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This is a substudy of MARCH, in which we are exploring the changes in the vascular endothelium using pulse wave tonometry (a non invasive measure of cardiac health) to measure the changes in small and large arterial elasticity in participants of the MARCH study who switch to maraviroc-based regimens over 96 weeks of follow-up.
Cardiovascular disease is increasingly recognised as a complication of HIV +/- therapies to treat it. Blood vessel elasticity, or compliance, can be depicted as the ability of the vessels to convert intermittent blood flow (cardiac ejection during systole) to continuous blood flow throughout the cardiac cycle. The compliance, or ability of vessels to accept energy, can be subdivided into elasticity of large and small vessels. Pulse wave tonometry is a non-invasive technique performed using a hand-held tonometer that generates two indices which correspond to large artery elasticity (LAE) and small artery elasticity (SAE). LAE and SAE estimates by pulse waveform analysis have previously shown greater correlation to Framingham risk when directly compared with other techniques such as flow-mediated diltation, and both LAE and SAE are associated with traditional cardiovascular risk factors (smoking, insulin resistance, hypertension).
It is unclear what the net effect of maraviroc, a chemokine-receptor blocker is on cardiovascular function.
The aims of this substudy are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | NRTI and PI |
| |
| Arm 2 | Maraviroc + PI |
| |
| Arm 3 | maraviroc + NRTI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NRTI + PI | Drug | tenofovir zidovudine abacavir lamivudine emtricitabine ritonavir darunavir atazanavir lopinavir fosamprenavir |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in small arterial elasticity (SAE) as measure by pulse wave tonometry | measured at 6 timepoints week 0, 4, 12, 24, 48, 96 | 96 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| • Mean change in large arterial elasticity (LAE) as measure by pulse wave tonometry | measured at 6 timepoints, week 0,4,12,24,48,96 | 96 weeks |
| • Changes from baseline in selected soluble markers of immune activation, coagulation, vascular and platelet function |
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Inclusion Criteria:
Exclusion Criteria:
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Participants in MARCH
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| Name | Affiliation | Role |
|---|---|---|
| Sarah L Pett, FRACP,FRCPE,PhD | Kirby Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General de Agudos "Dr. José María Ramos Mejía" | Buenos Aires | Buenos Aires | C1221ADC | Argentina | ||
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077592 | Maraviroc |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| maraviroc + PI | Drug | maraviroc ritonavir darunavir atazanavir lopinavir fosamprenavir |
|
| maraviroc + NRTI | Drug | maraviroc tenofovir zidovudine abacavir lamivudine emtricitabine |
|
stored bloods from the main study will be used to explore changes in vascular biomarkers |
| 96 weeks |
| Fundacion IDEAA |
| Buenos Aires |
| Buenos Aires |
| C1405CKC |
| Argentina |
| Hospital Italiano de Buenos Aires | Buenos Aires | Argentina |
| St. Vincent's Hospital | Sydney | New South Wales | 2010 | Australia |
| Johann Wolfgang Goethe-University Hospital, Medical HIVCENTER | Frankfurt | Frankfurt Am Main | 60590 | Germany |
| Chulalongkorn University Hospital | Bangkok | Bangkok | 10330 | Thailand |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |