Chronic Lung DiseasePhase 3BREATHENCT02426112
Bronchopulmonary Function in Response to Azithromycin Treatment for Chronic Lung Disease in HIV-infected Children
A Phase 3 study testing Azithromycin in people with Chronic Lung Disease and HIV Infection, run by London School of Hygiene and Tropical Medicine at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 19 years
- Conditions the study is for
- Chronic Lung Disease, HIV Infection
- What is being tested?
- Azithromycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 347 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2016to Aug 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of chronic lung disease (defined as FEV1 and/or FVC <80% predicted)
- Age 6-19 years
- Perinatally-acquired HIV infection the most likely source of transmission
- On first or second-line ART for at least one year
- HIV-1 viral load undetectable (as defined by each trial site)
- A firm home address accessible for visiting and intending to remain there for 24 months
- Willing to agree to participate in the study and to give samples of blood and sputum
- HIV status disclosed to child for those aged older than 12 years
Who cannot join
- 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)
- Diagnosis of active pulmonary TB
- Infection with non-tuberculous mycobacteria (NTM)
- Pregnant or breast-feeding
- Condition likely to lead to lack of understanding of study procedures or to uncooperative behaviour e.g. neurocognitive disease, developmental delay or psychiatric illness
- History of prolonged QTc syndrome or current or planned therapy with drugs likely to cause cardiac dysrhythmias
Show all 12Show fewer
- Abnormal ECG findings
- Acute respiratory tract infection during enrolment (patients will be eligible once their acute infection is treated)
- Creatinine clearance of <30mls/minute
- ALT more than 2 times the upper limit of normal
- No defined guardian/stable caregiver
- No consent/assent from guardian/child
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Malawi1 site
Malawi-Liverpool-Wellcome Trust Clinical Research Programme
Blantyre, 30096
About this study
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:
Read more
- 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.
- Secondary objectives:
- To investigate the intervention effect on mortality, exacerbations of lung disease, quality of life, morbidity.
- 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.
Read the detailed description
Clinical Phase: III
Trial Design: Multi-site, individually randomised, double-blinded, placebo-controlled trial of weekly azithromycin for 12 months
Trial Participants: Children aged 6-16 years living with HIV and with diagnosis of chronic lung disease. Another 200 children living with HIV but with no chronic lung disease in a comparison arm.
Planned Sample Size: 400 cases and 100 in the comparison arm
Treatment duration: 12 months
Follow up duration: 18 months
Planned Trial Period: June 2016-September 2019
Objectives:
- Primary trial outcome: 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.
- Secondary trial outcomes:
.To investigate the intervention effect on mortality,exacerbations of lung disease, quality of life and morbidity..
.To investigate adverse events related to azithromycin treatment. .-Laboratory sub-studies .To determine the effect of azithromycin therapy on antimicrobial resistance in bacteria colonizing the respiratory tract.
.To investigate the diversity and composition of the respiratory microbiome in HIV-infected children with CLD.
.To investigate the diversity and composition of the gut microbiome in HIV-infected children with CLD.
.To investigate the effect of azithromycin on biomarkers of systemic inflammation in HIV-infected children with CLD.
.-Cardiac sub-study: .Describe the cardiac symptoms and echocardiograph findings of HIV-infected children with chronic lung disease.
.To investigate whether adjuvant treatment with azithromycin results in improvement in right-sided cardiac function and/or pulmonary hypertension in HIV-infected children with chronic lung disease.
Investigational Medicinal Product(s): Azithromycin and placebo.
Formulation:Tablets 250 mg
Dose: According to weight bands (30 mg/kg/week):
- 10-20 kg: 250 mg
- 20-29 kg: 500 mg
- 30-39 kg: 750 mg
- 40-49 kg: 1250 mg
Route of Administration:Oral
- Conditions
- Chronic Lung Disease, HIV Infection
- Being tested
- Azithromycin, Placebo
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzithromycinDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Azithomycin | Active comparator | Azithromycin tablets 250 mg, 30mg/kg/week by mouth, once a week for 12 months.
* 10-20 kg: 250 mg
* 20-29 kg: 500 mg
* 30-39 kg: 750 mg
* 40-49 kg: 1250 mg Receives: Drug: Azithromycin |
| Placebo | Placebo comparator | Placebo tablets 250 mg, 30 mg/kg/week by mouth, once a week for 12 months.
* 10-20 kg: 250 mg
* 20-29 kg: 500 mg
* 30-39 kg: 750 mg
* 40-49 kg: 1250 mg Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Expiratory Volume in one second z score (FEV1)
Change in FEV1after 12 months of initiation of therapy with azithromycin
Measured: 12 months
Secondary outcomes (11)
Forced Expiratory Volume in one second z score (FEV1)
Mean change in FEV1 24 months after treatment initiation with azithromycin
Measured: 24 months
Time to death
Time to death 12 months after treatment initiation with azithromycin
Measured: 12 months
Time to first acute exacerbation
Measured: 12 months
Number of hospitalizations
Measured: 12 and 24 months
Number of exacerbations
Measured: 12 and 24 months
Quality of life scores
Measured: 12 and 24 months
Mean change in weight-for-age z-score
Measured: 12 and 24 months
Number of mild, moderate and severe adverse events
Measured: 12 months
Number of Malaria episodes (Malawi only)
Measured: 12 months
Number of blood stream infections due to Salmonella typhi and non-typhi
Measured: 12 months
Number of gastroenteritis episodes
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2015 (estimated)
- Study startJun 2016
- Primary completionSep 2018
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Chronic Lung DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 347 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Biomedical Research and Training Institute, Zimbabwe, Malawi-Liverpool-Wellcome Trust Clinical Research Programme, University of Tromso, University of Cape Town, University of Oxford
- Responsible party
- Sponsor
- Investigators
- Rashida Ferrand, Principal investigator, London School of Hygiene and Tropical MedicineJon O Odland, Principal investigator, University of Tromso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02426112
- Sponsor's protocol ID
- QA698
- Acronym
- BREATHE
- Status last verified
- Oct 2019
- First submitted
- 21 Apr 2015
- Last updated
- 9 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Mushunje PK, Sovershaeva E, Olwagen CP, Madhi S, Odland JO, Ferrand RA, Nicol MP, Abotsi RE, Dube FS. Weekly azithromycin for 48 weeks impacts nasopharyngeal microbial prevalence and Streptococcus pneumoniae serotypes in children with HIV-associated chronic lung disease. Sci Rep. 2025 Nov 7;15(1):39175. doi: 10.1038/s41598-025-23693-6.
PubMed 41203736Madanhire T, McHugh G, Simms V, Ngwira L, Gonzalez-Martinez C, Semphere R, Moyo B, Calderwood C, Nicol M, Bandason T, Odland JO, Rehman AM, Ferrand RA. Longitudinal lung function trajectories in response to azithromycin therapy for chronic lung disease in children with HIV infection: a secondary analysis of the BREATHE trial. BMC Pulm Med. 2024 Jul 12;24(1):339. doi: 10.1186/s12890-024-03155-x.
PubMed 38997676Mushunje PK, Dube FS, Olwagen C, Madhi S, Odland JO, Ferrand RA, Nicol MP, Abotsi RE; BREATHE study team. Characterization of bacterial and viral pathogens in the respiratory tract of children with HIV-associated chronic lung disease: a case-control study. BMC Infect Dis. 2024 Jun 26;24(1):637. doi: 10.1186/s12879-024-09540-5.
PubMed 38926682Ngwira LG, Maheswaran H, Verstraete J, Petrou S, Niessen L, Smith SC. Psychometric performance of the Chichewa versions of the EQ-5D-Y-3L and EQ-5D-Y-5L among healthy and sick children and adolescents in Malawi. J Patient Rep Outcomes. 2023 Mar 9;7(1):22. doi: 10.1186/s41687-023-00560-4.
PubMed 36892714Rehman AM, Simms V, McHugh G, Mujuru H, Ngwira LG, Semphere R, Moyo B, Bandason T, Odland JO, Ferrand RA. Adherence to additional medication for management of HIV-associated comorbidities among older children and adolescents taking antiretroviral therapy. PLoS One. 2022 Jun 15;17(6):e0269229. doi: 10.1371/journal.pone.0269229. eCollection 2022.
PubMed 35704559Jackson C, Rehman AM, McHugh G, Gonzalez-Martinez C, Ngwira LG, Bandason T, Mujuru H, Odland JO, Corbett EL, Ferrand RA, Simms V. Risk factors for sustained virological non-suppression among children and adolescents living with HIV in Zimbabwe and Malawi: a secondary data analysis. BMC Pediatr. 2022 Jun 11;22(1):340. doi: 10.1186/s12887-022-03400-4.
PubMed 35690762Ferrand RA, McHugh G, Rehman AM, Mujuru H, Simms V, Majonga ED, Nicol MP, Flaegstad T, Gutteberg TJ, Gonzalez-Martinez C, Corbett EL, Rowland-Jones SL, Kranzer K, Weiss HA, Odland JO; BREATHE Trial Group. Effect of Once-Weekly Azithromycin vs Placebo in Children With HIV-Associated Chronic Lung Disease: The BREATHE Randomized Clinical Trial. JAMA Netw Open. 2020 Dec 1;3(12):e2028484. doi: 10.1001/jamanetworkopen.2020.28484.
PubMed 33331916Rehman AM, Ferrand R, Allen E, Simms V, McHugh G, Weiss HA. Exclusion of enrolled participants in randomised controlled trials: what to do with ineligible participants? BMJ Open. 2020 Dec 2;10(12):e039546. doi: 10.1136/bmjopen-2020-039546.
PubMed 33268410McHugh G, Rehman AM, Simms V, Gonzalez-Martinez C, Bandason T, Dauya E, Moyo B, Mujuru H, Rylance J, Sovershaeva E, Weiss HA, Kranzer K, Odland J, Ferrand RA; BREATHE Clinical Trial Team. Chronic lung disease in children and adolescents with HIV: a case-control study. Trop Med Int Health. 2020 May;25(5):590-599. doi: 10.1111/tmi.13375. Epub 2020 Feb 10.
PubMed 31989731Gonzalez-Martinez C, Kranzer K, McHugh G, Corbett EL, Mujuru H, Nicol MP, Rowland-Jones S, Rehman AM, Gutteberg TJ, Flaegstad T, Odland JO, Ferrand RA; BREATHE study team. Azithromycin versus placebo for the treatment of HIV-associated chronic lung disease in children and adolescents (BREATHE trial): study protocol for a randomised controlled trial. Trials. 2017 Dec 28;18(1):622. doi: 10.1186/s13063-017-2344-2.
PubMed 29282143
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bronchopulmonary Function in Response to Azithromycin Treatment for Chronic Lung Disease in HIV-infected Children
- ClinicalTrials.gov ID
- NCT02426112
- Acronym / sponsor ID
- BREATHE / QA698
- Conditions
- Chronic Lung Disease, HIV Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 347 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Biomedical Research and Training Institute, Zimbabwe, Malawi-Liverpool-Wellcome Trust Clinical Research Programme, University of Tromso, University of Cape Town, University of Oxford
- Study start
- Jun 2016
- Primary completion
- Sep 2018 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 24 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- Secondary objectives:
- To investigate the intervention effect on mortality, exacerbations of lung disease, quality of life, morbidity.
- 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.
Detailed description
Clinical Phase: III
Trial Design: Multi-site, individually randomised, double-blinded, placebo-controlled trial of weekly azithromycin for 12 months
Trial Participants: Children aged 6-16 years living with HIV and with diagnosis of chronic lung disease. Another 200 children living with HIV but with no chronic lung disease in a comparison arm.
Planned Sample Size: 400 cases and 100 in the comparison arm
Treatment duration: 12 months
Follow up duration: 18 months
Planned Trial Period: June 2016-September 2019
Objectives:
- Primary trial outcome: 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.
- Secondary trial outcomes:
.To investigate the intervention effect on mortality,exacerbations of lung disease, quality of life and morbidity..
.To investigate adverse events related to azithromycin treatment. .-Laboratory sub-studies .To determine the effect of azithromycin therapy on antimicrobial resistance in bacteria colonizing the respiratory tract.
.To investigate the diversity and composition of the respiratory microbiome in HIV-infected children with CLD.
.To investigate the diversity and composition of the gut microbiome in HIV-infected children with CLD.
.To investigate the effect of azithromycin on biomarkers of systemic inflammation in HIV-infected children with CLD.
.-Cardiac sub-study: .Describe the cardiac symptoms and echocardiograph findings of HIV-infected children with chronic lung disease.
.To investigate whether adjuvant treatment with azithromycin results in improvement in right-sided cardiac function and/or pulmonary hypertension in HIV-infected children with chronic lung disease.
Investigational Medicinal Product(s): Azithromycin and placebo.
Formulation:Tablets 250 mg
Dose: According to weight bands (30 mg/kg/week):
- 10-20 kg: 250 mg
- 20-29 kg: 500 mg
- 30-39 kg: 750 mg
- 40-49 kg: 1250 mg
Route of Administration:Oral
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Azithomycin | Active comparator | Drug: AzithromycinAzithromycin tablets 250 mg, 30mg/kg/week by mouth, once a week for 12 months. * 10-20 kg: 250 mg * 20-29 kg: 500 mg * 30-39 kg: 750 mg * 40-49 kg: 1250 mg |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo tablets 250 mg, 30 mg/kg/week by mouth, once a week for 12 months. * 10-20 kg: 250 mg * 20-29 kg: 500 mg * 30-39 kg: 750 mg * 40-49 kg: 1250 mg |
Who may qualify
- Ages
- 6 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Diagnosis of chronic lung disease (defined as FEV1 and/or FVC <80% predicted)
- Age 6-19 years
- Perinatally-acquired HIV infection the most likely source of transmission
- On first or second-line ART for at least one year
- HIV-1 viral load undetectable (as defined by each trial site)
Key exclusion criteria (12 listed)
- 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)
- Diagnosis of active pulmonary TB
- Infection with non-tuberculous mycobacteria (NTM)
- Pregnant or breast-feeding
- Condition likely to lead to lack of understanding of study procedures or to uncooperative behaviour e.g. neurocognitive disease, developmental delay or psychiatric illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Azithromycin | Drug | Azithomycin |
| Placebo | Drug | Placebo |
Primary outcome
Forced Expiratory Volume in one second z score (FEV1)
Time frame: 12 months
Change in FEV1after 12 months of initiation of therapy with azithromycin
11 secondary outcomes
Forced Expiratory Volume in one second z score (FEV1)
Time frame: 24 months
Time to death
Time frame: 12 months
Time to first acute exacerbation
Time frame: 12 months
Number of hospitalizations
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
Mean change in weight-for-age z-score
Time frame: 12 and 24 months
Number of mild, moderate and severe adverse events
Time frame: 12 months
Number of Malaria episodes (Malawi only)
Time frame: 12 months
Number of blood stream infections due to Salmonella typhi and non-typhi
Time frame: 12 months
Number of gastroenteritis episodes
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2019.
- Derived from this study: PubMed 41203736Mushunje PK, Sovershaeva E, Olwagen CP, Madhi S, Odland JO, Ferrand RA, Nicol MP, Abotsi RE, Dube FS. Weekly azithromycin for 48 weeks impacts nasopharyngeal microbial prevalence and Streptococcus pneumoniae serotypes in children with HIV-associated chronic lung disease. Sci Rep. 2025 Nov 7;15(1):39175. doi: 10.1038/s41598-025-23693-6.
- Derived from this study: PubMed 38997676Madanhire T, McHugh G, Simms V, Ngwira L, Gonzalez-Martinez C, Semphere R, Moyo B, Calderwood C, Nicol M, Bandason T, Odland JO, Rehman AM, Ferrand RA. Longitudinal lung function trajectories in response to azithromycin therapy for chronic lung disease in children with HIV infection: a secondary analysis of the BREATHE trial. BMC Pulm Med. 2024 Jul 12;24(1):339. doi: 10.1186/s12890-024-03155-x.
- Derived from this study: PubMed 38926682Mushunje PK, Dube FS, Olwagen C, Madhi S, Odland JO, Ferrand RA, Nicol MP, Abotsi RE; BREATHE study team. Characterization of bacterial and viral pathogens in the respiratory tract of children with HIV-associated chronic lung disease: a case-control study. BMC Infect Dis. 2024 Jun 26;24(1):637. doi: 10.1186/s12879-024-09540-5.
- Derived from this study: PubMed 36892714Ngwira LG, Maheswaran H, Verstraete J, Petrou S, Niessen L, Smith SC. Psychometric performance of the Chichewa versions of the EQ-5D-Y-3L and EQ-5D-Y-5L among healthy and sick children and adolescents in Malawi. J Patient Rep Outcomes. 2023 Mar 9;7(1):22. doi: 10.1186/s41687-023-00560-4.
- Derived from this study: PubMed 35704559Rehman AM, Simms V, McHugh G, Mujuru H, Ngwira LG, Semphere R, Moyo B, Bandason T, Odland JO, Ferrand RA. Adherence to additional medication for management of HIV-associated comorbidities among older children and adolescents taking antiretroviral therapy. PLoS One. 2022 Jun 15;17(6):e0269229. doi: 10.1371/journal.pone.0269229. eCollection 2022.
- Derived from this study: PubMed 35690762Jackson C, Rehman AM, McHugh G, Gonzalez-Martinez C, Ngwira LG, Bandason T, Mujuru H, Odland JO, Corbett EL, Ferrand RA, Simms V. Risk factors for sustained virological non-suppression among children and adolescents living with HIV in Zimbabwe and Malawi: a secondary data analysis. BMC Pediatr. 2022 Jun 11;22(1):340. doi: 10.1186/s12887-022-03400-4.
- Derived from this study: PubMed 33331916Ferrand RA, McHugh G, Rehman AM, Mujuru H, Simms V, Majonga ED, Nicol MP, Flaegstad T, Gutteberg TJ, Gonzalez-Martinez C, Corbett EL, Rowland-Jones SL, Kranzer K, Weiss HA, Odland JO; BREATHE Trial Group. Effect of Once-Weekly Azithromycin vs Placebo in Children With HIV-Associated Chronic Lung Disease: The BREATHE Randomized Clinical Trial. JAMA Netw Open. 2020 Dec 1;3(12):e2028484. doi: 10.1001/jamanetworkopen.2020.28484.
- Derived from this study: PubMed 33268410Rehman AM, Ferrand R, Allen E, Simms V, McHugh G, Weiss HA. Exclusion of enrolled participants in randomised controlled trials: what to do with ineligible participants? BMJ Open. 2020 Dec 2;10(12):e039546. doi: 10.1136/bmjopen-2020-039546.
- Derived from this study: PubMed 31989731McHugh G, Rehman AM, Simms V, Gonzalez-Martinez C, Bandason T, Dauya E, Moyo B, Mujuru H, Rylance J, Sovershaeva E, Weiss HA, Kranzer K, Odland J, Ferrand RA; BREATHE Clinical Trial Team. Chronic lung disease in children and adolescents with HIV: a case-control study. Trop Med Int Health. 2020 May;25(5):590-599. doi: 10.1111/tmi.13375. Epub 2020 Feb 10.
- Derived from this study: PubMed 29282143Gonzalez-Martinez C, Kranzer K, McHugh G, Corbett EL, Mujuru H, Nicol MP, Rowland-Jones S, Rehman AM, Gutteberg TJ, Flaegstad T, Odland JO, Ferrand RA; BREATHE study team. Azithromycin versus placebo for the treatment of HIV-associated chronic lung disease in children and adolescents (BREATHE trial): study protocol for a randomised controlled trial. Trials. 2017 Dec 28;18(1):622. doi: 10.1186/s13063-017-2344-2.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rashida Ferrand principal investigator
London School of Hygiene and Tropical Medicine
Jon O Odland principal investigator
University of Tromso
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Azithromycin in people with Chronic Lung Disease and HIV Infection, run by London School of Hygiene and Tropical Medicine at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Malawi, Zimbabwe. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced Expiratory Volume in one second z score (FEV1) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02426112, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2019.