Copenhagen Co-morbidity in HIV Infection Study (COCOMO)
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ClinicalTrials.gov Identifier: NCT02382822 |
Recruitment Status :
Active, not recruiting
First Posted : March 9, 2015
Last Update Posted : August 26, 2020
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Condition or disease | Intervention/treatment |
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HIV COPD CVD Liver Disease | Other: No intervention. |
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 Type : | Observational |
Estimated Enrollment : | 1500 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Copenhagen Co-morbidity in HIV Infection Study |
Study Start Date : | March 2015 |
Estimated Primary Completion Date : | March 2025 |
Estimated Study Completion Date : | March 2025 |
Group/Cohort | Intervention/treatment |
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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
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Other: No intervention. |
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
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Other: No intervention. |
- 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)
- 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
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- signed informed consent
- patients that are unable to understand information material
- HIV infected
Exclusion Criteria:
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02382822
Denmark | |
University Hospital of Copenhagen | |
Copenhagen, Denmark, 2100 |
Study Director: | Andreas Ronit, MD | Department of Infectious Diseases | |
Study Director: | Ditte M Kirkegaard-Klitbo, MD | Department of Infectious Diseases | |
Study Director: | Marco Gelpi, MD | Department of Infectious Diseases | |
Study Director: | Andreas D Knudsen, MD | Department of Infectious Diseases | |
Study Director: | Rebekka F Thudium, MD | Department of Infectious Diseases | |
Study Director: | Malene Hove-Skovsgaard, MD | Department of Infectious Diseases |
Responsible Party: | Susanne Dam Nielsen, MD, DMSc, MD, Professor, Rigshospitalet, Denmark |
ClinicalTrials.gov Identifier: | NCT02382822 |
Other Study ID Numbers: |
Sponsor- Rigshospitalet |
First Posted: | March 9, 2015 Key Record Dates |
Last Update Posted: | August 26, 2020 |
Last Verified: | August 2020 |
HIV Infections Liver Diseases Infections Blood-Borne Infections Communicable Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases Digestive System Diseases |