HIV and Asthma in the Post-ART (Antiretroviral Therapy) Era
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- 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).
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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).
时间窗: 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.
时间窗: 12 months
Assessed through blood collection
次要结局
- Retrospective immunological phenotyping (circulating cytokines) of HIV-infected patients utilizing available specimens in the Duke HIV Biorepository(12 months)
- Retrospectively determine overall asthma prevalence among HIV-infected patients(12 months)
- Prospective immunological phenotyping of Th1/Th2/Th17 cytokines and T cell subsets(12 months)