MARCH Renal Substudy

HIV Clinical Trial

— MARCHrenal  

Official title:

Maraviroc Switch Collaborative Study Renal Substudy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01637259
• Other study ID #: MARCH-Kirby renal
• Status: Completed
• Phase: Phase 4
• First received: June 27, 2012
• Last updated: January 18, 2016
• Start date: June 2012
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Kirby Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationThailand: Ministry of Public HealthArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaJapan: Ministry of Health, Labor and WelfareCanada: Health CanadaMexico: Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• HIV
• Proteinuria

Intervention

Drug:
• arm 1 nucleotide analogue reverse transcriptase inhibitors and boosted protease inhibitors
NRTI + PI
• Arm 2 boosted protease inhibitors and maraviroc
PI + maraviroc
• Arm 3 nucleotide analogue reverse transcriptase inhibitors and maraviroc
NRTI + maraviroc

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Kirby Institute

Countries where clinical trial is conducted

Argentina,  Australia,  Canada,  Germany,  Japan,  Mexico,  Thailand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in proteinuria and albuminuria between baseline and week 96	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.	96 weeks	No
Secondary	changes in renal tubular function between baseline and week 96	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;	96 weeks	No