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MARCH Renal Substudy

NCT01637259 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2016-01-20

No results posted yet for this study

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).

Conditions

  • Proteinuria
  • HIV

Interventions

DRUG

arm 1 nucleotide analogue reverse transcriptase inhibitors and boosted protease inhibitors

NRTI + PI

DRUG

Arm 2 boosted protease inhibitors and maraviroc

PI + maraviroc

DRUG

Arm 3 nucleotide analogue reverse transcriptase inhibitors and maraviroc

NRTI + maraviroc

Sponsors & Collaborators

  • Kirby Institute

    lead OTHER_GOV

Principal Investigators

  • Waldo Belloso, MD · Hospital Italiano de Buenos Aires

  • Mark Kelly, MD · Brisbane Sexual Health and HIV Service

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

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

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01637259 on ClinicalTrials.gov