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

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Duke University

Status

Completed

Conditions

Asthma
HIV

Study type

Observational

Funder types

Other

Identifiers

NCT02405026
Pro00057348

Details and patient eligibility

About

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.

Full 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

Enrollment

83 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

83 participants in 3 patient groups

HIV infected patients
Description:
HIV infected patients with asthma
HIV uninfected patients
Description:
HIV uninfected patients with asthma
HIV infected non-asthmatic patients
Description:
HIV infected patients without asthma

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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