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Copenhagen Comorbidity in HIV Infection Study

Study acronym: COCOMO
StatusActive, Not Recruiting
PhaseNot specified
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv10
  2. Lead sponsor: Rigshospitalet, Denmark to Susanne Dam Nielsen, MD, DMScv9 Show 7 more changesShow less
    • Primary completion date: Mar 2025 to Dec 31, 2026
    • Enrollment target: estimated 1500 to confirmed 1099
    • Study sites: 1 to 2
    • Study completion date: Mar 2025 to Dec 31, 2035
    • Start date: Mar 2015 to Feb 1, 2015
    • Study title revised
    • Eligibility criteria expanded, about 4 words
  3. 2 versions Re-verified since Aug 24, 2020, no change to tracked fieldsv7-v8
  4. Primary endpoints: 3 to 5
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints: 1 to 5
    • Study description expanded, about 35 words
    v6
  5. Primary and study completion dates: Mar 2017 to Mar 2025
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. 2 versions Re-verified since Nov 4, 2015, no change to tracked fieldsv3-v4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT02382822
Lead Sponsor Susanne Dam Nielsen, MD, DMSc
Conditions
(from sponsor)		 HIV, COPD, CVD, Liver Disease
Related terms Liver Diseases, Pulmonary Disease, Chronic Obstructive
Enrollment 1,099 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov