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Clinical trialNCT04070248UnknownObservational

Determining Bacterial Communities in the Lungs of HIV-infected Individuals With COPD in Uganda.

SponsorMakerere UniversityEnrollment200COPDHIV/AIDS
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Research question Is there any association between altered lung bacterial communities and HIV-associated Chronic Obstructive Pulmonary Disease (COPD)? Rationale Sub-Saharan Africa has experienced dramatic increases in COPD related-morbidity and mortality. Longitudinal studies have shown that people living with HIV develop worsening airflow obstruction with a prevalence higher than that of the general population (i.e 3.4 to 21% compared to 0.4 to 12.2%). It is still unknown why HIV-infected individuals develop COPD at a prevalence higher than their HIV-negative counterparts. It's been hypothesized that a change in the lung bacterial communities in the setting of HIV drives inflammation leading to lung damage. There is a need to explore the dynamics of lung bacterial communities and elucidate mechanisms responsible for irreversible lung damage that may follow lung disturbances in bacterial richness and diversity. In addition, understanding the bacterial communities of the lung in normal subjects is an essential step in providing negative controls to interpret lung microbe in disease states for-example COPD. Insights from this research will inform efforts to design optimal screening and treatment strategies for COPD in the HIV-infected population in sub Saharan Africa. Methods A cross sectional study will be conducted in which lung bacterial communities in 63 HIV infected participants ≥ 35 years with and without COPD will be compared with 63 HIV negative participants with and without COPD. Participants will be recruited from COPD/HIV and LINK Nakaseke cohorts, which were population based studies conducted in the same study setting. Sputum samples will be collected using sputum DNA collection, preservation and isolation Kits. Extracted bacterial DNA will be sequenced and used to determine all bacterial species in the processed samples using available online metagenomics databases. Analysis plan A histogram will be used to display the frequencies of the identified bacterial species in the processed samples. Bacterial richness and diversity of samples in the 4 groups will be compared to determine any differences.

Investigators

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Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Uganda
  • Makerere University Lung Institute

    Kampala, Uganda

    Alex Kayongo, MBChB,MScBernard S Bagaya, BBLT,MSc,PhDBruce Kirenga, MBChB,MmedDaudi Jjingo, PhDDavid P Kateete, BVM,MSc,PhDMoses L Joloba, MD,PhDRobert Kalyesubula, MBChB,MmedTrishul Siddharthan, MDWilliam Checkley, MD,PhD
    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study — it may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
11 Jan 2019
Primary completion
29 Feb 2020
Completion
28 Feb 2021
Last update posted
30 Aug 2019
Registered enrollment
200
Registry id
NCT04070248

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.