Maraviroc Switch Collaborative Study Renal Substudy (MARCHrenal)

NCT01637259 Phase 4 COMPLETED

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).

Details

Lead sponsor	Kirby Institute
Phase	Phase 4
Status	COMPLETED
Enrolment	76
Start date	2012-06
Completion	2015-12

Conditions

• Proteinuria
• HIV

Interventions

• arm 1 nucleotide analogue reverse transcriptase inhibitors and boosted protease inhibitors
• Arm 2 boosted protease inhibitors and maraviroc
• Arm 3 nucleotide analogue reverse transcriptase inhibitors and maraviroc

Primary outcomes

• changes in proteinuria and albuminuria between baseline and week 96 — 96 weeks
  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.

Countries

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