title: 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.
abstract: BACKGROUND
  Modern combination antiretroviral therapy (cART) has improved survival for people living with HIV (PLWHIV). Non-AIDS comorbidities have replaced opportunistic infections as leading causes of mortality and morbidity, and are becoming a key health concern as this population continues to age. The aim of this study is to estimate the prevalence and incidence of non-AIDS comorbidity among PLWHIV in Denmark in the cART era and to determine risk factors contributing to the pathogenesis. The study primarily targets cardiovascular, respiratory, and hepatic non-AIDS comorbidity.
  
  
  METHODS
  The Copenhagen comorbidity in HIV-infection (COCOMO) study is an observational, longitudinal cohort study. The study was initiated in 2015 and recruitment is ongoing with the aim of including 1500 PLWHIV from the Copenhagen area. Follow-up examinations after 2 and 10 years are planned. Uninfected controls are derived from the Copenhagen General Population Study (CGPS), a cohort study including 100,000 uninfected participants from the same geographical region. Physiological and biological measures including blood pressure, ankle-brachial index, electrocardiogram, spirometry, exhaled nitric oxide, transient elastography of the liver, computed tomography (CT) angiography of the heart, unenhanced CT of the chest and upper abdomen, and a number of routine biochemical analysis are uniformly collected in participants from the COCOMO study and the CGPS. Plasma, serum, buffy coat, peripheral blood mononuclear cells (PBMC), urine, and stool samples are collected in a biobank for future studies. Data will be updated through periodical linking to national databases.
  
  
  CONCLUSIONS
  As life expectancy for PLWHIV improves, it is essential to study long-term impact of HIV and cART. We anticipate that findings from this cohort study will increase knowledge on non-AIDS comorbidity in PLWHIV and identify targets for future interventional trials. Recognizing the demographic, clinical and pathophysiological characteristics of comorbidity in PLWHIV may help inform development of new guidelines and enable us to move forward to a more personalized HIV care.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT02382822 .
authors.affiliation: Viro-immunology Research Unit, Department of Infectious Diseases 8632, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Andreas
authors.initials: A
authors.lastname: Ronit
authors.affiliation: Viro-immunology Research Unit, Department of Infectious Diseases 8632, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Judith
authors.initials: J
authors.lastname: Haissman
authors.affiliation: Viro-immunology Research Unit, Department of Infectious Diseases 8632, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.|Department of Infectious Diseases, Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Ditte Marie
authors.initials: DM
authors.lastname: Kirkegaard-Klitbo
authors.affiliation: Department of Radiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Thomas Skårup
authors.initials: TS
authors.lastname: Kristensen
authors.affiliation: Department of Infectious Diseases, Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Anne-Mette
authors.initials: AM
authors.lastname: Lebech
authors.affiliation: Department of Infectious Diseases, Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Thomas
authors.initials: T
authors.lastname: Benfield
authors.affiliation: Viro-immunology Research Unit, Department of Infectious Diseases 8632, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Jan
authors.initials: J
authors.lastname: Gerstoft
authors.affiliation: Department of Clinical Immunology 2034, Blood Bank, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Henrik
authors.initials: H
authors.lastname: Ullum
authors.affiliation: Department of Cardiology, The Heart Centre, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Lars
authors.initials: L
authors.lastname: Køber
authors.affiliation: Department of clinical physiology, Nuclear Medicine and PET, Rigshospitalet, Copenhagen, Denmark.
authors.forename: Andreas
authors.initials: A
authors.lastname: Kjær
authors.affiliation: Department of Radiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.|Department of Cardiology, The Heart Centre, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Klaus
authors.initials: K
authors.lastname: Kofoed
authors.affiliation: Division of Infection, Immunity and Respiratory Medicine, University Hospital South Manchester NHS Foundation Trust and The University of Manchester, Manchester, UK.
authors.forename: Jørgen
authors.initials: J
authors.lastname: Vestbo
authors.affiliation: Department of Clinical Biochemistry, Herlev and Gentofte Hospital, University of Copenhagen, Herlev, Denmark.|Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Børge
authors.initials: B
authors.lastname: Nordestgaard
authors.affiliation: CHIP, Department of Infectious Diseases, Section 2100, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Jens
authors.initials: J
authors.lastname: Lundgren
authors.affiliation: Viro-immunology Research Unit, Department of Infectious Diseases 8632, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark. sdn@dadlnet.dk.
authors.forename: Susanne Dam
authors.initials: SD
authors.lastname: Nielsen
mesh_terms: D000163:Acquired Immunodeficiency Syndrome / Q000453:epidemiology; D000328:Adult; D001794:Blood Pressure; D002318:Cardiovascular Diseases / Q000000981:diagnostic imaging / Q000453:epidemiology; D015331:Cohort Studies; D015897:Comorbidity; D000072226:Computed Tomography Angiography; D003718:Denmark / Q000453:epidemiology; D015658:HIV Infections / Q000188:drug therapy / Q000453:epidemiology*; D006801:Humans; D007963:Leukocytes, Mononuclear; D008017:Life Expectancy; D008107:Liver Diseases / Q000453:epidemiology; D008137:Longitudinal Studies; D064887:Observational Studies as Topic; D012307:Risk Factors
keywords: Cardiovascular diseases; Comorbidity; HIV; Inflammation; Liver related diseases; Respiratory disease