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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

Page last updated: August 23, 2015

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