MARCH Vascular Endothelium Substudy
Information source: Kirby Institute
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cardiovascular Disease
Intervention: NRTI + PI (Drug); maraviroc + PI (Drug); maraviroc + NRTI (Drug)
Phase: N/A
Status: Active, not recruiting
Sponsored by: Kirby Institute Official(s) and/or principal investigator(s): Sarah L Pett, FRACP,FRCPE,PhD, Principal Investigator, Affiliation: Kirby Institute, UNSW
Summary
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.
Clinical Details
Official title: Maraviroc Switch Vascular Endothelium (VE) Substudy: a Substudy of MARCH
Study design: Time Perspective: Prospective
Primary outcome: Mean change in small arterial elasticity (SAE) as measure by pulse wave tonometry
Secondary outcome: • Mean change in large arterial elasticity (LAE) as measure by pulse wave tonometry• Changes from baseline in selected soluble markers of immune activation, coagulation, vascular and platelet function
Detailed description:
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:
- To compare changes in the vascular endothelium between the control arm ((N(t)RTI) plus
PI/r) and each of the maraviroc switch arms over 48 weeks of follow-up.
- To compare the changes in biomarkers and selected immunological markers between the
control arm ((N(t)RTI) plus PI/r) and each of the maraviroc switch arms over 48 weeks
of follow-up.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Enrolled prior to treatment in the parent study;
- Provision of written, informed consent for participation in the substudy
Exclusion Criteria:
- Known supraventricular tachycardia such as atrial flutter and/or fibrillation that
precludes the measurement of pulse wave using tonometry.
Locations and Contacts
Fundacion IDEAA, Buenos Aires C1405CKC, Argentina
Hospital General de Agudos "Dr. José María Ramos Mejía", Buenos Aires C1221ADC, Argentina
Hospital Italiano de Buenos Aires, Buenos Aires, Argentina
Chulalongkorn University Hospital, Bangkok 10330, Thailand
Johann Wolfgang Goethe-University Hospital, Medical HIVCENTER, Frankfurt, Frankfurt am Main 60590, Germany
St. Vincent's Hospital, Sydney, New South Wales 2010, Australia
Additional Information
Starting date: June 2012
Last updated: July 16, 2014
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