drugset / Trial / NCT01637259

MARCH Renal Substudy

NCT01637259 ↗

Phase 4 Completed 76 enrolled Kirby Institute
RandomizedSingle-groupOpen-label

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).

Timeline

Start
2012-06
Primary completion
2015-12
Completion
2015-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Maraviroc Other / unclassified — —
Comparator Abacavir Other / unclassified — —
Comparator Atazanavir Other / unclassified — —
Comparator Darunavir Small molecule — —
Comparator Fosamprenavir Small molecule — —
Comparator Lamivudine Other / unclassified — —
Comparator Lopinavir Other / unclassified — —
Comparator Ritonavir Other / unclassified — —
Comparator Tenofovir Small molecule — —
Comparator Zidovudine Small molecule — —
Comparator emtricitabine Other / unclassified — —