Clinical trial NCT01637259: MARCH Renal Substudy
Official title: Maraviroc Switch Collaborative Study Renal Substudy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Proteinuria
HIV
Keywords: proteinuria
HIV
Lead sponsor: Kirby Institute
Sponsor class: OTHER_GOV
First posted: 2012-07-11
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

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.

Eligibility criteria: 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

Primary outcomes:
measure: changes in proteinuria and albuminuria between baseline and week 96
timeFrame: 96 weeks
Secondary outcomes:
measure: changes in renal tubular function between baseline and week 96
timeFrame: 96 weeks
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
state: Ciudad de Buenos Aires
city: Buenos Aires
country: Argentina
facility: Hospital General de Agudos J M Ramos Mejia
state: Ciudad de Buenos Aires
city: Buenos Aires
country: Argentina
facility: Fundación IDEAA
state: Ciudad de Buenos Aires
city: Sydney
country: Australia
facility: St. Vincent's Hospital
state: New South Wales
city: Brisbane
country: Australia
facility: Brisbane Sexual Health and HIV Service
state: Queensland
city: Calgary
country: Canada
facility: Southern Alberta Clinic
state: Alberta
city: Toronto
country: Canada
facility: University Health Network - Toronto General Hospital
state: Ontario
city: Montreal
country: Canada
facility: Clinic Opus/Lori
state: Quebec
city: Cologne
country: Germany
facility: Klinikum der Universitat Zu Koln
city: Dusseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf, Klinik für Gastroenterologie, Hepatologie und Infektiologie, MX-Ambulanz
city: Nagoya
country: Japan
facility: Nagoya Medical Center
city: Mexico City
country: Mexico
facility: Instituto Nacional de Ciencias Medicas y Nutriciòn Salvador Zubiran
state: Tlalpan DF
city: Bangkok
country: Thailand
facility: Chulalongkorn University Hospital
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
state: Lothian
city: Brighton
country: United Kingdom
facility: Brighton & Sussex University NHS Trust
state: Sussex
Study officials:
affiliation: Hospital Italiano de Buenos Aires
name: Waldo Belloso, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brisbane Sexual Health and HIV Service
name: Mark Kelly, MD
role: PRINCIPAL_INVESTIGATOR
References: