NCT02382822

Copenhagen Comorbidity in HIV Infection Study

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,099 (actual)
• Sponsor: Susanne Dam Nielsen, MD, DMSc · Academic / Other
• Sex: All
• Age: 20 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• HIV
• COPD
• CVD
• Liver Disease

Interventions

Type	Name	Description
OTHER	No intervention.

Timeline

• Start date: 2015-02-01
• Primary completion: 2026-12-31
• Completion: 2035-12-31
• First posted: 2015-03-09
• Last updated: 2025-04-06

Locations

2 sites across 1 country: Denmark