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

Asthma Clinical Trial

Official title:

HIV and Asthma in the Post-ART (Antiretroviral Therapy) Era

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02405026
• Other study ID #: Pro00057348
• Status: Completed
• Phase: N/A
• First received: December 15, 2014
• Last updated: October 2, 2017
• Start date: December 2014
• Est. completion date: July 2017

Study information

• Verified date: September 2017
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• HIV

Locations

Country	Name	City	State
United States	Duke Asthma Allergy and Airway Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Prospective immunological phenotyping of Th1/Th2/Th17 cytokines and T cell subsets	Assessed through blood sample collection	12 months
Secondary	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
Secondary	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