NCT Number: NCT02382822
Copenhagen Comorbidity in HIV Infection Study
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.
This study is active but is not currently recruiting participants.
Key information
Conditions
Age range
20 year–100 year
Sex eligibility
All sexes
Study type
Observational
Primary location
Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark
About this study
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
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- signed informed consent
- HIV infected
- aged 20-100 years
Exclusion criteria
- 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.
MRI:
- Implants (e.g. pacemaker, coclea implants, insulin pumps)
- Claustrophobia
- Pregnancy
Liver Biopsy:
- Risk of bleeding
- Infection in puncture site
Treatment and study plan
Primary outcomes
-
Coronary atherosclerosis
Time frame: Baseline cross-sectional data and after 2 years follow-up
Prevalence of coronary atherosclerosis; electrocardiographic abnormalities and peripheral artery disease
-
Obstructive pulmonary disease
Time frame: Baseline cross-sectional data and after 2 years follow-up
Emphysema, airflow limitation,
-
Liver disease
Time frame: Baseline cross-sectional data and after 2 years follow-up
Prevalence of hepatic steatosis, steatohepatitis and liver fibrosis
-
Lipid and fat metabolism
Time frame: Baseline cross-sectional data and after 2 years follow-up
Visceral adipose tissue, dyslipidemia, gut microbiota
-
Inflammation and clonal hematopoiesis
Time frame: Baseline cross-sectional data and after 2 years follow-up
Cytokines (e.g. IL-6, TNF-alfa), cell subsets (e.g. Tregs, Th17)
Secondary outcomes
-
Emphysema, P. jirovecii colonization
Time frame: Baseline data(cross-sectional data)
Secondary pulmonary outcome measures
-
Depression
Time frame: Baseline data (cross-sectional data)
Major Depression Inventory Score, kynurenin/tryptophan ratio
-
Bone metabolism
Time frame: Baseline data(cross-sectional data) assessed after two years
Bone mineral density
-
Hematological abnormalities
Time frame: Baseline data(cross-sectional data)
Anemia, trombocytopenia, leukopenia
-
Renal function
Time frame: Baseline data(cross-sectional data)
Kidney function
Sponsors and collaborators
Lead sponsor
Susanne Dam Nielsen, MD, DMSc
Other
Registry information
Acronym: COCOMO
Important dates
- Study start
- 2015
- Primary completion
- 2026
- Study completion
- 2035
- First posted
- Mar 9, 2015
- Registry last updated
- Apr 6, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
deLIVER: Direct Acting Antiviral Effects on the Liver
NCT02938013
Digestive System Diseases, HCV Coinfection
Baltimore, Maryland, United States
View Trial DetailsHIV+ Alveolar Macrophage Oxidant-mediated Apoptosis of Pulmonary Endothelium
NCT02056158
Behavior, COPD
New York, United States
View Trial DetailsHIV-related Accelerated Aging of the Airway Epithelium
NCT01974219
Behavior, COPD
New York, United States
View Trial DetailsTranslation Evaluation of Aging, Inflammation and HIV in Lung Function (TEAL)
NCT02154880
Aging, COPD
Pittsburgh, Pennsylvania, United States
View Trial Details