MARCH Renal Substudy (MARCHrenal)

Kirby Institute

Status and phase

Completed

Phase 4

Conditions

Proteinuria

HIV

Treatments

Drug: arm 1 nucleotide analogue reverse transcriptase inhibitors and boosted protease inhibitors

Drug: Arm 2 boosted protease inhibitors and maraviroc

Drug: Arm 3 nucleotide analogue reverse transcriptase inhibitors and maraviroc

Study type

Interventional

Funder types

Other

Identifiers

NCT01637259

MARCH-Kirby renal

Details and patient eligibility

About

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).

Full 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.

Enrollment

76 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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