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MARCH Renal Substudy (MARCHrenal)
This study has been completed.
Sponsor:
Kirby Institute
Information provided by (Responsible Party):
Kirby Institute
ClinicalTrials.gov Identifier:
NCT01637259
First received: June 27, 2012
Last updated: January 18, 2016
Last verified: January 2016
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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 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 ]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 ]
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 |
| Study Completion Date: | December 2015 |
| Primary Completion Date: | December 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:
|
|
Active Comparator: PI + maraviroc
arm 2
|
Drug: Arm 2 boosted protease inhibitors and maraviroc
PI + maraviroc
Other Names:
|
|
Active Comparator: NRTI + maraviroc
arm 3
|
Drug: Arm 3 nucleotide analogue reverse transcriptase inhibitors and maraviroc
NRTI + maraviroc
Other Names:
|
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 (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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01637259
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
| Study First Received: | June 27, 2012 |
| Last Updated: | January 18, 2016 |
Keywords provided by Kirby Institute:
|
proteinuria HIV |
Additional relevant MeSH terms:
|
Proteinuria Urination Disorders Urologic Diseases Urological Manifestations Signs and Symptoms Ritonavir HIV Protease Inhibitors Lopinavir Darunavir Atazanavir Sulfate Fosamprenavir Tenofovir Zidovudine Emtricitabine Lamivudine |
Abacavir Maraviroc 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 |
ClinicalTrials.gov processed this record on June 26, 2017