MARCH Renal Substudy (MARCHrenal)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Kirby Institute
ClinicalTrials.gov Identifier:
NCT01637259
First received: June 27, 2012
Last updated: July 17, 2014
Last verified: July 2014

June 27, 2012
July 17, 2014
June 2012
January 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01637259 on ClinicalTrials.gov Archive Site
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;
Same as current
Not Provided
Not Provided
 
MARCH Renal Substudy
Maraviroc Switch Collaborative Study Renal Substudy

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
  • Proteinuria
  • HIV
  • 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
  • Active Comparator: NRTI + PI
    arm 1
    Intervention: Drug: arm 1 nucleotide analogue reverse transcriptase inhibitors and boosted protease inhibitors
  • Active Comparator: PI + maraviroc
    arm 2
    Intervention: Drug: Arm 2 boosted protease inhibitors and maraviroc
  • Active Comparator: NRTI + maraviroc
    arm 3
    Intervention: Drug: Arm 3 nucleotide analogue reverse transcriptase inhibitors and maraviroc
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
76
January 2016
January 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Canada,   Germany,   Japan,   Mexico,   Thailand,   United Kingdom
 
NCT01637259
MARCH-Kirby renal
Yes
Kirby Institute
Kirby Institute
Not Provided
Principal Investigator: Waldo Belloso, MD Hospital Italiano de Buenos Aires
Principal Investigator: Mark Kelly, MD Brisbane Sexual Health and HIV Service
Kirby Institute
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP