MARCH Renal Substudy

Overview

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).

Full Title of Study: “Maraviroc Switch Collaborative Study Renal Substudy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2015

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • Active Comparator: NRTI + PI
    • arm 1
  • Active Comparator: PI + maraviroc
    • arm 2
  • Active Comparator: NRTI + maraviroc
    • arm 3

Clinical Trial Outcome Measures

Primary Measures

  • changes in proteinuria and albuminuria between baseline and week 96
    • Time Frame: 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.

Secondary Measures

  • changes in renal tubular function between baseline and week 96
    • Time Frame: 96 weeks
    • 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;

Participating in This Clinical Trial

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 Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Kirby Institute
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Waldo Belloso, MD, Principal Investigator, Hospital Italiano de Buenos Aires
    • Mark Kelly, MD, Principal Investigator, Brisbane Sexual Health and HIV Service

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