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MARCH Renal Substudy (MARCHrenal)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01637259
Recruitment Status : Completed
First Posted : July 11, 2012
Last Update Posted : January 20, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Proteinuria HIV 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 Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Maraviroc Switch Collaborative Study Renal Substudy
Study Start Date : June 2012
Primary Completion Date : December 2015
Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Maraviroc
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: NRTI + PI
arm 1
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
Active Comparator: PI + maraviroc
arm 2
Drug: Arm 2 boosted protease inhibitors and maraviroc
PI + maraviroc
Other Names:
  • maraviroc
  • atazanavir
  • lopinavir
  • darunavir
  • fosamprenavir
  • ritonavir
Active Comparator: NRTI + maraviroc
arm 3
Drug: Arm 3 nucleotide analogue reverse transcriptase inhibitors and maraviroc
NRTI + maraviroc
Other Names:
  • maraviroc
  • tenofovir
  • emtricitabine
  • zidovudine
  • abacavir
  • lamivudine


Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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;


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01637259


Locations
Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, Ciudad de Buenos Aires, Argentina, C1181ACH
Hospital General de Agudos J M Ramos Mejia
Buenos Aires, Ciudad de Buenos Aires, Argentina, C1221ADC
Fundación IDEAA
Buenos Aires, Ciudad de Buenos Aires, Argentina, C1405CKC
Australia, New South Wales
St. Vincent's Hospital
Sydney, New South Wales, Australia, 2010
Australia, Queensland
Brisbane Sexual Health and HIV Service
Brisbane, Queensland, Australia, 4000
Canada, Alberta
Southern Alberta Clinic
Calgary, Alberta, Canada, T2R OX7
Canada, Ontario
University Health Network - Toronto General Hospital
Toronto, Ontario, Canada, M5G 2N2
Canada, Quebec
Clinic Opus/Lori
Montreal, Quebec, Canada, H3A 1T1
Germany
Klinikum der Universitat Zu Koln
Cologne, Germany, 50937
Universitätsklinikum Düsseldorf, Klinik für Gastroenterologie, Hepatologie und Infektiologie, MX-Ambulanz
Dusseldorf, Germany, 40225
Japan
Nagoya Medical Center
Nagoya, Japan, 460-0001
Mexico
Instituto Nacional de Ciencias Medicas y Nutriciòn Salvador Zubiran
Mexico City, Tlalpan DF, Mexico, 14000
Thailand
Chulalongkorn University Hospital
Bangkok, Thailand, 10330
United Kingdom
Western General Hospital
Edinburgh, Lothian, United Kingdom
Brighton & Sussex University NHS Trust
Brighton, Sussex, United Kingdom
Sponsors and Collaborators
Kirby Institute
Investigators
Principal Investigator: Waldo Belloso, MD Hospital Italiano de Buenos Aires
Principal Investigator: Mark Kelly, MD Brisbane Sexual Health and HIV Service
More Information

Responsible Party: Kirby Institute
ClinicalTrials.gov Identifier: NCT01637259     History of Changes
Other Study ID Numbers: MARCH-Kirby renal
First Posted: July 11, 2012    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: January 2016

Keywords provided by Kirby Institute:
proteinuria
HIV

Additional relevant MeSH terms:
Proteinuria
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Ritonavir
Lopinavir
Darunavir
Atazanavir Sulfate
HIV Protease Inhibitors
Fosamprenavir
Tenofovir
Lamivudine
Emtricitabine
Zidovudine
Maraviroc
Abacavir
Protease Inhibitors
Reverse Transcriptase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Nucleic Acid Synthesis Inhibitors
Antimetabolites
CCR5 Receptor Antagonists