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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01585753




Registration number
NCT01585753
Ethics application status
Date submitted
25/04/2012
Date registered
26/04/2012
Date last updated
20/01/2016

Titles & IDs
Public title
MARCH Vascular Endothelium Substudy
Scientific title
Maraviroc Switch Vascular Endothelium (VE) Substudy: a Substudy of MARCH
Secondary ID [1] 0 0
MARCH-Kirby VE substudy
Universal Trial Number (UTN)
Trial acronym
MARCH VE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Disease 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - NRTI + PI
Treatment: Drugs - maraviroc + PI
Treatment: Drugs - maraviroc + NRTI

Arm 1 - NRTI and PI

Arm 2 - Maraviroc + PI

Arm 3 - maraviroc + NRTI


Treatment: Drugs: NRTI + PI
tenofovir zidovudine abacavir lamivudine emtricitabine ritonavir darunavir atazanavir lopinavir fosamprenavir

Treatment: Drugs: maraviroc + PI
maraviroc ritonavir darunavir atazanavir lopinavir fosamprenavir

Treatment: Drugs: maraviroc + NRTI
maraviroc tenofovir zidovudine abacavir lamivudine emtricitabine
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean change in small arterial elasticity (SAE) as measure by pulse wave tonometry
Timepoint [1] 0 0
96 weeks
Secondary outcome [1] 0 0
• Mean change in large arterial elasticity (LAE) as measure by pulse wave tonometry
Timepoint [1] 0 0
96 weeks
Secondary outcome [2] 0 0
• Changes from baseline in selected soluble markers of immune activation, coagulation, vascular and platelet function
Timepoint [2] 0 0
96 weeks

Eligibility
Key inclusion criteria
- Enrolled prior to treatment in the parent study;

- Provision of written, informed consent for participation in the substudy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Known supraventricular tachycardia such as atrial flutter and/or fibrillation that
precludes the measurement of pulse wave using tonometry.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2015
Sample size
Target
Accrual to date
Final
34
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
St. Vincent's Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2010 - Sydney
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Germany
State/province [2] 0 0
Frankfurt am Main
Country [3] 0 0
Thailand
State/province [3] 0 0
Bangkok

Funding & Sponsors
Primary sponsor type
Other
Name
Kirby Institute
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT01585753
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sarah L Pett, FRACP,FRCPE,PhD
Address 0 0
Kirby Institute, UNSW
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01585753