Cardiovascular DiseaseMARCH VENCT01585753
MARCH Vascular Endothelium Substudy
An observational study of Cardiovascular Disease, run by Kirby Institute at 6 sites in 4 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- NRTI + PI, maraviroc + PI and maraviroc + NRTI
- How many people
- 34 participants
- Where
- 6 sitesin 4 countries
- Study dates
- Jun 2012to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants in MARCH
Who may be able to join
- Enrolled prior to treatment in the parent study;
- Provision of written, informed consent for participation in the substudy
Who cannot join
- Known supraventricular tachycardia such as atrial flutter and/or fibrillation that precludes the measurement of pulse wave using tonometry.
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Argentina3 sites
Hospital General de Agudos "Dr. José María Ramos Mejía"
Buenos Aires, Buenos Aires, C1221ADC
Fundacion IDEAA
Buenos Aires, Buenos Aires, C1405CKC
Hospital Italiano de Buenos Aires
Buenos Aires
Germany1 site
Johann Wolfgang Goethe-University Hospital, Medical HIVCENTER
Frankfurt, Frankfurt Am Main, 60590
About this study
Official title: Maraviroc Switch Vascular Endothelium (VE) Substudy: a Substudy of MARCH
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.
Read the 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.
- Conditions
- Cardiovascular Disease
- Being tested
- NRTI + PI, maraviroc + PI, maraviroc + NRTI
- Keywords
- cardiovascular function, maraviroc
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NRTI + PIDrug
tenofovir zidovudine abacavir lamivudine emtricitabine ritonavir darunavir atazanavir lopinavir fosamprenavir
maraviroc + PIDrug
maraviroc ritonavir darunavir atazanavir lopinavir fosamprenavir
maraviroc + NRTIDrug
maraviroc tenofovir zidovudine abacavir lamivudine emtricitabine
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | NRTI and PI Receives: Drug: NRTI + PI | |
| Arm 2 | Maraviroc + PI Receives: Drug: maraviroc + PI | |
| Arm 3 | maraviroc + NRTI Receives: Drug: maraviroc + NRTI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in small arterial elasticity (SAE) as measure by pulse wave tonometry
measured at 6 timepoints week 0, 4, 12, 24, 48, 96
Measured: 96 weeks
Secondary outcomes (2)
• Mean change in large arterial elasticity (LAE) as measure by pulse wave tonometry
measured at 6 timepoints, week 0,4,12,24,48,96
Measured: 96 weeks
• 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
Measured: 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirby Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Sarah L Pett, FRACP,FRCPE,PhD, Principal investigator, Kirby Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01585753
- Sponsor's protocol ID
- MARCH-Kirby VE substudy
- Acronym
- MARCH VE
- Status last verified
- Jan 2016
- First submitted
- 25 Apr 2012
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maraviroc Switch Vascular Endothelium (VE) Substudy: a Substudy of MARCH
- ClinicalTrials.gov ID
- NCT01585753
- Acronym / sponsor ID
- MARCH VE / MARCH-Kirby VE substudy
- Conditions
- Cardiovascular Disease
- Keywords
- cardiovascular function, maraviroc
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Kirby InstituteOther government
- Study start
- Jun 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 26 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | – | Drug: NRTI + PINRTI and PI |
| Arm 2 | – | Drug: maraviroc + PIMaraviroc + PI |
| Arm 3 | – | Drug: maraviroc + NRTImaraviroc + NRTI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants in MARCH
Key inclusion criteria (2 listed)
- Enrolled prior to treatment in the parent study;
- Provision of written, informed consent for participation in the substudy
Key exclusion criteria (1 listed)
- Known supraventricular tachycardia such as atrial flutter and/or fibrillation that precludes the measurement of pulse wave using tonometry.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NRTI + PItenofovir zidovudine abacavir lamivudine emtricitabine ritonavir darunavir atazanavir lopinavir fosamprenavir | Drug | Arm 1 |
| maraviroc + PImaraviroc ritonavir darunavir atazanavir lopinavir fosamprenavir | Drug | Arm 2 |
| maraviroc + NRTImaraviroc tenofovir zidovudine abacavir lamivudine emtricitabine | Drug | Arm 3 |
Primary outcome
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
2 secondary outcomes
• Mean change in large arterial elasticity (LAE) as measure by pulse wave tonometry
Time frame: 96 weeks
• Changes from baseline in selected soluble markers of immune activation, coagulation, vascular and platelet function
Time frame: 96 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah L Pett, FRACP,FRCPE,PhD principal investigator
Kirby Institute
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Disease, run by Kirby Institute at 6 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Argentina, Australia, Germany, Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in small arterial elasticity (SAE) as measure by pulse wave tonometry (time frame: 96 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2016.