Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01637259




Registration number
NCT01637259
Ethics application status
Date submitted
27/06/2012
Date registered
11/07/2012
Date last updated
20/01/2016

Titles & IDs
Public title
MARCH Renal Substudy
Scientific title
Maraviroc Switch Collaborative Study Renal Substudy
Secondary ID [1] 0 0
MARCH-Kirby renal
Universal Trial Number (UTN)
Trial acronym
MARCHrenal
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Proteinuria 0 0
HIV 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - arm 1 nucleotide analogue reverse transcriptase inhibitors and boosted protease inhibitors
Treatment: Drugs - Arm 2 boosted protease inhibitors and maraviroc
Treatment: Drugs - Arm 3 nucleotide analogue reverse transcriptase inhibitors and maraviroc

Active Comparator: NRTI + PI - arm 1

Active Comparator: PI + maraviroc - arm 2

Active Comparator: NRTI + maraviroc - arm 3


Treatment: Drugs: arm 1 nucleotide analogue reverse transcriptase inhibitors and boosted protease inhibitors
NRTI + PI

Treatment: Drugs: Arm 2 boosted protease inhibitors and maraviroc
PI + maraviroc

Treatment: Drugs: Arm 3 nucleotide analogue reverse transcriptase inhibitors and maraviroc
NRTI + maraviroc
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
changes in proteinuria and albuminuria between baseline and week 96
Timepoint [1] 0 0
96 weeks
Secondary outcome [1] 0 0
changes in renal tubular function between baseline and week 96
Timepoint [1] 0 0
96 weeks

Eligibility
Key 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 age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2015
Sample size
Target
Accrual to date
Final
76
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
St. Vincent's Hospital - Sydney
Recruitment hospital [2] 0 0
Brisbane Sexual Health and HIV Service - Brisbane
Recruitment postcode(s) [1] 0 0
2010 - Sydney
Recruitment postcode(s) [2] 0 0
4000 - Brisbane
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Ciudad de Buenos Aires
Country [2] 0 0
Canada
State/province [2] 0 0
Alberta
Country [3] 0 0
Canada
State/province [3] 0 0
Ontario
Country [4] 0 0
Canada
State/province [4] 0 0
Quebec
Country [5] 0 0
Germany
State/province [5] 0 0
Cologne
Country [6] 0 0
Germany
State/province [6] 0 0
Dusseldorf
Country [7] 0 0
Japan
State/province [7] 0 0
Nagoya
Country [8] 0 0
Mexico
State/province [8] 0 0
Tlalpan DF
Country [9] 0 0
Thailand
State/province [9] 0 0
Bangkok
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Lothian
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Sussex

Funding & Sponsors
Primary sponsor type
Other
Name
Kirby Institute
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT01637259
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Waldo Belloso, MD
Address 0 0
Hospital Italiano de Buenos Aires
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01637259