Clinical trial NCT02405026: Determine the Prevalence and Severity of Asthma in HIV (Human Immunodeficiency Virus) Infected Patients
Official title: HIV and Asthma in the Post-ART (Antiretroviral Therapy) Era
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
HIV
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2015-04-01
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: HIV infected patients. Patients will be identified from the populations of the Duke Infectious Disease Clinic, and surrounding communities.

HIV unifected patients. Patients will be identified through the Duke Asthma, Allergy and Airway Center, as well as from primary care physicians, and surrounding communities.

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: 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).
timeFrame: 12 months
measure: Asthma phenotypic characteristics of HIV infected subjects compared to HIV uninfected asthma subjects and HIV infected non-asthmatic subjects.
timeFrame: 12 months
Secondary outcomes:
measure: Prospective immunological phenotyping of Th1/Th2/Th17 cytokines and T cell subsets
timeFrame: 12 months
measure: Retrospective immunological phenotyping (circulating cytokines) of HIV-infected patients utilizing available specimens in the Duke HIV Biorepository
timeFrame: 12 months
measure: Retrospectively determine overall asthma prevalence among HIV-infected patients
timeFrame: 12 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Asthma Allergy and Airway Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Loretta Que, MD
role: PRINCIPAL_INVESTIGATOR
References: