Determine the Prevalence and Severity of Asthma in HIV (Human Immunodeficiency Virus) Infected Patients



Status:Completed
Conditions:Asthma, HIV / AIDS, HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:10/5/2017
Start Date:December 2014
End Date:July 2017

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HIV and Asthma in the Post-ART (Antiretroviral Therapy) Era

The purpose of this study is to determine the prevalence and severity of asthma in patients
with HIV. To determine the immunological phenotype of HIV-infected patients with asthma.

Prospectively clinically phenotype and the prevalence of asthma in HIV infected patients in
the Duke ID Clinic

- HIV infected asthmatic subjects meeting clinical definitions for asthma compared to HIV
uninfected asthma subjects identified at the DAAAC and HIV infected non-asthmatic
subjects.

- Prospective immunological phenotyping - HIV-infected asthma subjects prospectively
identified and clinically phenotyped compared to HIV-uninfected asthma subjects
identified at the DAAAC and HIV infected non-asthma subjects.

Regarding the sampling method of probability sample: All samples for HIV infected asthmatic
patients, HIV uninfected asthmatic patients and HIV infected non-asthmatics patients will be
analyzed.

Retrospectively determine overall asthma prevalence and severity among HIV-infected patients.
Retrospective immunological phenotyping (circulating cytokines) of HIV-infected patients
utilizing available specimens in the Duke HIV Specimen Biorepository

- HIV-infected asthmatic subjects meeting asthma definition compared to overall asthma
prevalence in U.S. population

- HIV-infected asthma subjects meeting asthma definitions compared to matched HIV-infected
non-asthma subjects

Inclusion Criteria:

- HIV infected asthmatic and non-asthmatic adults ≥18 years

- HIV uninfected asthma adults ≥18 years

- Females of childbearing potential have to be using medically acceptable contraceptive
method for the duration of the study.

- Willing and able to give informed consent and adhere to visit/protocol schedules.

- Negative pregnancy test in women of childbearing potential

- For asthma patients: known or possible diagnosis of asthma for at least one year

Exclusion Criteria:

- Antibiotic administration for upper respiratory infection within the prior 30 days

- Greater than 10 pack a year smoking history

- No prior use of steroids (systemic) within the past 3 months

- Underlying illnesses that may result in altered lung function

- Students or employees who are under direct supervision of any Project or Core
PI/Director.

- Pregnant or nursing mothers.

- Poorly controlled concomitant conditions as determined by the investigator.

- Subjects who have had an elective procedure (for example, colonoscopy, cystoscopy,
etc.) within less than 2 weeks of the procedure date cannot be enrolled in the HIV
Asthma study

- Subjects must delay enrollment by 2 weeks into the HIV Asthma study if they have
received a single dose of systemic steroids
We found this trial at
1
site
Durham, North Carolina 27704
Principal Investigator: Loretta Que, M.D.
?
mi
from
Durham, NC
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