MARCH Renal Substudy (MARCHrenal)
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ClinicalTrials.gov Identifier: NCT01637259 |
Recruitment Status
:
Completed
First Posted
: July 11, 2012
Last Update Posted
: January 20, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Proteinuria HIV | 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 | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 76 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Official Title: | Maraviroc Switch Collaborative Study Renal Substudy |
Study Start Date : | June 2012 |
Actual Primary Completion Date : | December 2015 |
Actual Study Completion Date : | December 2015 |

Arm | Intervention/treatment |
---|---|
Active Comparator: NRTI + PI
arm 1
|
Drug: arm 1 nucleotide analogue reverse transcriptase inhibitors and boosted protease inhibitors
NRTI + PI
Other Names:
|
Active Comparator: PI + maraviroc
arm 2
|
Drug: Arm 2 boosted protease inhibitors and maraviroc
PI + maraviroc
Other Names:
|
Active Comparator: NRTI + maraviroc
arm 3
|
Drug: Arm 3 nucleotide analogue reverse transcriptase inhibitors and maraviroc
NRTI + maraviroc
Other Names:
|
- 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.
- 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;

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01637259
Argentina | |
Hospital Italiano de Buenos Aires | |
Buenos Aires, Ciudad de Buenos Aires, Argentina, C1181ACH | |
Hospital General de Agudos J M Ramos Mejia | |
Buenos Aires, Ciudad de Buenos Aires, Argentina, C1221ADC | |
Fundación IDEAA | |
Buenos Aires, Ciudad de Buenos Aires, Argentina, C1405CKC | |
Australia, New South Wales | |
St. Vincent's Hospital | |
Sydney, New South Wales, Australia, 2010 | |
Australia, Queensland | |
Brisbane Sexual Health and HIV Service | |
Brisbane, Queensland, Australia, 4000 | |
Canada, Alberta | |
Southern Alberta Clinic | |
Calgary, Alberta, Canada, T2R OX7 | |
Canada, Ontario | |
University Health Network - Toronto General Hospital | |
Toronto, Ontario, Canada, M5G 2N2 | |
Canada, Quebec | |
Clinic Opus/Lori | |
Montreal, Quebec, Canada, H3A 1T1 | |
Germany | |
Klinikum der Universitat Zu Koln | |
Cologne, Germany, 50937 | |
Universitätsklinikum Düsseldorf, Klinik für Gastroenterologie, Hepatologie und Infektiologie, MX-Ambulanz | |
Dusseldorf, Germany, 40225 | |
Japan | |
Nagoya Medical Center | |
Nagoya, Japan, 460-0001 | |
Mexico | |
Instituto Nacional de Ciencias Medicas y Nutriciòn Salvador Zubiran | |
Mexico City, Tlalpan DF, Mexico, 14000 | |
Thailand | |
Chulalongkorn University Hospital | |
Bangkok, Thailand, 10330 | |
United Kingdom | |
Western General Hospital | |
Edinburgh, Lothian, United Kingdom | |
Brighton & Sussex University NHS Trust | |
Brighton, Sussex, United Kingdom |
Principal Investigator: | Waldo Belloso, MD | Hospital Italiano de Buenos Aires | |
Principal Investigator: | Mark Kelly, MD | Brisbane Sexual Health and HIV Service |
Responsible Party: | Kirby Institute |
ClinicalTrials.gov Identifier: | NCT01637259 History of Changes |
Other Study ID Numbers: |
MARCH-Kirby renal |
First Posted: | July 11, 2012 Key Record Dates |
Last Update Posted: | January 20, 2016 |
Last Verified: | January 2016 |
Keywords provided by Kirby Institute:
proteinuria HIV |
Additional relevant MeSH terms:
Proteinuria Urination Disorders Urologic Diseases Urological Manifestations Signs and Symptoms Ritonavir Lopinavir Darunavir Atazanavir Sulfate HIV Protease Inhibitors Fosamprenavir Tenofovir Lamivudine Emtricitabine Zidovudine |
Maraviroc Abacavir Protease Inhibitors Reverse Transcriptase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Nucleic Acid Synthesis Inhibitors Antimetabolites CCR5 Receptor Antagonists |