ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	22 April 2024
Main ID:	NCT02382822
Date of registration:	03/03/2015
Prospective Registration:	No
Primary sponsor:	Rigshospitalet, Denmark
Public title:	Copenhagen Co-morbidity in HIV Infection Study COCOMO
Scientific title:	Copenhagen Co-morbidity in HIV Infection Study
Date of first enrolment:	March 2015
Target sample size:	1500
Recruitment status:	Active, not recruiting
URL:	https://clinicaltrials.gov/ct2/show/NCT02382822
Study type:	Observational
Study design:
Phase:

Countries of recruitment
Denmark

Contacts

Name:	Marco Gelpi, MD
Address:
Telephone:
Email:
Affiliation:	Department of Infectious Diseases

Name:	Andreas Ronit, MD
Address:
Telephone:
Email:
Affiliation:	Department of Infectious Diseases

Name:	Rebekka F Thudium, MD
Address:
Telephone:
Email:
Affiliation:	Department of Infectious Diseases

Name:	Andreas D Knudsen, MD
Address:
Telephone:
Email:
Affiliation:	Department of Infectious Diseases

Name:	Ditte M Kirkegaard-Klitbo, MD
Address:
Telephone:
Email:
Affiliation:	Department of Infectious Diseases

Name:	Malene Hove-Skovsgaard, MD
Address:
Telephone:
Email:
Affiliation:	Department of Infectious Diseases

Key inclusion & exclusion criteria

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

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Liver Disease

COPD

CVD

HIV

Intervention(s)

Other: No intervention.

Primary Outcome(s)

Lipid and fat metabolism [Time Frame: Baseline cross-sectional data and after 2 years follow-up]

Inflammation and clonal hematopoiesis [Time Frame: Baseline cross-sectional data and after 2 years follow-up]

Obstructive pulmonary disease [Time Frame: Baseline cross-sectional data and after 2 years follow-up]

Coronary atherosclerosis [Time Frame: Baseline cross-sectional data and after 2 years follow-up]

Liver disease [Time Frame: Baseline cross-sectional data and after 2 years follow-up]

Secondary Outcome(s)

Emphysema, P. jirovecii colonization [Time Frame: Baseline data(cross-sectional data)]

Renal function [Time Frame: Baseline data(cross-sectional data)]

Bone metabolism [Time Frame: Baseline data(cross-sectional data) assessed after two years]

Hematological abnormalities [Time Frame: Baseline data(cross-sectional data)]

Depression [Time Frame: Baseline data (cross-sectional data)]

Secondary ID(s)

Sponsor- Rigshospitalet

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.