Copenhagen Comorbidity in HIV Infection Study

NCT ID: NCT02382822

Last Updated: 2025-04-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 1099 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-02-01
• Study Completion Date: 2035-12-31

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

Conditions

HIV; COPD; CVD; Liver Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No intervention.

Intervention Type: OTHER

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

No intervention.

Intervention Type: OTHER

Interventions

No intervention.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Susanne Dam Nielsen, MD, DMSc

OTHER

Sponsor Role: lead

Responsible Party

Susanne Dam Nielsen, MD, DMSc

Professor, MD, DMSc

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Susanne D Nielsen, Professor, MD, DMSc

Role: PRINCIPAL_INVESTIGATOR

Department of Infectious Diseases, Copenhagen University Hospital - Rigshospitalet

Thomas L Benfield, Professor, MD, DMSc

Role: STUDY_DIRECTOR

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

Klaus F Kofoed, Professor, MD, PhD, DMSc

Role: STUDY_DIRECTOR

Department of Cardiology, Copenhagen University Hospital - Rigshospitalet

Lars V Køber, Professor, MD, PhD, DMSc

Role: STUDY_DIRECTOR

Department of Cardiology, Copenhagen University Hospital - Rigshospitalet

Børge G Nordestgaard, Professor, MD, DMSc

Role: STUDY_DIRECTOR

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

Shoaib Afzal, Professor, MD, DMSc

Role: STUDY_DIRECTOR

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

Locations

Copenhagen University Hospital - Rigshospitalet

Copenhagen, , Denmark

Copenhagen University Hospital - Amager and Hvidovre

Hvidovre, , Denmark

Countries

Denmark

References

Thudium RF, Ringheim H, Ronit A, Hoel H, Benfield T, Mocroft A, Gerstoft J, Troseid M, Borges AH, Ostrowski SR, Vestbo J, Nielsen SD. Independent Associations of Tumor Necrosis Factor-Alpha and Interleukin-1 Beta With Radiographic Emphysema in People Living With HIV. Front Immunol. 2021 Apr 14;12:668113. doi: 10.3389/fimmu.2021.668113. eCollection 2021.

Reference Type: DERIVED

PMID: 33936110 (View on PubMed)

Kirkegaard-Klitbo DM, Thomsen MT, Gelpi M, Bendtsen F, Nielsen SD, Benfield T. Hepatic Steatosis Associated With Exposure to Elvitegravir and Raltegravir. Clin Infect Dis. 2021 Aug 2;73(3):e811-e814. doi: 10.1093/cid/ciab057.

Reference Type: DERIVED

PMID: 33493297 (View on PubMed)

Ronit A, Lundgren J, Afzal S, Benfield T, Roen A, Mocroft A, Gerstoft J, Nordestgaard BG, Vestbo J, Nielsen SD; Copenhagen Co-morbidity in HIV infection (COCOMO) study group. Airflow limitation in people living with HIV and matched uninfected controls. Thorax. 2018 May;73(5):431-438. doi: 10.1136/thoraxjnl-2017-211079. Epub 2018 Jan 13.

Reference Type: DERIVED

PMID: 29331988 (View on PubMed)

Ronit A, Kristensen T, Klitbo DM, Gelpi M, Kalhauge A, Benfield T, Gerstoft J, Lundgren J, Vestbo J, Kofoed KF, Nielsen SD. Incidental lung cancers and positive computed tomography images in people living with HIV. AIDS. 2017 Sep 10;31(14):1973-1977. doi: 10.1097/QAD.0000000000001600.

Reference Type: DERIVED

PMID: 28857778 (View on PubMed)

Ronit A, Mathiesen IH, Gelpi M, Benfield T, Gerstoft J, Pressler T, Christiansen A, Lundgren J, Vestbo J, Dam Nielsen S. Small airway dysfunction in well-treated never-smoking HIV-infected individuals. Eur Respir J. 2017 Mar 2;49(3):1602186. doi: 10.1183/13993003.02186-2016. Print 2017 Mar. No abstract available.

Reference Type: DERIVED

PMID: 28254767 (View on PubMed)

Ronit A, Haissman J, Kirkegaard-Klitbo DM, Kristensen TS, Lebech AM, Benfield T, Gerstoft J, Ullum H, Kober L, Kjaer A, Kofoed K, Vestbo J, Nordestgaard B, Lundgren J, Nielsen SD. Copenhagen comorbidity in HIV infection (COCOMO) study: a study protocol for a longitudinal, non-interventional assessment of non-AIDS comorbidity in HIV infection in Denmark. BMC Infect Dis. 2016 Nov 26;16(1):713. doi: 10.1186/s12879-016-2026-9.

Reference Type: DERIVED

PMID: 27887644 (View on PubMed)

Other Identifiers

H-8-2014-004

Identifier Type: -

Identifier Source: org_study_id