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

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ClinicalTrials.gov Identifier: NCT02405026
Recruitment Status : Completed
First Posted : April 1, 2015
Last Update Posted : October 3, 2017
Sponsor:
Information provided by (Responsible Party):
Duke University

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.

Condition or disease
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

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Study Type : Observational
Actual Enrollment : 83 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: HIV and Asthma in the Post-ART (Antiretroviral Therapy) Era
Study Start Date : December 2014
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma HIV/AIDS

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



Primary Outcome Measures :
  1. 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

  2. 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 :
  1. Prospective immunological phenotyping of Th1/Th2/Th17 cytokines and T cell subsets [ Time Frame: 12 months ]
    Assessed through blood sample collection

  2. 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.

  3. 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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02405026


Locations
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United States, North Carolina
Duke Asthma Allergy and Airway Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Loretta Que, MD Duke University

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02405026     History of Changes
Other Study ID Numbers: Pro00057348
First Posted: April 1, 2015    Key Record Dates
Last Update Posted: October 3, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases