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

NCT04463810 | Unknown DMC

• 1 other identifier: CACT1808
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV/AIDS; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (2)

• Changes from baseline T cellular activation markers

  0,24,48 and 96weeks

• Changes from baseline serum inflammatory markers

  0,24,48 and 96weeks

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

long-term treated HIV-infected patients

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, 100730, China

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Taisheng Li

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Department of Infectious Diseases

Study Record Dates

• First Submitted: July 15, 2018
• First Posted: July 9, 2020
• Study Start: January 1, 2018
• Primary Completion: December 1, 2020
• Study Completion: September 1, 2021
• Last Updated: July 9, 2020

Record last verified: 2020-07

Locations

CN (1)