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NCT04155684 · ClinicalTrials.gov registry record
Dysbiosis Impact on Lung Disease in HIV
A clinical trial, sponsored by University of Pittsburgh.
- Completed
- Registry status
- 50
- Enrollment target
NCT04155684: Completed study, sponsored by University of Pittsburgh.
NCT04155684 is a clinical trial that has completed, run by University of Pittsburgh. The registered enrollment target is 50 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04155684 has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- 50 participants
- Enrollment target
Study Summary
Despite the high burden of respiratory symptoms in the HIV+ population, causes of chronic obstructive pulmonary disease (COPD) in individuals with HIV are poorly understood. Microbial communities present in the lungs or gut could play an important role in COPD via their ability to stimulate inflammation and oxidative stress and by the interactions of microbial and host gene transcription. By exploring the impact of the structure and function of microbial communities on the host in HIV-associated COPD, this project could lead to discovery of novel therapeutics to treat and prevent COPD. Subjects will be 20 HIV+ individuals with COPD (FEV1/FVC \<0.70 and FEV1 and DLco\<80% predicted) and 20 HIV+ individuals with normal lung function (controls) and 10 HIV negative individuals recruited from our ongoing cohorts. Controls will be matched to the individuals with COPD based on age, gender, pack-years of smoking, ART use, HIV viral suppression, and history of illicit drug use. Bronchoscopy will be performed on all subjects. The investigator will uncover mechanisms that contribute to COPD in HIV+ individuals, which will lead to interventional therapies. For example, the investigators evaluate the impact of bacteria on lung epithelial cell gene expression and inflammation and test ability of anti-inflammatories to alter responses. Identification of other key pathways or microbes could also lead to testing of pro-biotics, post-biotics (bacterial metabolites), or therapy with bacteria genetically modified for desired function or metabolites.
Primary Outcome
Using 16S sequencing, we will compare unsorted bacteria from BAL to IgG- and IgM-bound and Ig-negative bacteria in HIV+ individuals with and without COPD.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2018-11-01 |
| Est. Completion | 2022-10-01 |
What the finished NCT04155684 record still lists
NCT04155684 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 50 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT04155684 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04155684 about?
NCT04155684 is a clinical study titled "Dysbiosis Impact on Lung Disease in HIV". Despite the high burden of respiratory symptoms in the HIV+ population, causes of chronic obstructive pulmonary disease (COPD) in individuals with HIV are poorly understood. Microbial communities present in the lungs or gut could play an important role in COPD via their ability to stimulate inflamma...
What is the current status of trial NCT04155684?
This trial is currently completed. The enrollment target is 50 participants. The study started on 2018-11-01. Estimated completion is 2022-10-01.
Who is sponsoring clinical trial NCT04155684?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
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