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NCT Number: NCT01637259

MARCH Renal Substudy

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).

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Key information

Conditions

Proteinuria Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications HIV Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Fundación IDEAA, Buenos Aires, Buenos Aires F.D., Argentina

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

arm 1 nucleotide analogue reverse transcriptase inhibitors and boosted protease inhibitors

Drug

NRTI + PI

Other names: tenofovir, emtricitabine, zidovudine, abacavir, lamivudine, atazanavir, lopinavir, darunavir, fosamprenavir, ritonavir

Arm 2 boosted protease inhibitors and maraviroc

Drug

PI + maraviroc

Other names: maraviroc, atazanavir, lopinavir, darunavir, fosamprenavir, ritonavir

Arm 3 nucleotide analogue reverse transcriptase inhibitors and maraviroc

Drug

NRTI + maraviroc

Other names: maraviroc, tenofovir, emtricitabine, zidovudine, abacavir, lamivudine

Primary outcomes

  1. changes in proteinuria and albuminuria between baseline and week 96

    Time frame: 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 outcomes

  1. changes in renal tubular function between baseline and week 96

    Time frame: 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;

Sponsors and collaborators

Lead sponsor

Kirby Institute

Other Gov

Registry information

Official study title

Maraviroc Switch Collaborative Study Renal Substudy

Acronym: MARCHrenal

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jul 11, 2012
Registry last updated
Jan 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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