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

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.

Study Overview

• Status: Completed
• Conditions: Asthma; HIV

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

• Study Type: Observational
• Enrollment (Actual): 83

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke Asthma Allergy and Airway Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
HIV infected patients; HIV infected patients with asthma
HIV uninfected patients; HIV uninfected patients with asthma
HIV infected non-asthmatic patients; HIV infected patients without asthma

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Loretta Que, MD, Duke University

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: December 15, 2014
• First Submitted That Met QC Criteria: March 27, 2015
• First Posted (Estimate): April 1, 2015

Study Record Updates

• Last Update Posted (Actual): October 3, 2017
• Last Update Submitted That Met QC Criteria: October 2, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: Pro00057348