MARCH Renal Substudy (MARCHrenal)
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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 |
- 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.
- 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;
Estimated Enrollment: | 150 |
Study Start Date: | June 2012 |
Estimated Study Completion Date: | February 2015 |
Estimated Primary Completion Date: | December 2014 (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.
![](https://webarchive.library.unt.edu/web/20130312001044im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
![](https://webarchive.library.unt.edu/web/20130312001044im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Contact: David Silk, BSc | 61293850900 | dsilk@kirby.unsw.edu.au |
Contact: Sarah Pett, FRACP,PhD | 61293850900 | spett@kirby.unsw.edu.au |
![](https://webarchive.library.unt.edu/web/20130312001044im_/http://clinicaltrials.gov/ct2/html/images/frame/plus.gif)
Principal Investigator: | Waldo Belloso, MD | Hospital Italiano de Buenos Aires |
Principal Investigator: | Mark Kelly, MD | Brisbane Sexual Health and HIV Service |
![](https://webarchive.library.unt.edu/web/20130312001044im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
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: | December 7, 2012 |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration Thailand: Ministry of Public Health |
Keywords provided by Kirby Institute:
proteinuria HIV |
Additional relevant MeSH terms:
Proteinuria Urination Disorders Urologic Diseases Urological Manifestations Signs and Symptoms Protease Inhibitors Ritonavir Lopinavir Atazanavir Fosamprenavir Darunavir Zidovudine Lamivudine Reverse Transcriptase Inhibitors |
Tenofovir Abacavir Emtricitabine Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites Nucleic Acid Synthesis Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents HIV Protease Inhibitors |
ClinicalTrials.gov processed this record on March 10, 2013