Copenhagen Co-morbidity in HIV Infection Study — COCOMO  

HIV Clinical Trial

Official title: Copenhagen Co-morbidity in HIV Infection Study

Status Active, not recruiting

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 ;

Related Conditions & MeSH terms

• COPD
• CVD
• HIV
• HIV Infections
• Liver Disease
• Liver Diseases

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