Copenhagen Comorbidity in HIV Infection Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 1,099
- Locations
- 2
- Primary Endpoint
- Coronary atherosclerosis
Study Overview
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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 20 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •Implants (e.g. pacemaker, coclea implants, insulin pumps)
- •Claustrophobia
- •Pregnancy
- •Liver Biopsy:
- •Risk of bleeding
- •Infection in puncture site
Arms & Interventions
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
Intervention: No intervention. (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
Intervention: No intervention. (Other)
Outcomes
Primary Outcomes
Coronary atherosclerosis
Time Frame: Baseline cross-sectional data and after 2 years follow-up
Prevalence of coronary atherosclerosis; electrocardiographic abnormalities and peripheral artery disease
Liver disease
Time Frame: Baseline cross-sectional data and after 2 years follow-up
Prevalence of hepatic steatosis, steatohepatitis and liver fibrosis
Obstructive pulmonary disease
Time Frame: Baseline cross-sectional data and after 2 years follow-up
Emphysema, airflow limitation,
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)
Lipid and fat metabolism
Time Frame: Baseline cross-sectional data and after 2 years follow-up
Visceral adipose tissue, dyslipidemia, gut microbiota
Secondary Outcomes
- Bone metabolism(Baseline data(cross-sectional data) assessed after two years)
- Emphysema, P. jirovecii colonization(Baseline data(cross-sectional data))
- Depression(Baseline data (cross-sectional data))
- Hematological abnormalities(Baseline data(cross-sectional data))
- Renal function(Baseline data(cross-sectional data))
Investigators
Susanne Dam Nielsen, MD, DMSc
Professor, MD, DMSc
Rigshospitalet, Denmark