Trial | NCT01637259  Report issue

Title

MARCH Renal Substudy
Maraviroc Switch Collaborative Study Renal Substudy

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    76
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).
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 Started
Jun 30
2012
Primary Completion
Dec 31
2015
Study Completion
Dec 31
2015
Last Update
Jan 20
2016
Estimate

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

NRTI + PI Active Comparator

arm 1

PI + maraviroc Active Comparator

arm 2

NRTI + maraviroc Active Comparator

arm 3

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
No Results Posted