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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

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

Conditions
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HIV, Asthma

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIV infected patients<br>HIV infected patients with asthma | |
| HIV uninfected patients<br>HIV uninfected patients with asthma | |
| HIV infected non-asthmatic patients<br>HIV infected patients without asthma | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma prevalence of HIV infected subjects currently followed at the Duke Infectious Disease (ID) Clinic compared to HIV uninfected asthma subjects identified at the Duke Asthma, Allergy and Airway Center (DAAAC). | Assessed through Asthma control questionnaire, pulse oximetry, FeNO, Spirometry, Methacholine challenge, Induced sputum for differential, serum periostin, questionnaires | 12 months | 
| Asthma phenotypic characteristics of HIV infected subjects compared to HIV uninfected asthma subjects and HIV infected non-asthmatic subjects. | Assessed through blood collection | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prospective immunological phenotyping of Th1/Th2/Th17 cytokines and T cell subsets | Assessed through blood sample collection | 12 months | 
| Retrospective immunological phenotyping (circulating cytokines) of HIV-infected patients utilizing available specimens in the Duke HIV Biorepository | The primary measure of is the quantitative difference in IL-6 between HIV-infected asthmatic subjects and HIV-infected non-asthmatic subjects. | 12 months | 
| Retrospectively determine overall asthma prevalence among HIV-infected patients | HIV-infected asthmatic subjects meeting electronic health records asthma definition Compared overall asthma prevalence in U.S. population. | 12 months |