Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00006498

Trial Description

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Title

Maraviroc Switch Collaborative Study Renal Substudy

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Trial Acronym

MARCHrenal

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URL of the Trial

[---]*

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Brief Summary in Lay Language

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).

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Brief Summary in Scientific Language

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.

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Organizational Data

  •   DRKS00006498
  •   2015/01/22
  •   2012/06/27
  •   yes
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Secondary IDs

  •   NCT01637259  (ClinicalTrials.gov)
  •   MARCH-Kirby renal  (Kirby Institute)
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Health Condition or Problem studied

  •   Proteinuria
  •   HIV
  •   B24 -  Unspecified human immunodeficiency virus [HIV] disease
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Interventions/Observational Groups

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

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control
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  •   Single (group)
  •   IV
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Primary Outcome

- 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.

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Secondary Outcome

- 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;

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Countries of Recruitment

  •   Argentina
  •   Australia
  •   Canada
  •   Germany
  •   Japan
  •   Mexico
  •   Thailand
  •   United Kingdom
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Locations of Recruitment

  •  
  •  
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Recruitment

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  •   2012/06/30
  •   75
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion 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

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Exclusion Criteria

[---]*

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Addresses

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    • Kirby Institute
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    • Hospital Italiano de Buenos Aires
    • Waldo Belloso, MD 
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    • Hospital Italiano de Buenos Aires
    • Waldo Belloso, MD 
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2014/07/16
* This entry means the parameter is not applicable or has not been set.