Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2025-12-26 @ 1:49 AM
Study NCT ID:
NCT01450605
Status:
COMPLETED
Last Update Posted:
2016-04-21
First Post:
2011-10-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Korean Post-marketing Surveillance for Reyataz®
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 601}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-20', 'studyFirstSubmitDate': '2011-10-10', 'studyFirstSubmitQcDate': '2011-10-10', 'lastUpdatePostDateStruct': {'date': '2016-04-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events occurrence', 'timeFrame': '30 days after last dose of study drug', 'description': 'Incidence (per person-time) and confidence interval of overall adverse events and each adverse event will be computed per surveillance period'}], 'secondaryOutcomes': [{'measure': 'Human Immunodeficiency Virus (HIV) Ribonucleic acid (RNA) level before and after drug administration', 'timeFrame': 'Baseline and 16 weeks after first treatment'}, {'measure': 'CD 4 T-cell count before and after drug administration', 'timeFrame': 'Baseline and 16 weeks after first treatment'}, {'measure': "Overall efficacy evaluation by investigator's discretion", 'timeFrame': 'Baseline and 16 weeks after first treatment', 'description': 'Based on laboratory test results including HIV RNA (viral load) and CD4 T-cell count, clinical findings, subjective findings and objective findings in comparison to baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['HIV-1']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bms.com/studyconnect/Pages/home.aspx', 'label': 'BMS clinical trial educational resource'}, {'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this post-marketing surveillance is to investigate and confirm the type and incidence of newly identified adverse events and any other factors affecting safety and efficacy of Reyataz® so that the regulatory authority can manage the marketing approval properly'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients ≥ 13 years of age with HIV-1 who are on Reyataz® treatment at the time of enrollment and have never been participated in this study previously or who are initiating Reyataz® treatment for the first time in the real-life conditions in its registered indication(s) as required by KFDA', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ≥ 13 years of age with HIV-1 who are on Reyataz® treatment at the time of enrollment and have never been participated in this study previously or who are initiating Reyataz® treatment for the first time in the real-life conditions in its registered indication(s) as required by KFDA\n\nExclusion Criteria:\n\n* According to Warning/Caution in local label'}, 'identificationModule': {'nctId': 'NCT01450605', 'briefTitle': 'Korean Post-marketing Surveillance for Reyataz®', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Korean Post-marketing Surveillance for Reyataz®', 'orgStudyIdInfo': {'id': 'AI424-414'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients ≥ 13 years of age with HIV-1', 'description': 'Patients ≥ 13 years of age with HIV-1 who are on Reyataz® treatment at the time of enrollment and have never been participated in this study previously or who are initiating Reyataz® treatment for the first time in the real-life conditions in its registered indication(s) as required by KFDA', 'interventionNames': ['Drug: No Intervention']}], 'interventions': [{'name': 'No Intervention', 'type': 'DRUG', 'description': 'Patients are previously on Reyataz® treatment or initiated Reyataz® for the first time', 'armGroupLabels': ['Patients ≥ 13 years of age with HIV-1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-756', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Local Institution', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}