MARCH Renal Substudy

NCT ID: NCT01637259

Last Updated: 2016-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2015-12-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Proteinuria HIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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NRTI + PI

arm 1

Group Type ACTIVE_COMPARATOR

arm 1 nucleotide analogue reverse transcriptase inhibitors and boosted protease inhibitors

Intervention Type DRUG

NRTI + PI

PI + maraviroc

arm 2

Group Type ACTIVE_COMPARATOR

Arm 2 boosted protease inhibitors and maraviroc

Intervention Type DRUG

PI + maraviroc

NRTI + maraviroc

arm 3

Group Type ACTIVE_COMPARATOR

Arm 3 nucleotide analogue reverse transcriptase inhibitors and maraviroc

Intervention Type DRUG

NRTI + maraviroc

Interventions

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arm 1 nucleotide analogue reverse transcriptase inhibitors and boosted protease inhibitors

NRTI + PI

Intervention Type DRUG

Arm 2 boosted protease inhibitors and maraviroc

PI + maraviroc

Intervention Type DRUG

Arm 3 nucleotide analogue reverse transcriptase inhibitors and maraviroc

NRTI + maraviroc

Intervention Type DRUG

Other Intervention Names

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tenofovir emtricitabine zidovudine abacavir lamivudine atazanavir lopinavir darunavir fosamprenavir ritonavir maraviroc atazanavir lopinavir darunavir fosamprenavir ritonavir maraviroc tenofovir emtricitabine zidovudine abacavir lamivudine

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kirby Institute

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Waldo Belloso, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Italiano de Buenos Aires

Mark Kelly, MD

Role: PRINCIPAL_INVESTIGATOR

Brisbane Sexual Health and HIV Service

Locations

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Hospital Italiano de Buenos Aires

Buenos Aires, Buenos Aires F.D., Argentina

Site Status

Hospital General de Agudos J M Ramos Mejia

Buenos Aires, Buenos Aires F.D., Argentina

Site Status

Fundación IDEAA

Buenos Aires, Buenos Aires F.D., Argentina

Site Status

St. Vincent's Hospital

Sydney, New South Wales, Australia

Site Status

Brisbane Sexual Health and HIV Service

Brisbane, Queensland, Australia

Site Status

Southern Alberta Clinic

Calgary, Alberta, Canada

Site Status

University Health Network - Toronto General Hospital

Toronto, Ontario, Canada

Site Status

Clinic Opus/Lori

Montreal, Quebec, Canada

Site Status

Klinikum der Universitat Zu Koln

Cologne, , Germany

Site Status

Universitätsklinikum Düsseldorf, Klinik für Gastroenterologie, Hepatologie und Infektiologie, MX-Ambulanz

Düsseldorf, , Germany

Site Status

Nagoya Medical Center

Nagoya, , Japan

Site Status

Instituto Nacional de Ciencias Medicas y Nutriciòn Salvador Zubiran

Mexico City, Tlalpan DF, Mexico

Site Status

Chulalongkorn University Hospital

Bangkok, , Thailand

Site Status

Western General Hospital

Edinburgh, Lothian, United Kingdom

Site Status

Brighton & Sussex University NHS Trust

Brighton, Sussex, United Kingdom

Site Status

Countries

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Argentina Australia Canada Germany Japan Mexico Thailand United Kingdom

Other Identifiers

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MARCH-Kirby renal

Identifier Type: -

Identifier Source: org_study_id

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