The Evaluations of Cardiovascular Changes in Long-term Treated HIV-infected Individuals

Cardiovascular Diseases Clinical Trial

Official title:

The Evaluations of Cardiovascular Changes in Long-term Treated HIV-infected Chinese Individuals

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04463810
• Other study ID #: CACT1808
• Status: Active, not recruiting
• Start date: January 1, 2018
• Est. completion date: September 2021

Study information

• Verified date: July 2020
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The present study aims to evaluate the cardiovascular changes in long-term virologically controlled HIV patients. All the participants have been treated and have been undetected for at least five years. Vascular ultrasound and echo will be carried out at 0, 24, 48 and 96 weeks of follow-up.

Description:

Previous studies have indicated that chronic HIV infection has resulted the diastolic cardiac dysfunction. In this study, 500 long-term virologically controlled HIV-infected individuals will be followed for two years, and evaluated at 0, 24, 48 and 96 weeks of follow-up. At each visiting point, ultrasound evaluation of carotid and vertebral arteries and the heart function will be carried out and compared.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: September 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Provision of signed and dated informed consent form

• Willingness and availability to engage in study activities for the duration of the study

• Age between 18-65

• Documented HIV-1 infection (confirmed by Western blot)

• regular ART treated for over 240 weeks

• HIV-RNA < 200 cp/ml

Exclusion Criteria:

• Pregnancy or breastfeeding or anticipated pregnancy in two years

• History of AIDS-defining illness

• Virological failure during the ART ( Definition of virolgocial failure: plasma HIV-RNA > 200 cp/ml upon continuous HARRT)

• Hemoglobin < 9g/dl;or peripheral white blood cell counts < 2000/µl;or neutrophil counts < 1000 /µl;or platelet count < 75,000/µl;

• Liver disease (transaminase and alkaline phosphatase levels more than three times the upper limit of the normal range (ULN), bilirubin level more than 2.5 times the ULN)

• Chronic kidney disease (serum creatinine level more than 1.5 times the ULN)

• Patients with a history of injection drug usage

• Patients with a history of mental disorders

Related Conditions & MeSH terms

• Cardiovascular Diseases
• HIV/AIDS

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with abnormal brachial-ankle arteries measured by ultrasound at 48 weeks	The ankle-brachial index (ABI) and pulse wave velocity (PWV) including right and left brachial-ankle are aceessed through ultrasound. The measured value will be documented and evaluated for abnormality.	48 weeks
Primary	Number of Participants with abnormal brachial-ankle arteries measured by ultrasound at 96 weeks	The ankle-brachial index (ABI) and pulse wave velocity (PWV) including right and left brachial-ankle are aceessed through ultrasound. The measured value will be documented and evaluated for abnormality.	96 weeks
Primary	Number of Participants with abnormal echocardiogram results at 48 weeks	Echocardiogram indicators include left ventricular end-diastolic diameter, left ventricular end-systolic diameter, left ventricular fractional shortening (LVFS), ejection fraction (EF), E/A ratio, E-wave deceleration time (EDT), isovolumetric relaxation time (IVRT), tricuspid regurgitation velocity (TRV), Pulmonary artery systolic pressure, Interventricular septal (IVS ) thickness, left ventricular posterior wall thickness, the present of valve abnormalities/ myocardial ischemia/ pericardial effusion. The measured value will be documented and evaluated for abnormality.	48 weeks
Primary	Number of Participants with abnormal echocardiogram results at 96 weeks	Echocardiogram indicators include left ventricular end-diastolic diameter, left ventricular end-systolic diameter, left ventricular fractional shortening (LVFS), ejection fraction (EF), E/A ratio, E-wave deceleration time (EDT), isovolumetric relaxation time (IVRT), tricuspid regurgitation velocity (TRV), Pulmonary artery systolic pressure, Interventricular septal (IVS ) thickness, left ventricular posterior wall thickness, the present of valve abnormalities/ myocardial ischemia/ pericardial effusion. The measured value will be documented and evaluated for abnormality.	96 weeks
Secondary	Changes from baseline T cellular activation markers	Changes from baseline T cellular activation markers (CD8CD38+ T percentage and CD8DR+ T percentage).	0,24,48 and 96weeks
Secondary	Changes from baseline serum inflammatory markers	Changes from baseline serum inflammatory markers (sCD14, D-dimer, IL-6, IP-10)	0,24,48 and 96weeks