MARCH Renal Substudy

Phase 4

Completed

• Conditions: HIV; Proteinuria
• Interventions: Drug: arm 1 nucleotide analogue reverse transcriptase inhibitors and boosted protease inhibitors; Drug: Arm 3 nucleotide analogue reverse transcriptase inhibitors and maraviroc; Drug: Arm 2 boosted protease inhibitors and maraviroc

• Registration Number: NCT01637259
• Lead Sponsor: Kirby Institute

Brief 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).

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.

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-27
• Study First Submitted QC: 2012-07-10
• Study First Posted: 2012-07-11
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-18
• Last Update Posted: 2016-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NRTI + PI	arm 1 nucleotide analogue reverse transcriptase inhibitors and boosted protease inhibitors	arm 1
NRTI + maraviroc	Arm 3 nucleotide analogue reverse transcriptase inhibitors and maraviroc	arm 3
PI + maraviroc	Arm 2 boosted protease inhibitors and maraviroc	arm 2

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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;

Trial Locations

Locations (15)

Brighton & Sussex University NHS Trust; 🇬🇧 Brighton, Sussex, United Kingdom

Brisbane Sexual Health and HIV Service; 🇦🇺 Brisbane, Queensland, Australia

Universitätsklinikum Düsseldorf, Klinik für Gastroenterologie, Hepatologie und Infektiologie, MX-Ambulanz; 🇩🇪 Dusseldorf, Germany

Klinikum der Universitat Zu Koln; 🇩🇪 Cologne, Germany

St. Vincent's Hospital; 🇦🇺 Sydney, New South Wales, Australia

University Health Network - Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada

Southern Alberta Clinic; 🇨🇦 Calgary, Alberta, Canada

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

Clinic Opus/Lori; 🇨🇦 Montreal, Quebec, Canada

Hospital Italiano de Buenos Aires; 🇦🇷 Buenos Aires, Ciudad de Buenos Aires, Argentina

Hospital General de Agudos J M Ramos Mejia; 🇦🇷 Buenos Aires, Ciudad de Buenos Aires, Argentina

Nagoya Medical Center; 🇯🇵 Nagoya, Japan

Fundación IDEAA; 🇦🇷 Buenos Aires, Ciudad de Buenos Aires, Argentina