Status:
UNKNOWN
The Evaluations of Cardiovascular Changes in Long-term Treated HIV-infected Individuals
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
HIV/AIDS
Cardiovascular Diseases
Eligibility:
All Genders
18-65 years
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 year...
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 follow...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2021
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04463810
Start Date
January 1 2018
End Date
September 1 2021
Last Update
July 9 2020
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, China, 100730