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

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Susanne Dam Nielsen, MD, DMSc, Rigshospitalet, Denmark

Study Description

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.

Condition or disease	Intervention/treatment
HIV COPD CVD Liver Disease	Other: No intervention.

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

Study Design

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

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

Eligibility Criteria

Information from the National Library of Medicine

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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

Study Population

HIV infected patients.

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

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

Locations

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Denmark
University Hospital of Copenhagen
Copenhagen, Denmark, 2100

Sponsors and Collaborators

Rigshospitalet, Denmark

Investigators

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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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.

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.

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.

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.

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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

Additional relevant MeSH terms:

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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

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