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

NCT ID: NCT02405026

Last Updated: 2017-10-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 83 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2017-07-31

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.

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

Conditions

Asthma; HIV

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

HIV infected patients

HIV infected patients with asthma

No interventions assigned to this group

HIV uninfected patients

HIV uninfected patients with asthma

No interventions assigned to this group

HIV infected non-asthmatic patients

HIV infected patients without asthma

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Loretta Que, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke Asthma Allergy and Airway Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00057348

Identifier Type: -

Identifier Source: org_study_id