Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 4:03 AM
Study NCT ID:
NCT02457494
Status:
COMPLETED
Last Update Posted:
2022-07-20
First Post:
2015-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Kidney Stone Risk Factors in Patients Infected With HIV
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053040', 'term': 'Nephrolithiasis'}, {'id': 'D056844', 'term': 'Renal Colic'}, {'id': 'D000092162', 'term': 'Crystalluria'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'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': 'D052878', 'term': 'Urolithiasis'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-19', 'studyFirstSubmitDate': '2015-05-22', 'studyFirstSubmitQcDate': '2015-05-27', 'lastUpdatePostDateStruct': {'date': '2022-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Qualitative assessment of the cause of the renal stone', 'timeFrame': 'at 6 months', 'description': 'Qualitative assessment of the cause of the renal stone based on different biological and clinical parameters (biochemical analysis of urines, cristalluria, low dose renal CT, patient history, family history…)'}, {'measure': 'Risk profile for recurrence of renal stone', 'timeFrame': 'at 12 months', 'description': 'Risk profile for recurrence of renal stone estimated based on plasma and urinary parameters, nutritional profile and drug exposure'}], 'secondaryOutcomes': [{'measure': 'Follow up outcome of HIV patients over one year to identify prevalence of recurrences and describe co-morbidities associated with stone disease', 'timeFrame': 'up to 12 months'}, {'measure': 'Urological management for renal stones in HIV patients', 'timeFrame': 'up to 12 months'}, {'measure': 'Causes of drug induced renal stones', 'timeFrame': 'up to 12 months'}, {'measure': 'Number of stone recurrences', 'timeFrame': 'at 6 months'}, {'measure': 'Number of stone recurrences', 'timeFrame': 'at 12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CALVIH', 'Renal stone', 'HIV1', 'Renal colic', 'Atazanavir', 'Crystalluria', 'Chronic Kidney Disease', 'Calcium Oxalate'], 'conditions': ['Nephrolithiasis', 'HIV']}, 'referencesModule': {'references': [{'pmid': '25904366', 'type': 'RESULT', 'citation': 'Abgrall S, Rachas A, Tourret J, Isnard-Bagnis C, Billaud E, Tattevin P, Costagliola D, Guiguet M, Durieux P; French Hospital Database on HIV. A multifaceted intervention designed to improve medical management of moderate to advanced chronic kidney disease in HIV-infected patients: a cluster randomized trial. Clin Infect Dis. 2015 Aug 1;61(3):375-84. doi: 10.1093/cid/civ310. Epub 2015 Apr 22.'}, {'pmid': '24052632', 'type': 'RESULT', 'citation': 'Tourret J, Deray G, Isnard-Bagnis C. Tenofovir effect on the kidneys of HIV-infected patients: a double-edged sword? J Am Soc Nephrol. 2013 Oct;24(10):1519-27. doi: 10.1681/ASN.2012080857. Epub 2013 Sep 19.'}, {'pmid': '21745806', 'type': 'RESULT', 'citation': 'Bige N, Lanternier F, Viard JP, Kamgang P, Daugas E, Elie C, Jidar K, Walker-Combrouze F, Peraldi MN, Isnard-Bagnis C, Servais A, Lortholary O, Noel LH, Bollee G. Presentation of HIV-associated nephropathy and outcome in HAART-treated patients. Nephrol Dial Transplant. 2012 Mar;27(3):1114-21. doi: 10.1093/ndt/gfr376. Epub 2011 Jul 10.'}, {'pmid': '19375399', 'type': 'RESULT', 'citation': 'Tourret J, Tostivint I, Deray G, Isnard-Bagnis C. [Kidney diseases in HIV-infected patients]. Nephrol Ther. 2009 Nov;5(6):576-91. doi: 10.1016/j.nephro.2009.02.007. Epub 2009 Apr 16. French.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to define the cause of renal stones and the risk pattern for recurrence of renal stones episodes (any kind of stones) in HIV1 patients.', 'detailedDescription': 'This study aims at defining the cause of renal stones and the risk pattern for recurrence of renal stones episodes (any kind of stones) in HIV1 patients.\n\nPrimary Objective :\n\n* Finding the cause of renal stone in HIV patients defined as stone composition if stone is available or more probable pathophysiological mechanism\n* Risk profile for stone recurrences estimated on risk indices in HIV1 patients\n\nSecondary Objective(s)\n\n* Identify prevalence of recurrences and describe co-morbidities associated with stone disease\n* Describe urological management for renal stones in HIV patients\n* Describe the causes of drug induced renal stones'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult male or female HIV1 infected patients having experienced a renal stone episode within the past six months or living with a renal stone', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult male or female HIV1 infected patients willing to participate in the study\n* Having experienced a renal stone episode within the past six months or living with a renal stone\n* Able to understand the protocol\n* Giving oral consent\n\nExclusion Criteria:\n\n* CT scan impossible\n* Follow up impossible over 1 year'}, 'identificationModule': {'nctId': 'NCT02457494', 'acronym': 'CALVIH', 'briefTitle': 'Kidney Stone Risk Factors in Patients Infected With HIV', 'organization': {'class': 'OTHER', 'fullName': "Association pour le Developpement d'Investigations et de Thérapeutiques en Néphrologie"}, 'officialTitle': 'CALVIH: Determination of Kidney Stone Risk Factors in Patients Infected With HIV', 'orgStudyIdInfo': {'id': 'Al424-986'}}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'Corinne Isnard Bagnis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'corinne i bagnis', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Groupe Hospitalier Pitie Salpetriere et Chaire de Recherche en Education Therapeutique'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corinne Isnard Bagnis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'University Professor and Hospital Practitioner', 'investigatorFullName': 'Corinne Isnard Bagnis', 'investigatorAffiliation': "Association pour le Developpement d'Investigations et de Thérapeutiques en Néphrologie"}}}}