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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Unknown

Conditions: Cardiovascular Diseases; HIV/AIDS

Study type: Observational

Funder types: Other

Identifiers

NCT04463810

CACT1808

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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