Copenhagen Co-morbidity in HIV Infection Study

HIV Clinical Trial

— COCOMO  

Official title:

Copenhagen Co-morbidity in HIV Infection Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02382822
• Other study ID #: Sponsor- Rigshospitalet
• Status: Active, not recruiting
• Start date: March 2015
• Est. completion date: March 2025

Study information

• Verified date: April 2024
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 1500
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD
• CVD
• HIV
• HIV Infections
• Liver Disease
• Liver Diseases

Intervention

Other:
• No intervention.

Locations

Country	Name	City	State
Denmark	University Hospital of Copenhagen	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coronary atherosclerosis	Prevalence of coronary atherosclerosis; electrocardiographic abnormalities and peripheral artery disease	Baseline cross-sectional data and after 2 years follow-up
Primary	Obstructive pulmonary disease	Emphysema, airflow limitation,	Baseline cross-sectional data and after 2 years follow-up
Primary	Liver disease	Prevalence of hepatic steatosis, steatohepatitis and liver fibrosis	Baseline cross-sectional data and after 2 years follow-up
Primary	Lipid and fat metabolism	Visceral adipose tissue, dyslipidemia, gut microbiota	Baseline cross-sectional data and after 2 years follow-up
Primary	Inflammation and clonal hematopoiesis	Cytokines (e.g. IL-6, TNF-alfa), cell subsets (e.g. Tregs, Th17)	Baseline cross-sectional data and after 2 years follow-up
Secondary	Emphysema, P. jirovecii colonization	Secondary pulmonary outcome measures	Baseline data(cross-sectional data)
Secondary	Depression	Major Depression Inventory Score, kynurenin/tryptophan ratio	Baseline data (cross-sectional data)
Secondary	Bone metabolism	Bone mineral density	Baseline data(cross-sectional data) assessed after two years
Secondary	Hematological abnormalities	Anemia, trombocytopenia, leukopenia	Baseline data(cross-sectional data)
Secondary	Renal function	Kidney function	Baseline data(cross-sectional data)