MARCH Renal Substudy

NCT01637259 — Phase 4, Completed, 76 participants, Kirby Institute

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Maraviroc Switch Collaborative Study Renal Substudy

Registry	NCT01637259, acronym MARCHrenal
Status	Completed
Phase	Phase 4
Study type	Interventional; randomized, single group, masking: none
Enrollment	76 (Actual)
Sponsor	Kirby Institute (Other gov)
Conditions	Proteinuria, HIV
Interventions	arm 1 nucleotide analogue reverse transcriptase inhibitors and boosted protease inhibitors, Arm 2 boosted protease inhibitors and maraviroc, Arm 3 nucleotide analogue reverse transcriptase inhibitors and maraviroc (Drug)
Dates	start 2012-06-01, primary completion 2015-12-01, completion 2015-12-01, first posted 2012-07-11, last updated 2016-01-20
Locations	15 sites in Argentina, Australia, Canada, Germany, Japan, Mexico, Thailand, United Kingdom

-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).

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
NRTI + PI	Active comparator	Drug: arm 1 nucleotide analogue reverse transcriptase inhibitors and boosted protease inhibitors	arm 1
PI + maraviroc	Active comparator	Drug: Arm 2 boosted protease inhibitors and maraviroc	arm 2
NRTI + maraviroc	Active comparator	Drug: Arm 3 nucleotide analogue reverse transcriptase inhibitors and maraviroc	arm 3

arm 1 nucleotide analogue reverse transcriptase inhibitors and boosted protease inhibitors (Drug), also known as tenofovir, emtricitabine, zidovudine, abacavir, lamivudine, atazanavir, lopinavir, darunavir, fosamprenavir, ritonavir: NRTI + PI
Arm 2 boosted protease inhibitors and maraviroc (Drug), also known as maraviroc, atazanavir, lopinavir, darunavir, fosamprenavir, ritonavir: PI + maraviroc
Arm 3 nucleotide analogue reverse transcriptase inhibitors and maraviroc (Drug), also known as maraviroc, tenofovir, emtricitabine, zidovudine, abacavir, lamivudine: NRTI + maraviroc

+Outcome measures

Primary outcomes

changes in proteinuria and albuminuria between baseline and week 96 [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 outcomes

changes in renal tubular function between baseline and week 96 [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

Sex: All, ages: 18 Years to any

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

+Locations (15)

Facility	City	Country
Hospital Italiano de Buenos Aires	Buenos Aires, Buenos Aires F.D.	Argentina
Hospital General de Agudos J M Ramos Mejia	Buenos Aires, Buenos Aires F.D.	Argentina
Fundación IDEAA	Buenos Aires, Buenos Aires F.D.	Argentina
St. Vincent's Hospital	Sydney, New South Wales	Australia
Brisbane Sexual Health and HIV Service	Brisbane, Queensland	Australia
Southern Alberta Clinic	Calgary, Alberta	Canada
University Health Network - Toronto General Hospital	Toronto, Ontario	Canada
Clinic Opus/Lori	Montreal, Quebec	Canada
Klinikum der Universitat Zu Koln	Cologne	Germany
Universitätsklinikum Düsseldorf, Klinik für Gastroenterologie, Hepatologie und Infektiologie, MX-Ambulanz	Düsseldorf	Germany
Nagoya Medical Center	Nagoya	Japan
Instituto Nacional de Ciencias Medicas y Nutriciòn Salvador Zubiran	Mexico City, Tlalpan DF	Mexico
Chulalongkorn University Hospital	Bangkok	Thailand
Western General Hospital	Edinburgh, Lothian	United Kingdom
Brighton & Sussex University NHS Trust	Brighton, Sussex	United Kingdom

+Investigators

Waldo Belloso, MD, Principal investigator, Hospital Italiano de Buenos Aires
Mark Kelly, MD, Principal investigator, Brisbane Sexual Health and HIV Service