Ignite Creation Date:
2025-12-24 @ 2:47 PM
Ignite Modification Date:
2025-12-28 @ 12:40 PM
Study NCT ID:
NCT01637259
Status:
COMPLETED
Last Update Posted:
2016-01-20
First Post:
2012-06-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MARCH Renal Substudy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Chile', 'France']}, 'conditionBrowseModule': {'meshes': [{'id': 'D011507', 'term': 'Proteinuria'}], 'ancestors': [{'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068698', 'term': 'Tenofovir'}, {'id': 'D000068679', 'term': 'Emtricitabine'}, {'id': 'D015215', 'term': 'Zidovudine'}, {'id': 'C106538', 'term': 'abacavir'}, {'id': 'D019259', 'term': 'Lamivudine'}, {'id': 'D000069446', 'term': 'Atazanavir Sulfate'}, {'id': 'D061466', 'term': 'Lopinavir'}, {'id': 'D000069454', 'term': 'Darunavir'}, {'id': 'C426859', 'term': 'fosamprenavir'}, {'id': 'D019438', 'term': 'Ritonavir'}, {'id': 'D000077592', 'term': 'Maraviroc'}], 'ancestors': [{'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D013936', 'term': 'Thymidine'}, {'id': 'D015224', 'term': 'Dideoxynucleosides'}, {'id': 'D016047', 'term': 'Zalcitabine'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D002219', 'term': 'Carbamates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D005663', 'term': 'Furans'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D014230', 'term': 'Triazoles'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-18', 'studyFirstSubmitDate': '2012-06-27', 'studyFirstSubmitQcDate': '2012-07-10', 'lastUpdatePostDateStruct': {'date': '2016-01-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes in proteinuria and albuminuria between baseline and week 96', 'timeFrame': '96 weeks', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'changes in renal tubular function between baseline and week 96', 'timeFrame': '96 weeks', 'description': 'To evaluate the following aspects of renal function at baseline and changes within and between study groups:\n\n* Tubular function defined as proximal tubular function; ascending thick loop of Henle; distal tubular function; volume and renal potassium handling;\n* Non-tubular function i.e. eGFR; Urine albumin:creatinine ratio;\n* 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;'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['proteinuria', 'HIV'], 'conditions': ['Proteinuria', 'HIV']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of written, informed consent for participation in the substudy\n* Enrolled into the substudy either at or before the week 0 visit of the main study'}, 'identificationModule': {'nctId': 'NCT01637259', 'acronym': 'MARCHrenal', 'briefTitle': 'MARCH Renal Substudy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Kirby Institute'}, 'officialTitle': 'Maraviroc Switch Collaborative Study Renal Substudy', 'orgStudyIdInfo': {'id': 'MARCH-Kirby renal'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'NRTI + PI', 'description': 'arm 1', 'interventionNames': ['Drug: arm 1 nucleotide analogue reverse transcriptase inhibitors and boosted protease inhibitors']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PI + maraviroc', 'description': 'arm 2', 'interventionNames': ['Drug: Arm 2 boosted protease inhibitors and maraviroc']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NRTI + maraviroc', 'description': 'arm 3', 'interventionNames': ['Drug: Arm 3 nucleotide analogue reverse transcriptase inhibitors and maraviroc']}], 'interventions': [{'name': 'arm 1 nucleotide analogue reverse transcriptase inhibitors and boosted protease inhibitors', 'type': 'DRUG', 'otherNames': ['tenofovir', 'emtricitabine', 'zidovudine', 'abacavir', 'lamivudine', 'atazanavir', 'lopinavir', 'darunavir', 'fosamprenavir', 'ritonavir'], 'description': 'NRTI + PI', 'armGroupLabels': ['NRTI + PI']}, {'name': 'Arm 2 boosted protease inhibitors and maraviroc', 'type': 'DRUG', 'otherNames': ['maraviroc', 'atazanavir', 'lopinavir', 'darunavir', 'fosamprenavir', 'ritonavir'], 'description': 'PI + maraviroc', 'armGroupLabels': ['PI + maraviroc']}, {'name': 'Arm 3 nucleotide analogue reverse transcriptase inhibitors and maraviroc', 'type': 'DRUG', 'otherNames': ['maraviroc', 'tenofovir', 'emtricitabine', 'zidovudine', 'abacavir', 'lamivudine'], 'description': 'NRTI + maraviroc', 'armGroupLabels': ['NRTI + maraviroc']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'C1181ACH', 'city': 'Buenos Aires', 'state': 'Buenos Aires F.D.', 'country': 'Argentina', 'facility': 'Hospital Italiano de Buenos Aires', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1221ADC', 'city': 'Buenos Aires', 'state': 'Buenos Aires F.D.', 'country': 'Argentina', 'facility': 'Hospital General de Agudos J M Ramos Mejia', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1405CKC', 'city': 'Buenos Aires', 'state': 'Buenos Aires F.D.', 'country': 'Argentina', 'facility': 'Fundación IDEAA', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '2010', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': "St. Vincent's Hospital", 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '4000', 'city': 'Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Brisbane Sexual Health and HIV Service', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'zip': 'T2R OX7', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Southern Alberta Clinic', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'M5G 2N2', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University Health Network - Toronto General Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H3A 1T1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Clinic Opus/Lori', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '50937', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Klinikum der Universitat Zu Koln', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '40225', 'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Universitätsklinikum Düsseldorf, Klinik für Gastroenterologie, Hepatologie und Infektiologie, MX-Ambulanz', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '460-0001', 'city': 'Nagoya', 'country': 'Japan', 'facility': 'Nagoya Medical Center', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '14000', 'city': 'Mexico City', 'state': 'Tlalpan DF', 'country': 'Mexico', 'facility': 'Instituto Nacional de Ciencias Medicas y Nutriciòn Salvador Zubiran', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '10330', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Chulalongkorn University Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'city': 'Edinburgh', 'state': 'Lothian', 'country': 'United Kingdom', 'facility': 'Western General Hospital', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}, {'city': 'Brighton', 'state': 'Sussex', 'country': 'United Kingdom', 'facility': 'Brighton & Sussex University NHS Trust', 'geoPoint': {'lat': 50.82838, 'lon': -0.13947}}], 'overallOfficials': [{'name': 'Waldo Belloso, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Italiano de Buenos Aires'}, {'name': 'Mark Kelly, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Brisbane Sexual Health and HIV Service'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kirby Institute', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}