Lung HIV Microbiome Project (Michigan Site)
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies, Smoking Cessation, Tobacco Consumers |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases, Other |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 4/21/2016 |
| Start Date: | October 2009 |
| End Date: | April 2015 |
Understanding the Lung Microbiome in HIV-Infected & HIV-Uninfected Individuals
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.
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.
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.
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.
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
We found this trial at
1
site
Click here to add this to my saved trials
