NCT01585753

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2012

Typical duration for all trials

Geographic Reach
4 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 26, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 20, 2016

Status Verified

January 1, 2016

Enrollment Period

3.5 years

First QC Date

April 25, 2012

Last Update Submit

January 18, 2016

Conditions

Cardiovascular Disease

Keywords

cardiovascular functionmaraviroc

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

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

    96 weeks

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

    96 weeks

Study Arms (3)

Arm 1

NRTI and PI

Drug: NRTI + PI

Arm 2

Maraviroc + PI

Drug: maraviroc + PI

Arm 3

maraviroc + NRTI

Drug: maraviroc + NRTI

Interventions

NRTI + PIDRUG

tenofovir zidovudine abacavir lamivudine emtricitabine ritonavir darunavir atazanavir lopinavir fosamprenavir

Arm 1
maraviroc + PIDRUG

maraviroc ritonavir darunavir atazanavir lopinavir fosamprenavir

Arm 2
maraviroc + NRTIDRUG

maraviroc tenofovir zidovudine abacavir lamivudine emtricitabine

Arm 3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Participants in MARCH

You may qualify if:

  • Enrolled prior to treatment in the parent study;
  • Provision of written, informed consent for participation in the substudy

You may not qualify if:

  • Known supraventricular tachycardia such as atrial flutter and/or fibrillation that precludes the measurement of pulse wave using tonometry.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Hospital General de Agudos "Dr. José María Ramos Mejía"

Buenos Aires, Buenos Aires, C1221ADC, Argentina

Location

Fundacion IDEAA

Buenos Aires, Buenos Aires, C1405CKC, Argentina

Location

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

Location

St. Vincent's Hospital

Sydney, New South Wales, 2010, Australia

Location

Johann Wolfgang Goethe-University Hospital, Medical HIVCENTER

Frankfurt, Frankfurt Am Main, 60590, Germany

Location

Chulalongkorn University Hospital

Bangkok, Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Maraviroc

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Sarah L Pett, FRACP,FRCPE,PhD

    Kirby Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2012

First Posted

April 26, 2012

Study Start

June 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 20, 2016

Record last verified: 2016-01

Locations

TH(1)AU(1)AR(3)DE(1)