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
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Maraviroc Switch Collaborative Study Renal Substudy

Resource links provided by NLM:


Further study details as provided by Kirby Institute:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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;


Enrollment: 76
Study Start Date: June 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01637259

Locations
Argentina
Fundación IDEAA
Buenos Aires, Ciudad de Buenos Aires, Argentina, C1405CKC
Hospital General de Agudos J M Ramos Mejia
Buenos Aires, Ciudad de Buenos Aires, Argentina, C1221ADC
Hospital Italiano de Buenos Aires
Buenos Aires, Ciudad de Buenos Aires, Argentina, C1181ACH
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

No publications provided

Responsible Party: Kirby Institute
ClinicalTrials.gov Identifier: NCT01637259     History of Changes
Other Study ID Numbers: MARCH-Kirby renal
Study First Received: June 27, 2012
Last Updated: July 17, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Thailand: Ministry of Public Health
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Japan: Ministry of Health, Labor and Welfare
Canada: Health Canada
Mexico: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Kirby Institute:
proteinuria
HIV

Additional relevant MeSH terms:
Proteinuria
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations
Abacavir
Atazanavir
Darunavir
Emtricitabine
Fosamprenavir
HIV Protease Inhibitors
Lamivudine
Lopinavir
Protease Inhibitors
Reverse Transcriptase Inhibitors
Ritonavir
Tenofovir
Zidovudine
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antimetabolites
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014