Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-04-18 @ 7:59 AM
Study NCT ID:
NCT02116751
Status:
COMPLETED
Last Update Posted:
2014-12-09
First Post:
2014-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Frequency and Clinical Significance of Renal and Bone Toxicity in HIV-infected Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 306}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-06', 'studyFirstSubmitDate': '2014-04-11', 'studyFirstSubmitQcDate': '2014-04-15', 'lastUpdatePostDateStruct': {'date': '2014-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Changes in renal and bone toxicity', 'timeFrame': '2 years before entry', 'description': 'Evolution of renal and bone parameters in case of regimen discontinuation'}], 'primaryOutcomes': [{'measure': 'Incidence of Renal and Bone toxicity', 'timeFrame': 'Patients will be evaluated for 2 years before', 'description': 'Number and percentage of patients with:\n\n* Confirmed estimated glomerular filtration rate (eGFR) by CKD (chronic kidney disease)-epi equation decrease to \\< 60 ml/min, or/and\n* More than 25% of eGFR decrease during therapy, or/and\n* Tubular toxicity defined as at least two of confirmed proteinuria (\\> 300 mg/g), glycosuria with euglycemia, fractional excretion of urinary phosphate \\> 20%, or of uric acid \\> 10%. AND\n* Number and percentage of patients with bone mineral density (BMD) decrease \\> 10% during follow up or progression to osteopenia (from normal) or to osteoporosis (from osteopenia)'}], 'secondaryOutcomes': [{'measure': 'Consequences of renal or bone toxicity', 'timeFrame': 'Patients will be evaluated for 2 years before', 'description': 'Percentage of patients with regimen discontinuation (any drug in the regimen) because of renal or/and bone toxicity'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV, antiretroviral, toxicity, eGFR, tubular disease, BMD'], 'conditions': ['Renal Toxicity']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the frequency of renal and bone toxicity in HIV infected patients receiving antiretroviral therapy, and the outcome in terms of treatment change or/and virological failure, in relation with the presence of classical factors, such as diabetes or hypertension, the role of HIV itself, because of chronic inflammation, and the effects of antiretroviral medication.', 'detailedDescription': 'This is a retrospective cohort study involving 300 patients to determine the frequency of renal and bone comorbidities/toxicity in a large population of HIV-infected patients receiving antiretroviral therapy, in order to establish the differential role of classical factors, HIV infection, or antiretroviral therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'HIV infected patients in active follow up, receiving antiretroviral therapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed HIV infection\n\nExclusion Criteria:\n\n* Pregnancy\n* Prior therapy with antineoplastic chemotherapy or chronic treatment with corticosteroids\n* Previous chronic therapy with antiresorptive bone therapy'}, 'identificationModule': {'nctId': 'NCT02116751', 'acronym': 'ComorVIH', 'briefTitle': 'Frequency and Clinical Significance of Renal and Bone Toxicity in HIV-infected Patients', 'organization': {'class': 'NETWORK', 'fullName': 'Asociacion para el Estudio de las Enfermedades Infecciosas'}, 'officialTitle': 'Frequency and Clinical Significance of Renal and Bone Toxicity in HIV-infected Patients: Role of Classical Factors, HIV Infection, and Antiretroviral Therapy', 'orgStudyIdInfo': {'id': 'EC 039/14'}}, 'contactsLocationsModule': {'locations': [{'zip': '28034', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Ramon y Cajal Hospital', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Jose L Casado, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ramon y Cajal Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asociacion para el Estudio de las Enfermedades Infecciosas', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}