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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NRTI + PI | Active Comparator | arm 1 |
|
| PI + maraviroc | Active Comparator | arm 2 |
|
| NRTI + maraviroc | Active Comparator | arm 3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| arm 1 nucleotide analogue reverse transcriptase inhibitors and boosted protease inhibitors | Drug | NRTI + PI |
|
| Measure | Description | Time Frame |
|---|---|---|
| changes in proteinuria and albuminuria between baseline and week 96 | 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. | 96 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| changes in renal tubular function between baseline and week 96 | To evaluate the following aspects of renal function at baseline and changes within and between study groups:
|
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Waldo Belloso, MD | Hospital Italiano de Buenos Aires | Principal Investigator |
| Mark Kelly, MD | Brisbane Sexual Health and HIV Service | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Italiano de Buenos Aires | Buenos Aires | Buenos Aires F.D. | C1181ACH | Argentina | ||
| Hospital General de Agudos J M Ramos Mejia |
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| Arm 2 boosted protease inhibitors and maraviroc | Drug | PI + maraviroc |
|
|
| Arm 3 nucleotide analogue reverse transcriptase inhibitors and maraviroc | Drug | NRTI + maraviroc |
|
|
| 96 weeks |
| Buenos Aires |
| Buenos Aires F.D. |
| C1221ADC |
| Argentina |
| Fundación IDEAA | Buenos Aires | Buenos Aires F.D. | C1405CKC | Argentina |
| St. Vincent's Hospital | Sydney | New South Wales | 2010 | Australia |
| Brisbane Sexual Health and HIV Service | Brisbane | Queensland | 4000 | Australia |
| Southern Alberta Clinic | Calgary | Alberta | T2R OX7 | Canada |
| University Health Network - Toronto General Hospital | Toronto | Ontario | M5G 2N2 | Canada |
| Clinic Opus/Lori | Montreal | Quebec | H3A 1T1 | Canada |
| Klinikum der Universitat Zu Koln | Cologne | 50937 | Germany |
| Universitätsklinikum Düsseldorf, Klinik für Gastroenterologie, Hepatologie und Infektiologie, MX-Ambulanz | Düsseldorf | 40225 | Germany |
| Nagoya Medical Center | Nagoya | 460-0001 | Japan |
| Instituto Nacional de Ciencias Medicas y Nutriciòn Salvador Zubiran | Mexico City | Tlalpan DF | 14000 | Mexico |
| Chulalongkorn University Hospital | Bangkok | 10330 | Thailand |
| Western General Hospital | Edinburgh | Lothian | United Kingdom |
| Brighton & Sussex University NHS Trust | Brighton | Sussex | United Kingdom |
| ID | Term |
|---|---|
| D011507 | Proteinuria |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| D000068679 | Emtricitabine |
| D015215 | Zidovudine |
| C106538 | abacavir |
| D019259 | Lamivudine |
| D000069446 | Atazanavir Sulfate |
| D061466 | Lopinavir |
| D000069454 | Darunavir |
| C426859 | fosamprenavir |
| D019438 | Ritonavir |
| D000077592 | Maraviroc |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D013936 | Thymidine |
| D015224 | Dideoxynucleosides |
| D016047 | Zalcitabine |
| D011725 | Pyridines |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011744 | Pyrimidinones |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D005663 | Furans |
| D013844 | Thiazoles |
| D001393 | Azoles |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D014230 | Triazoles |
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