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Clinical Trial Summary

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.


Clinical Trial Description

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 Liver disease: - HIV infection is independently associated with liver steatosis, steatohepatitis and liver fibrosis Lipid and fat metabolism: - HIV infection is independently associated with alterations in adipose fat tissue and dyslipidemia Secondary hypothesis: Cardiovascular disease: - Viral load and CD4 are independently associated with coronary atherosclerosis (assessed by CT angiography) in HIV-infected individuals. - Levels of inflammatory markers can predict coronary atherosclerosis in HIV-infected individuals. - Microbial translocation and metabolism are associated with coronary atherosclerosis in HIV-infected individuals. - Endothelial dysfunction (assessed by arterial elastography) can predict coronary atherosclerosis in HIV-infected individuals Obstructive pulmonary disease: - Viral load and CD4 is independently associated with emphysema - HIV is independently associated with pulmonary hypertension (assessed by CT angiography), and obstructive lung disease is independently associated with airway obstruction - PCP colonization in HIV infected patients is independently associated with obstructive lung disease, emphysema and loss of lung function. - Inflammatory markers in HIV infected patients are associated with obstructive lung disease and loss of lung function ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02382822
Study type Observational
Source Rigshospitalet, Denmark
Contact
Status Active, not recruiting
Phase
Start date March 2015
Completion date March 2025

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