HIV/AIDSNCT04463810
The Evaluations of Cardiovascular Changes in Long-term Treated HIV-infected Individuals
An observational study of HIV/AIDS and Cardiovascular Diseases, run by Peking Union Medical College Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV/AIDS, Cardiovascular Diseases
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: long-term treated HIV-infected patients
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Evaluations of Cardiovascular Changes in Long-term Treated HIV-infected Chinese Individuals
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.
Read the 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.
- Conditions
- HIV/AIDS, Cardiovascular Diseases
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 96 weeks
Secondary outcomes (2)
Changes from baseline T cellular activation markers
Changes from baseline T cellular activation markers (CD8CD38+ T percentage and CD8DR+ T percentage).
Measured: 0,24,48 and 96weeks
Changes from baseline serum inflammatory markers
Changes from baseline serum inflammatory markers (sCD14, D-dimer, IL-6, IP-10)
Measured: 0,24,48 and 96weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start1 Jan 2018
- Primary completionDec 2020 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LI Taisheng, Peking Union Medical College Hospital
- Investigators
- Taisheng Li, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04463810
- Sponsor's protocol ID
- CACT1808
- Status last verified
- Jul 2020
- First submitted
- 15 Jul 2018
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluations of Cardiovascular Changes in Long-term Treated HIV-infected Chinese Individuals
- ClinicalTrials.gov ID
- NCT04463810
- Acronym / sponsor ID
- CACT1808
- Conditions
- HIV/AIDS, Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 9 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- long-term treated HIV-infected patients
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants with abnormal brachial-ankle arteries measured by ultrasound at 48 weeks
Time frame: 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.
Number of Participants with abnormal brachial-ankle arteries measured by ultrasound at 96 weeks
Time frame: 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.
Number of Participants with abnormal echocardiogram results at 48 weeks
Time frame: 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.
Number of Participants with abnormal echocardiogram results at 96 weeks
Time frame: 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.
2 secondary outcomes
Changes from baseline T cellular activation markers
Time frame: 0,24,48 and 96weeks
Changes from baseline serum inflammatory markers
Time frame: 0,24,48 and 96weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Taisheng Li principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV/AIDS and Cardiovascular Diseases, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with abnormal brachial-ankle arteries measured by ultrasound at 48 weeks (time frame: 48 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2020.