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Completed

NCT Number: NCT01585753

MARCH Vascular Endothelium Substudy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fundacion IDEAA, Buenos Aires, Argentina

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NRTI + PI

Drug

tenofovir zidovudine abacavir lamivudine emtricitabine ritonavir darunavir atazanavir lopinavir fosamprenavir

maraviroc + PI

Drug

maraviroc ritonavir darunavir atazanavir lopinavir fosamprenavir

maraviroc + NRTI

Drug

maraviroc tenofovir zidovudine abacavir lamivudine emtricitabine

Primary outcomes

  1. Mean change in small arterial elasticity (SAE) as measure by pulse wave tonometry

    Time frame: 96 weeks

    measured at 6 timepoints week 0, 4, 12, 24, 48, 96

Secondary outcomes

  1. • Mean change in large arterial elasticity (LAE) as measure by pulse wave tonometry

    Time frame: 96 weeks

    measured at 6 timepoints, week 0,4,12,24,48,96

  2. • Changes from baseline in selected soluble markers of immune activation, coagulation, vascular and platelet function

    Time frame: 96 weeks

    stored bloods from the main study will be used to explore changes in vascular biomarkers

Sponsors and collaborators

Lead sponsor

Kirby Institute

Other Gov

Registry information

Official study title

Maraviroc Switch Vascular Endothelium (VE) Substudy: a Substudy of MARCH

Acronym: MARCH VE

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Apr 26, 2012
Registry last updated
Jan 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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