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

NCT02405026 | Completed

• 1 other identifier: Pro00057348
• Study Type: observational
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; HIV

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Prospective immunological phenotyping of Th1/Th2/Th17 cytokines and T cell subsets

  12 months

• Retrospective immunological phenotyping (circulating cytokines) of HIV-infected patients utilizing available specimens in the Duke HIV Biorepository

  12 months

• Retrospectively determine overall asthma prevalence among HIV-infected patients

  12 months

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Asthma Allergy and Airway Center

Durham, North Carolina, 27705, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

serum, plasma, sputum supernatant, sputum cell pellet

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Loretta Que, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2014
• First Posted: April 1, 2015
• Study Start: December 1, 2014
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: October 3, 2017

Record last verified: 2017-09

Locations

US (1)