NCT02392182

Lung HIV Microbiome Project (Michigan Site)

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 59 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Healthy Participants
• Tobacco Use Disorder
• Human Microbiome

Interventions

Type	Name	Description
OTHER	Fiberoptic bronchoscopy	All subjects will undergo a research fiberoptic bronchoscopy under moderate conscious sedation. There is no randomization

Timeline

• Start date: 2009-10-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2015-03-18
• Last updated: 2016-09-16

Locations

1 site across 1 country: United States