Clinical trial NCT01585753: MARCH Vascular Endothelium Substudy
Official title: Maraviroc Switch Vascular Endothelium (VE) Substudy: a Substudy of MARCH
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Disease
Keywords: cardiovascular function
maraviroc
Lead sponsor: Kirby Institute
Sponsor class: OTHER_GOV
First posted: 2012-04-26
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants in MARCH

Brief 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.

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 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.

Primary outcomes:
measure: Mean change in small arterial elasticity (SAE) as measure by pulse wave tonometry
timeFrame: 96 weeks
Secondary outcomes:
measure: • Mean change in large arterial elasticity (LAE) as measure by pulse wave tonometry
timeFrame: 96 weeks
measure: • Changes from baseline in selected soluble markers of immune activation, coagulation, vascular and platelet function
timeFrame: 96 weeks
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital General de Agudos "Dr. José María Ramos Mejía"
city: Buenos Aires
country: Argentina
facility: Fundacion IDEAA
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Sydney
country: Australia
facility: St. Vincent's Hospital
state: New South Wales
city: Frankfurt
country: Germany
facility: Johann Wolfgang Goethe-University Hospital, Medical HIVCENTER
state: Frankfurt am Main
city: Bangkok
country: Thailand
facility: Chulalongkorn University Hospital
Study officials:
affiliation: Kirby Institute
name: Sarah L Pett, FRACP,FRCPE,PhD
role: PRINCIPAL_INVESTIGATOR
References: