Lung HIV Microbiome Project (Michigan Site)

Study Overview
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Brief Summary
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In its original phase, this cohort study recruited subjects who were either HIV-positive or HIV-negative healthy controls, to analyze the community structure of the lung microbiome. Original recruitment was planned to occur both at the University of Michigan Medical Center and clinics, and at VA Ann Arbor Healthcare System. Enrollment for the original cohort is completed, and all current activity of this project is occurring at VA Ann Arbor, where both Veteran subjects and non-Veteran subjects are eligible to participate. This study is currently recruiting only healthy HIV-negative subjects. Participation, described below, involves a research bronchoscopy procedure.

Detailed Description
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This is a non-interventional cohort study with single time point cross-sectional comparisons and longitudinal analyses, with the primary study aims of: evaluating how the immune deficiency associated with HIV infection influences the lung microbiome and lung function, and evaluating changes in lung microbiota over time. The study also aims to characterize the microbiome of the lower respiratory tract, determine the relationship between the lower respiratory Microbiome and the upper respiratory and gastrointestinal tract microbiomes, evaluate the influence of smoking on the microbiome compared with the influence of smoking on pulmonary function and respiratory systems, and to evaluate how Pneumocystis infection influences HIV-infected and HIV-uninfected individuals.

Official Title
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Understanding the Lung Microbiome in HIV-Infected & HIV-Uninfected Individuals

Conditions
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Healthy Participants, Tobacco Use Disorder, Human Microbiome

Intervention / Treatment
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* Other: Fiberoptic bronchoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Negative HIV testing (by ELISA) during initial study visit No signs of respiratory infection at enrollment, such as: fever; recent change in quantity of quality of sputum; chest pain; recent change in shortness of breath or exertional activity Willing and able to sign the informed consent document If female of child-bearing potential, negative pregnancy test during initial study visit Exclusion Criteria: Pregnancy Signs or symptoms of respiratory infection at enrollment Unwilling or unable to sign the informed consent document Unstable heart disease Other systemic disease and unlikely to survive at least 2 years Mental incompetence Participation in another interventional protocol within the last 6 weeks Use of antibiotics for a lung infection within the last 4 weeks Renal Failure (creatinine >3) Child's Class C Cirrhosis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| healthy volunteers<br>no intervention to be administered in this observational study, although all participants will undergo fiberoptic bronchoscopy. | Other: Fiberoptic bronchoscopy<br>* All subjects will undergo a research fiberoptic bronchoscopy under moderate conscious sedation. There is no randomization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung bacterial microbiome community structure | biological samples will be analyzed by culture-independent microbiological and bioinformatic techniques to determine the constituent members of the bacterial microbiome at each sampled site, to the level of operational taxonomic unit at 97% similarity to published sequences. | at time of bronchoscopy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung