Cardiovascular and cerebrovascular disease Circulatory System Cardiovascular and cerebrovascular disease
Conditions
Interventions
The primary study exposures are HIV infection, CMV reactivation, and markers of inflammation and endothelial dysfunction. HIV tested at baseline in all participants (ART patient and HIV uninfected com
Sponsors
GlaxoSmithKline
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged => 35 years 2. Resident in Blantyre 3. HIV-infected patients must further be ART-naïve or initiated ART <10 days prior to enrolment 4. Initiating standard first-line ART (in Malawi this is: TDF/3TC/EFV) 5. Adult controls must further be HIV uninfected
Exclusion criteria
Exclusion criteria: 1. Clinical history of CVD/CBD 2. Pregnant 3. Critically ill or have symptomatic anaemia at enrolment 4. Enrolled in an intervention study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Carotid intima media thickness (cIMT) is assessed by ultrasonography at baseline and 24 months 2. Carotid femoral pulse wave velocity (PWV) is assessed using a Vicorder at baseline, 6, 12, 18, 24, 30 and 26 months | — |
Secondary
| Measure | Time frame |
|---|---|
| All secondary outcomes are reviewed by an Endpoint Review Committee, comprised of medical experts. Retrospective assessment of outcomes deceased cases is done by medical record review, or by verbal autopsy if the individual died > 4 weeks after hospital discharge (or with no hospital admission). Verbal autopsy is conducted using a standardized WHO assessment tool 1. Stroke is measured at all occurrences by clinical assessment with standard protocols with MRI confirmation 2. Myocardial infarction (MI) is measured at all occurrences by clinical assessment with standard protocols, and ECG confirmation 3. Unstable angina is measured at all occurrences by clinical assessment with standard protocols, and ECG confirmation 4. Peripheral vascular disease (PVD) is measured at baseline, 6, 12, 18, 24, 30 and 36 months by calculation of ankle brachial pressure index (ABPI), which is assessed by sphygmomanometer and doppler ultrasound. A change of >0.15 ABPI from baseline is considered clinically significant PVD 5. All cause death or vascular death is measured at all occurrences. For deaths occurring within 4 weeks of hospital admissions, cause of death will be assessed by medical record review using standardized protocols. Deaths occurring >4 week post hospital discharge (or with no hospital admission) will be assessed by verbal autopsy 6. Immune Reconstitution Syndrome [IRIS] vasculopathy is measured at all occurrences within 6 months of the baseline visit. It is defined as a vascular event (ex. stroke, MI or unstable angina) accompanied by a decrease in viral load >1 log10 copies from baseline | — |
Countries
Malawi
Contacts
Public ContactIngrid;Laura Peterson;Benjamin
;
Outcome results
None listed