MARCH Vascular Endothelium Substudy

Cardiovascular Disease Clinical Trial

— MARCH VE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01585753
• Other study ID #: MARCH-Kirby VE substudy
• Status: Completed
• Phase: N/A
• First received: April 25, 2012
• Last updated: January 18, 2016
• Start date: June 2012
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Kirby Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaGermany: Ministry of HealthThailand: Ministry of Public Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Drug:
• NRTI + PI
tenofovir zidovudine abacavir lamivudine emtricitabine ritonavir darunavir atazanavir lopinavir fosamprenavir
• maraviroc + PI
maraviroc ritonavir darunavir atazanavir lopinavir fosamprenavir
• maraviroc + NRTI
maraviroc tenofovir zidovudine abacavir lamivudine emtricitabine

Locations

Country	Name	City	State
Argentina	Fundacion IDEAA	Buenos Aires
Argentina	Hospital General de Agudos "Dr. José María Ramos Mejía"	Buenos Aires
Argentina	Hospital Italiano de Buenos Aires	Buenos Aires
Australia	St. Vincent's Hospital	Sydney	New South Wales
Germany	Johann Wolfgang Goethe-University Hospital, Medical HIVCENTER	Frankfurt	Frankfurt am Main
Thailand	Chulalongkorn University Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Kirby Institute

Countries where clinical trial is conducted

Argentina,  Australia,  Germany,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	• 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	No
Secondary	• Changes from baseline in selected soluble markers of immune activation, coagulation, vascular and platelet function	stored bloods from the main study will be used to explore changes in vascular biomarkers	96 weeks	No