Clinical trial NCT04463810: The Evaluations of Cardiovascular Changes in Long-term Treated HIV-infected Individuals
Official title: The Evaluations of Cardiovascular Changes in Long-term Treated HIV-infected Chinese Individuals
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV/AIDS
Cardiovascular Diseases
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2020-07-09
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: long-term treated HIV-infected patients

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants with abnormal brachial-ankle arteries measured by ultrasound at 48 weeks
timeFrame: 48 weeks
measure: Number of Participants with abnormal brachial-ankle arteries measured by ultrasound at 96 weeks
timeFrame: 96 weeks
measure: Number of Participants with abnormal echocardiogram results at 48 weeks
timeFrame: 48 weeks
measure: Number of Participants with abnormal echocardiogram results at 96 weeks
timeFrame: 96 weeks
Secondary outcomes:
measure: Changes from baseline T cellular activation markers
timeFrame: 0,24,48 and 96weeks
measure: Changes from baseline serum inflammatory markers
timeFrame: 0,24,48 and 96weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
affiliation: Peking Union Medical College Hospital
name: Taisheng Li
role: PRINCIPAL_INVESTIGATOR
References: