NCT01637259

MARCH Renal Substudy

Maraviroc Switch Collaborative Study Renal Substudy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Kirby Institute · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Proteinuria
• HIV

Interventions

Type	Name	Description
DRUG	arm 1 nucleotide analogue reverse transcriptase inhibitors and boosted protease inhibitors	NRTI + PI
DRUG	Arm 2 boosted protease inhibitors and maraviroc	PI + maraviroc
DRUG	Arm 3 nucleotide analogue reverse transcriptase inhibitors and maraviroc	NRTI + maraviroc

Timeline

• Start date: 2012-06-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2012-07-11
• Last updated: 2016-01-20

Locations

15 sites across 8 countries: Argentina, Australia, Canada, Germany, Japan, Mexico, Thailand, United Kingdom