Ignite Creation Date:
2025-12-24 @ 10:38 PM
Ignite Modification Date:
2026-04-14 @ 12:02 PM
Study NCT ID:
NCT01236235
Status:
COMPLETED
Last Update Posted:
2013-09-05
First Post:
2010-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on Long Term Outcomes of Atazanavir in Antiretroviral-naïve Human Immunodeficiency Virus (HIV) Patients in Real Life Setting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 525}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-04', 'studyFirstSubmitDate': '2010-11-05', 'studyFirstSubmitQcDate': '2010-11-05', 'lastUpdatePostDateStruct': {'date': '2013-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients remaining on ATV-based treatment over time', 'timeFrame': 'Up to 5.5 years', 'description': 'Every 6 months from ATV initiation till July 2013 at the latest (maximum follow-up time up to 5.5 years)'}], 'secondaryOutcomes': [{'measure': 'Time to discontinuation of ATV', 'timeFrame': 'Every 6 months up to 5.5 years'}, {'measure': 'Reasons for ATV discontinuation', 'timeFrame': 'Every 6 months up to 5.5 years'}, {'measure': 'Percent of patients with HIV-1 ribonucleic acid (RNA) < 50 and < 500 c/mL', 'timeFrame': 'Every 6 months up to 5.5 years'}, {'measure': 'Mean change in HIV-1 RNA', 'timeFrame': 'Every 6 months up to 5.5 years'}, {'measure': 'Time to viral failure (HIV-1 RNA ≥ 50 and ≥ 500 c/mL)', 'timeFrame': 'Every 6 months up to 5.5 years'}, {'measure': 'Mean change in Cluster of differentiation 4 (CD4) cell count', 'timeFrame': 'Every 6 months up to 5.5 years'}, {'measure': 'Adverse events (AEs) related to ATV', 'timeFrame': 'Every 6 months up to 5.5 years'}, {'measure': 'Lipid profile', 'timeFrame': 'Every 6 months up to 5.5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['HIV']}, 'referencesModule': {'references': [{'pmid': '26899539', 'type': 'DERIVED', 'citation': 'Teofilo E, Rocha-Pereira N, Kuhlmann B, Antela A, Knechten H, Santos J, Jimenez-Exposito MJ; REMAIN study group. Long-Term Efficacy, Tolerability, and Renal Safety of Atazanavir/Ritonavir-based Antiretroviral Therapy in a Cohort of Treatment-Naive Patients with HIV-1 Infection: the REMAIN Study. HIV Clin Trials. 2016 Feb;17(1):17-28. doi: 10.1080/15284336.2015.1112494.'}], 'seeAlsoLinks': [{'url': 'http://www.bms.com/clinical_trials/Pages/home.aspx', 'label': 'BMS Clinical Trials Disclosure'}, {'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}, {'url': 'http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to describe long term (\\> 96 weeks) efficacy and safety of Atazanavir-based regimens in real life setting.', 'detailedDescription': 'Time perspective: Collection of historical data and longitudinal follow up. Patients will be enrolled in 2011/2012 but data will be collected from medical charts from ATV initiation date (Feb 2008 - July 2010) until July 2013 at the latest (if no ATV discontinuation, or death, or lost to follow up).\n\nNon probability sample:\n\n* Specialized HIV management centers will be contacted in order to recruit about 15-20 sites per country.\n* Each site will have to enroll an average of 8-12 consecutive patients (min:5; max:30) fulfilling the inclusion/exclusion criteria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients attending HIV specialized management centers will be considered.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or Female HIV patients ≥ 18 years old at ATV/RTV initiation treatment date\n* Outpatient seen in routine consultation whatever the reason, between January 1st 2011 and March 31st 2012\n* Commencing an ATV/RTV-based regimen including at least 2 nucleoside reverse transcriptase inhibitors (NRTI) after February 1st 2008 and before July 31st 2010, regardless of the current ARV treatment ongoing at enrollment visit\n\nExclusion Criteria:\n\n* Patient exposed to or who began ATV/RTV prior to February 1st 2008, or after July 31st 2010 or without a known start date for ATV/RTV therapy\n* Exposure to more than 4 weeks of any ARV prior to initiation of ATV/RTV treatment\n* Participation in a clinical trial with ATV at the time of or after initiation of ATV/RTV-based regimen'}, 'identificationModule': {'nctId': 'NCT01236235', 'acronym': 'REMAIN', 'briefTitle': 'Study on Long Term Outcomes of Atazanavir in Antiretroviral-naïve Human Immunodeficiency Virus (HIV) Patients in Real Life Setting', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Non Comparative Observational Study to Describe the Duration and Outcome of Treatment in Therapy naïve HIV Positive Patients Initiated on Atazanavir (ATV)/ Ritonavir (RTV)-Based Highly Active Antiretroviral Therapy (HAART) Regimens', 'orgStudyIdInfo': {'id': 'AI424-401'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ARV-naïve HIV patients initiated on ATV/RTV-based therapy', 'description': 'Anti-retroviral (ARV)-naïve HIV patients initiated on ATV/RTV-based therapy between 2008-2010\n\nOne cohort being observed for 3 different countries'}]}, 'contactsLocationsModule': {'locations': [{'zip': '52062', 'city': 'Aachen', 'country': 'Germany', 'facility': 'Local Institution', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'zip': '10243', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Local Institution', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '10551', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Local Institution', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '10777', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Local Institution', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13347', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Local Institution', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Local Institution', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '14057', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Local Institution', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '40237', 'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Local Institution', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '79106', 'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'Local Institution', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '20099', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Local Institution', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '20146', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Local Institution', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '30159', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Local Institution', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '68161', 'city': 'Mannheim', 'country': 'Germany', 'facility': 'Local Institution', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'zip': '80801', 'city': 'München', 'country': 'Germany', 'facility': 'Local Institution', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '93053', 'city': 'Regensburg', 'country': 'Germany', 'facility': 'Local Institution', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}, {'zip': '70197', 'city': 'Stuttgart', 'country': 'Germany', 'facility': 'Local Institution', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}, {'zip': '3814501', 'city': 'Aveiro', 'country': 'Portugal', 'facility': 'Local Institution', 'geoPoint': {'lat': 40.64575, 'lon': -8.64643}}, {'zip': '2830094', 'city': 'Barreiro', 'country': 'Portugal', 'facility': 'Local Institution', 'geoPoint': {'lat': 38.66314, 'lon': -9.0724}}, {'zip': '1150199', 'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Local Institution', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '1169050', 'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Local Institution', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '1349019', 'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Local Institution', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '1649028', 'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Local Institution', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '8500338', 'city': 'Portimão', 'country': 'Portugal', 'facility': 'Local Institution', 'geoPoint': {'lat': 37.13856, 'lon': -8.53775}}, {'zip': '4099001', 'city': 'Porto', 'country': 'Portugal', 'facility': 'Local Institution', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}, {'zip': '4369004', 'city': 'Porto', 'country': 'Portugal', 'facility': 'Local Institution', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}, {'zip': '2801951', 'city': 'Pragal', 'country': 'Portugal', 'facility': 'Local Institution', 'geoPoint': {'lat': 38.67459, 'lon': -9.16981}}, {'zip': '2005177', 'city': 'Santarém', 'country': 'Portugal', 'facility': 'Local Institution', 'geoPoint': {'lat': 39.23379, 'lon': -8.68617}}, {'zip': '3041801', 'city': 'São Martinho do Bispo', 'country': 'Portugal', 'facility': 'Local Institution', 'geoPoint': {'lat': 40.21021, 'lon': -8.45692}}, {'zip': '4434502', 'city': 'Vila Nova de Gaia', 'country': 'Portugal', 'facility': 'Local Institution', 'geoPoint': {'lat': 41.12401, 'lon': -8.61241}}, {'zip': '28922', 'city': 'Alcorcón', 'country': 'Spain', 'facility': 'Local Institution', 'geoPoint': {'lat': 40.34582, 'lon': -3.82487}}, {'zip': '08916', 'city': 'Badalona', 'country': 'Spain', 'facility': 'Local Institution', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'zip': '08003', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Local Institution', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Local Institution', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08041', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Local Institution', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '18014', 'city': 'Granada', 'country': 'Spain', 'facility': 'Local Institution', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'zip': '08402', 'city': 'Granollers', 'country': 'Spain', 'facility': 'Local Institution', 'geoPoint': {'lat': 41.60797, 'lon': 2.28773}}, {'zip': '19002', 'city': 'Guadalajara', 'country': 'Spain', 'facility': 'Local Institution', 'geoPoint': {'lat': 40.62862, 'lon': -3.16185}}, {'zip': '11407', 'city': 'Jerez de la Frontera', 'country': 'Spain', 'facility': 'Local Institution', 'geoPoint': {'lat': 36.68645, 'lon': -6.13606}}, {'zip': '28911', 'city': 'Leganés', 'country': 'Spain', 'facility': 'Local Institution', 'geoPoint': {'lat': 40.32718, 'lon': -3.7635}}, {'zip': '26006', 'city': 'Logroño', 'country': 'Spain', 'facility': 'Local Institution', 'geoPoint': {'lat': 42.46615, 'lon': -2.45115}}, {'zip': '28006', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Local Institution', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28034', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Local Institution', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '29603', 'city': 'Marbella', 'country': 'Spain', 'facility': 'Local Institution', 'geoPoint': {'lat': 36.51543, 'lon': -4.88583}}, {'zip': '08304', 'city': 'Mataró', 'country': 'Spain', 'facility': 'Local Institution', 'geoPoint': {'lat': 41.54211, 'lon': 2.4445}}, {'zip': '29010', 'city': 'Málaga', 'country': 'Spain', 'facility': 'Local Institution', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '28935', 'city': 'Móstoles', 'country': 'Spain', 'facility': 'Local Institution', 'geoPoint': {'lat': 40.32234, 'lon': -3.86496}}, {'zip': '15706', 'city': 'Santiago de Compostela', 'country': 'Spain', 'facility': 'Local Institution', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}, {'zip': '41013', 'city': 'Seville', 'country': 'Spain', 'facility': 'Local Institution', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '43003', 'city': 'Tarragona', 'country': 'Spain', 'facility': 'Local Institution', 'geoPoint': {'lat': 41.11905, 'lon': 1.24544}}, {'zip': '46014', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Local Institution', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46015', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Local Institution', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46026', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Local Institution', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '50009', 'city': 'Zaragoza', 'country': 'Spain', 'facility': 'Local Institution', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'PharmaNet', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}