MARCH Renal Substudy (MARCHrenal)

This study is currently recruiting participants.

Verified December 2012 by Kirby Institute

Sponsor:

Information provided by (Responsible Party):

Kirby Institute

ClinicalTrials.gov Identifier:

NCT01637259

First received: June 27, 2012

Last updated: December 7, 2012

Last verified: December 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

June 27, 2012

Last Updated Date

December 7, 2012

Start Date ^ICMJE

June 2012

Estimated Primary Completion Date

December 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

changes in proteinuria and albuminuria between baseline and week 96 [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]

To compare the change in protein and albumin excretion as measured by the urine PCR and ACR through the kidneys between the randomised and standard of care (control) arm of MARCH.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01637259 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

changes in renal tubular function between baseline and week 96 [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]

To evaluate the following aspects of renal function at baseline and changes within and between study groups:

Tubular function defined as proximal tubular function; ascending thick loop of Henle; distal tubular function; volume and renal potassium handling;
Non-tubular function i.e. eGFR; Urine albumin:creatinine ratio;
Determine factors associated with renal dysfunction within the cohort e.g. demographics, HIV related, HIV-treatment related, co-morbidities, concomitant medication (such as ACE inhibitors and ARB; PI/r co-administered with TDF); TDF use;

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

MARCH Renal Substudy

Official Title ^ICMJE

Maraviroc Switch Collaborative Study Renal Substudy

Brief Summary

Chronic kidney disease (CKD) is an emerging problem in patients with treated HIV. Antiretroviral therapy associated renal dysfunction has been predominantly described in terms of reduced glomerular filtration (eGFR). Proteinuria is a key component of CKD and may occur in the absence of significant reductions in eGFR. This substudy is an exploration of changes in urinary protein excretion in a randomised, open-label study to evaluate the efficacy and safety of MVC as a switch for either nucleoside or nucleotide analogue reverse transcriptase inhibitors (N(t)RTI) or boosted protease inhibitors (PI/r) in HIV-1 infected individuals with stable, well-controlled plasma HIV-RNA while taking their first N(t)RTI + PI/r regimen of combination antiretroviral therapy (cART).

Detailed Description

The aim of this substudy of MARCH is to characterize the changes in protein and salt excretion through the kidney utilising the randomised arms of the parent study MARCH. The investigators hypothesize there will be an improvement in proteinuria in those switching to maraviroc containing regimens.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label

Condition ^ICMJE

Proteinuria
HIV

Intervention ^ICMJE

Drug: arm 1 nucleotide analogue reverse transcriptase inhibitors and boosted protease inhibitors
NRTI + PI
Other Names:
- tenofovir
- emtricitabine
- zidovudine
- abacavir
- lamivudine
- atazanavir
- lopinavir
- darunavir
- fosamprenavir
- ritonavir
Drug: Arm 2 boosted protease inhibitors and maraviroc
PI + maraviroc
Other Names:
- maraviroc
- atazanavir
- lopinavir
- darunavir
- fosamprenavir
- ritonavir
Drug: Arm 3 nucleotide analogue reverse transcriptase inhibitors and maraviroc
NRTI + maraviroc
Other Names:
- maraviroc
- tenofovir
- emtricitabine
- zidovudine
- abacavir
- lamivudine

Study Arm (s)

Active Comparator: NRTI + PI
arm 1

Intervention: Drug: arm 1 nucleotide analogue reverse transcriptase inhibitors and boosted protease inhibitors
Active Comparator: PI + maraviroc
arm 2

Intervention: Drug: Arm 2 boosted protease inhibitors and maraviroc
Active Comparator: NRTI + maraviroc
arm 3

Intervention: Drug: Arm 3 nucleotide analogue reverse transcriptase inhibitors and maraviroc

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

150

Estimated Completion Date

February 2015

Estimated Primary Completion Date

December 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Provision of written, informed consent for participation in the substudy
Enrolled into the substudy either at or before the week 0 visit of the main study

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: David Silk, BSc	61293850900	dsilk@kirby.unsw.edu.au
Contact: Sarah Pett, FRACP,PhD	61293850900	spett@kirby.unsw.edu.au

Location Countries ^ICMJE

Argentina, Australia, Canada, Chile, France, Germany, Japan, Mexico, Thailand, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT01637259

Other Study ID Numbers ^ICMJE

MARCH-Kirby renal

Has Data Monitoring Committee

Yes

Responsible Party

Kirby Institute

Study Sponsor ^ICMJE

Kirby Institute

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Waldo Belloso, MD	Hospital Italiano de Buenos Aires
Principal Investigator:	Mark Kelly, MD	Brisbane Sexual Health and HIV Service

Information Provided By

Kirby Institute

Verification Date

December 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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