Copenhagen Comorbidity in HIV Infection Study
- Conditions
- CVDHIVLiver DiseaseCOPD
- Interventions
- Other: No intervention.
- Registration Number
- NCT02382822
- Lead Sponsor
- Susanne Dam Nielsen, MD, DMSc
- 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
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
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1099
- signed informed consent
- HIV infected
- aged 20-100 years
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description HIV infected No intervention. 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 HIV uninfected No intervention. Exposure to: Computed tomography(CT) of chest and upper abdomen, CT angiography(CTa) of heart, spirometry, eNO assessment, ankle brachial pressure index, blood sampling
- Primary Outcome Measures
Name Time Method Liver disease Baseline cross-sectional data and after 2 years follow-up Prevalence of hepatic steatosis, steatohepatitis and liver fibrosis
Coronary atherosclerosis Baseline cross-sectional data and after 2 years follow-up Prevalence of coronary atherosclerosis; electrocardiographic abnormalities and peripheral artery disease
Obstructive pulmonary disease Baseline cross-sectional data and after 2 years follow-up Emphysema, airflow limitation,
Inflammation and clonal hematopoiesis 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 Baseline cross-sectional data and after 2 years follow-up Visceral adipose tissue, dyslipidemia, gut microbiota
- Secondary Outcome Measures
Name Time Method Bone metabolism Baseline data(cross-sectional data) assessed after two years Bone mineral density
Depression Baseline data (cross-sectional data) Major Depression Inventory Score, kynurenin/tryptophan ratio
Hematological abnormalities Baseline data(cross-sectional data) Anemia, trombocytopenia, leukopenia
Renal function Baseline data(cross-sectional data) Kidney function
Emphysema, P. jirovecii colonization Baseline data(cross-sectional data) Secondary pulmonary outcome measures
Trial Locations
- Locations (2)
Copenhagen University Hospital - Rigshospitalet
🇩🇰Copenhagen, Denmark
Copenhagen University Hospital - Amager and Hvidovre
🇩🇰Hvidovre, Denmark