sponsor: London School of Hygiene and Tropical Medicine
• Public title: Bronchopulmonary Function in Response to Azithromycin Treatment for Chronic Lung Disease in HIV-infected Children BREATHE
• Scientific title: Bronchopulmonary Function in Response to Azithromycin Treatment for Chronic Lung Disease in HIV-infected Children
• Date of first enrolment: June 2016
• Target sample size: 347
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02426112
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Malawi, Zimbabwe

Contacts

• Name: Jon O Odland
• Affiliation: University of Tromso

• Name: Rashida Ferrand
• Affiliation: London School of Hygiene and Tropical Medicine

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Diagnosis of chronic lung disease (defined as FEV1 and/or FVC <80% predicted)

2. Age 6-19 years

3. Perinatally-acquired HIV infection the most likely source of transmission

4. On first or second-line ART for at least one year

5. HIV-1 viral load undetectable (as defined by each trial site)

6. A firm home address accessible for visiting and intending to remain there for 24
months

7. Willing to agree to participate in the study and to give samples of blood and sputum

8. HIV status disclosed to child for those aged older than 12 years

Exclusion Criteria:

1. Any condition (except HIV) that may prove fatal during the study period (e.g.
malignancy, end-stage HIV disease or other conditions deemed likely fatal by the trial
physician)

2. Diagnosis of active pulmonary TB

3. Infection with non-tuberculous mycobacteria (NTM)

4. Pregnant or breast-feeding

5. Condition likely to lead to lack of understanding of study procedures or to
uncooperative behaviour e.g. neurocognitive disease, developmental delay or
psychiatric illness

6. History of prolonged QTc syndrome or current or planned therapy with drugs likely to
cause cardiac dysrhythmias

7. Abnormal ECG findings

8. Acute respiratory tract infection during enrolment (patients will be eligible once
their acute infection is treated)

9. Creatinine clearance of <30mls/minute

10. ALT more than 2 times the upper limit of normal

11. No defined guardian/stable caregiver

12. No consent/assent from guardian/child



Age minimum: 6 Years
Age maximum: 19 Years
Gender: All

Health Condition(s) or Problem(s) studied

HIV Infection

Chronic Lung Disease

Intervention(s)

Drug: Placebo

Drug: Azithromycin

Primary Outcome(s)

Forced Expiratory Volume in one second z score (FEV1) [Time Frame: 12 months]

Secondary Outcome(s)

Number of gastroenteritis episodes [Time Frame: 12 months]

Mean change in weight-for-age z-score [Time Frame: 12 and 24 months]

Number of exacerbations [Time Frame: 12 and 24 months]

Quality of life scores [Time Frame: 12 and 24 months]

Number of mild, moderate and severe adverse events [Time Frame: 12 months]

Forced Expiratory Volume in one second z score (FEV1) [Time Frame: 24 months]

Number of blood stream infections due to Salmonella typhi and non-typhi [Time Frame: 12 months]

Number of Malaria episodes (Malawi only) [Time Frame: 12 months]

Time to death [Time Frame: 12 months]

Number of hospitalizations [Time Frame: 12 and 24 months]

Time to first acute exacerbation [Time Frame: 12 months]

Secondary ID(s)

QA698

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Tromso

University of Oxford

University of Cape Town

Biomedical Research and Training Institute, Zimbabwe

Malawi-Liverpool-Wellcome Trust Clinical Research Programme