Copenhagen Comorbidity in HIV Infection Study

NCT02382822 | Active Not Recruiting DMC

• 1 other identifier: H-8-2014-004
• Study Type: observational
• Target: 1,099
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV; COPD; CVD; Liver Disease

Outcome Measures

Primary Outcomes (5)

• Coronary atherosclerosis

  Prevalence of coronary atherosclerosis; electrocardiographic abnormalities and peripheral artery disease

  Baseline cross-sectional data and after 2 years follow-up

• Obstructive pulmonary disease

  Emphysema, airflow limitation,

  Baseline cross-sectional data and after 2 years follow-up

• Liver disease

  Prevalence of hepatic steatosis, steatohepatitis and liver fibrosis

  Baseline cross-sectional data and after 2 years follow-up

• Lipid and fat metabolism

  Visceral adipose tissue, dyslipidemia, gut microbiota

  Baseline cross-sectional data and after 2 years follow-up

• Inflammation and clonal hematopoiesis

  Cytokines (e.g. IL-6, TNF-alfa), cell subsets (e.g. Tregs, Th17)

  Baseline cross-sectional data and after 2 years follow-up

Secondary Outcomes (5)

• Emphysema, P. jirovecii colonization

  Baseline data(cross-sectional data)

• Depression

  Baseline data (cross-sectional data)

• Bone metabolism

  Baseline data(cross-sectional data) assessed after two years

• Hematological abnormalities

  Baseline data(cross-sectional data)

• Renal function

  Baseline data(cross-sectional data)

Study Arms (2)

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

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

Other: No intervention.

Interventions

No intervention. OTHER

HIV infected; HIV uninfected

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HIV infected patients.

You may qualify if:

• signed informed consent
• HIV infected
• aged 20-100 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Susanne Dam Nielsen, MD, DMSc: lead

Study Sites (2)

Copenhagen University Hospital - Rigshospitalet

Copenhagen, 2100, Denmark

Location

Copenhagen University Hospital - Amager and Hvidovre

Hvidovre, Denmark

Location

Related Publications (6)

• 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.

  PMID: 33936110 DERIVED

• 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.

  PMID: 33493297 DERIVED

• 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.

  PMID: 29331988 DERIVED

• 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.

  PMID: 28857778 DERIVED

• 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.

  PMID: 28254767 DERIVED

• 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.

  PMID: 27887644 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Routine biochemistry, whole blood, plasma, peripheral blood mononuclear cells (PBMCs), DNA and RNA from buffy coat, plasma, and red blood cells (RBC).

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Liver Diseases

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Digestive System Diseases

Study Officials

• Susanne D Nielsen, Professor, MD, DMSc

  Department of Infectious Diseases, Copenhagen University Hospital - Rigshospitalet

  PRINCIPAL INVESTIGATOR

• Thomas L Benfield, Professor, MD, DMSc

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

  STUDY DIRECTOR

• Klaus F Kofoed, Professor, MD, PhD, DMSc

  Department of Cardiology, Copenhagen University Hospital - Rigshospitalet

  STUDY DIRECTOR

• Lars V Køber, Professor, MD, PhD, DMSc

  Department of Cardiology, Copenhagen University Hospital - Rigshospitalet

  STUDY DIRECTOR

• Børge G Nordestgaard, Professor, MD, DMSc

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

  STUDY DIRECTOR

• Shoaib Afzal, Professor, MD, DMSc

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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, MD, DMSc

Study Record Dates

• First Submitted: March 3, 2015
• First Posted: March 9, 2015
• Study Start: February 1, 2015
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2035
• Last Updated: April 6, 2025

Record last verified: 2025-04

Locations

DK (2)