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Copenhagen Comorbidity in HIV Infection Study

Copenhagen Comorbidity in HIV Infection Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02382822
Acronym
COCOMO
Enrollment
1099
Registered
2015-03-09
Start date
2015-02-01
Completion date
2035-12-31
Last updated
2026-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD, CVD, HIV, Liver Disease

Brief 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

Interventions

OTHERNo intervention.

Sponsors

Susanne Dam Nielsen, MD, DMSc
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Coronary atherosclerosisBaseline cross-sectional data and after 2 years follow-upPrevalence of coronary atherosclerosis; electrocardiographic abnormalities and peripheral artery disease
Obstructive pulmonary diseaseBaseline cross-sectional data and after 2 years follow-upEmphysema, airflow limitation,
Liver diseaseBaseline cross-sectional data and after 2 years follow-upPrevalence of hepatic steatosis, steatohepatitis and liver fibrosis
Lipid and fat metabolismBaseline cross-sectional data and after 2 years follow-upVisceral adipose tissue, dyslipidemia, gut microbiota
Inflammation and clonal hematopoiesisBaseline cross-sectional data and after 2 years follow-upCytokines (e.g. IL-6, TNF-alfa), cell subsets (e.g. Tregs, Th17)

Secondary

MeasureTime frameDescription
Emphysema, P. jirovecii colonizationBaseline data(cross-sectional data)Secondary pulmonary outcome measures
DepressionBaseline data (cross-sectional data)Major Depression Inventory Score, kynurenin/tryptophan ratio
Bone metabolismBaseline data(cross-sectional data) assessed after two yearsBone mineral density
Hematological abnormalitiesBaseline data(cross-sectional data)Anemia, trombocytopenia, leukopenia
Renal functionBaseline data(cross-sectional data)Kidney function

Countries

Denmark

Contacts

PRINCIPAL_INVESTIGATORSusanne D Nielsen, Professor, MD, DMSc

Department of Infectious Diseases, Copenhagen University Hospital - Rigshospitalet

STUDY_DIRECTORThomas L Benfield, Professor, MD, DMSc

Department of Infectious Diseases, Copenhagen University Hospital - Amager and Hvidovre

STUDY_DIRECTORKlaus F Kofoed, Professor, MD, PhD, DMSc

Department of Cardiology, Copenhagen University Hospital - Rigshospitalet

STUDY_DIRECTORLars V Køber, Professor, MD, PhD, DMSc

Department of Cardiology, Copenhagen University Hospital - Rigshospitalet

STUDY_DIRECTORBørge G Nordestgaard, Professor, MD, DMSc

Department of Clinical Biochemistry, Copenhagen University Hospital - Herlev and Gentofte

STUDY_DIRECTORShoaib Afzal, Professor, MD, DMSc

Department of Clinical Biochemistry, Copenhagen University Hospital - Herlev and Gentofte

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 13, 2026