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

Purpose

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).

Condition	Intervention	Phase
Proteinuria HIV	Drug: arm 1 nucleotide analogue reverse transcriptase inhibitors and boosted protease inhibitors Drug: Arm 2 boosted protease inhibitors and maraviroc Drug: Arm 3 nucleotide analogue reverse transcriptase inhibitors and maraviroc	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label
Official Title:	Maraviroc Switch Collaborative Study Renal Substudy

Resource links provided by NLM:

Further study details as provided by Kirby Institute:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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;

Estimated Enrollment:	150
Study Start Date:	June 2012
Estimated Study Completion Date:	February 2015
Estimated Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01637259

Contacts

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

Show 24 Study Locations

Sponsors and Collaborators

Kirby Institute

Investigators

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

More Information

No publications provided

Responsible Party:	Kirby Institute
ClinicalTrials.gov Identifier:	NCT01637259 History of Changes
Other Study ID Numbers:	MARCH-Kirby renal
Study First Received:	June 27, 2012
Last Updated:	December 7, 2012
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration Thailand: Ministry of Public Health

Keywords provided by Kirby Institute:

proteinuria
HIV

Additional relevant MeSH terms:

Proteinuria
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Protease Inhibitors
Ritonavir
Lopinavir
Atazanavir
Fosamprenavir
Darunavir
Zidovudine
Lamivudine
Reverse Transcriptase Inhibitors

Tenofovir
Abacavir
Emtricitabine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites
Nucleic Acid Synthesis Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents
HIV Protease Inhibitors

ClinicalTrials.gov processed this record on March 10, 2013

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