Copenhagen Comorbidity in HIV Infection Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,099
- 试验地点
- 3
- 主要终点
- Coronary atherosclerosis
研究概览
简要总结
Despite efficient antiretroviral treatment for HIV infection, decrease in life expectancy remains. Excess mortality is mainly due to non-AIDS co-morbidity including cardiovascular, pulmonary, and liver related diseases. Both HIV-unrelated and HIV-related risk factors probably contribute to this pattern. At present, most evidence regarding co-morbidity in HIV infection rely on cross-study comparisons of HIV-infected persons with published population rates and few prospective studies in U.S. cohorts. Using well characterized participants from the Copenhagen General Population Study (CGPS) as controls, we aim to include >1500 HIV-infected persons in the COCOMO study to determine if co-morbidity is more prevalent or develops at a higher rate in HIV-infected persons. The study will asses 1) cardiovascular, 2) pulmonary and 3) liver-related co-morbidity using uniformly collected data in the two cohorts. The investigators aim to study the relative impact of HIV-unrelated and HIV-related factors on development of co-morbidity.
详细描述
Primary hypothesis:
Cardiovascular disease:
- HIV infection is independently associated with higher prevalence of coronary atherosclerosis (assessed by CT angiography)
Obstructive pulmonary disease:
- HIV infection is independently associated with higher prevalence of COPD, and independently associated with loss of lung function
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
- 20 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •signed informed consent
- •HIV infected
- •aged 20-100 years
排除标准
- •patients that are unable to understand information material
- •Computed tomography (CT):
- •contraindications to CT and contrast (i.e. pregnancy, renal impairment, allergy to contrast media, allergy or contraindication to beta blocking agent, body weight more than 120kg, evidence of ongoing myocardial ischemia, heart rhythm precluding EKG gating)
- •Spirometry:
- •relative contraindications to spirometry (i.e. chest, abdominal or eye surgery within the 3 months before baseline spirometry, and known retinal detachment)
- •allergy or contraindications to salbutamol (i.e. >110 bpm, or a known uncontrolled cardiac condition (i.e. unstable coronary artery disease, decompensated heart failure)
- •a respiratory illness with at least two symptoms of breathlessness, cough, wheezing, or increase in sputum production within 6 weeks.
- •Implants (e.g. pacemaker, coclea implants, insulin pumps)
- •Claustrophobia
- •Pregnancy
- •Liver Biopsy:
- •Risk of bleeding
- •Infection in puncture site
研究组 & 干预措施
HIV infected
Exposure to: Computed tomography(CT) of chest and upper abdomen, CT angiography(CTa) of heart, spirometry, mouth wash, eNO assessment, ankle brachial pressure index, fibroscan, blood sampling
干预措施: No intervention. (Other)
HIV uninfected
Exposure to: Computed tomography(CT) of chest and upper abdomen, CT angiography(CTa) of heart, spirometry, eNO assessment, ankle brachial pressure index, blood sampling
干预措施: No intervention. (Other)
结局指标
主要结局
Coronary atherosclerosis
时间窗: Baseline cross-sectional data and after 2 years follow-up
Prevalence of coronary atherosclerosis; electrocardiographic abnormalities and peripheral artery disease
Liver disease
时间窗: Baseline cross-sectional data and after 2 years follow-up
Prevalence of hepatic steatosis, steatohepatitis and liver fibrosis
Obstructive pulmonary disease
时间窗: Baseline cross-sectional data and after 2 years follow-up
Emphysema, airflow limitation,
Inflammation and clonal hematopoiesis
时间窗: Baseline cross-sectional data and after 2 years follow-up
Cytokines (e.g. IL-6, TNF-alfa), cell subsets (e.g. Tregs, Th17)
Lipid and fat metabolism
时间窗: Baseline cross-sectional data and after 2 years follow-up
Visceral adipose tissue, dyslipidemia, gut microbiota
次要结局
- Bone metabolism(Baseline data(cross-sectional data) assessed after two years)
- Emphysema, P. jirovecii colonization(Baseline data(cross-sectional data))
- Depression(Baseline data (cross-sectional data))
- Hematological abnormalities(Baseline data(cross-sectional data))
- Renal function(Baseline data(cross-sectional data))
研究者
Susanne Dam Nielsen, MD, DMSc
Professor, MD, DMSc
Rigshospitalet, Denmark