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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Duke University


Information provided by (Responsible Party)
Duke University
ClinicalTrials.gov Identifier
NCT02405026

First received: December 15, 2014
Last updated: October 2, 2017
Last Verified: September 2017
History of Changes
Purpose

Purpose

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.

Condition
Asthma
HIV

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: HIV and Asthma in the Post-ART (Antiretroviral Therapy) Era

Further study details as provided by Duke University:

Primary Outcome Measures

  • 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). [ Time Frame: 12 months ]
    Assessed through Asthma control questionnaire, pulse oximetry, FeNO, Spirometry, Methacholine challenge, Induced sputum for differential, serum periostin, questionnaires
  • Asthma phenotypic characteristics of HIV infected subjects compared to HIV uninfected asthma subjects and HIV infected non-asthmatic subjects. [ Time Frame: 12 months ]
    Assessed through blood collection
Secondary Outcome Measures:
  • Prospective immunological phenotyping of Th1/Th2/Th17 cytokines and T cell subsets [ Time Frame: 12 months ]
    Assessed through blood sample collection
  • Retrospective immunological phenotyping (circulating cytokines) of HIV-infected patients utilizing available specimens in the Duke HIV Biorepository [ Time Frame: 12 months ]
    The primary measure of is the quantitative difference in IL-6 between HIV-infected asthmatic subjects and HIV-infected non-asthmatic subjects.
  • Retrospectively determine overall asthma prevalence among HIV-infected patients [ Time Frame: 12 months ]
    HIV-infected asthmatic subjects meeting electronic health records asthma definition Compared overall asthma prevalence in U.S. population.

Biospecimen Retention: Samples With DNA
serum, plasma, sputum supernatant, sputum cell pellet

Enrollment: 83
Study Start Date: December 2014
Study Completion Date: July 2017
Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)

Arms
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

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

    Eligibility

    Ages Eligible for Study: 18 Years and older  
    Sexes Eligible for Study: All  
    Accepts Healthy Volunteers: No  
    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.

    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

    contacts and locations

    Contacts and Locations

    Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

    Please refer to this study by its ClinicalTrials.gov identifier: NCT02405026

    Locations

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

    Sponsors and Collaborators

    Duke University

    Investigators

    Principal Investigator: Loretta Que, MD Duke University
    More Information

    More Information


    Responsible Party: Duke University  
    ClinicalTrials.gov Identifier: NCT02405026   History of Changes  
    Other Study ID Numbers: Pro00057348  
    Study First Received: December 15, 2014  
    Last Updated: October 2, 2017  

    Additional relevant MeSH terms:
    Asthma

    ClinicalTrials.gov processed this data on October 19, 2017
    This information is provided by ClinicalTrials.gov.