Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2026-01-01 @ 1:00 PM
Study NCT ID:
NCT01065792
Status:
COMPLETED
Last Update Posted:
2015-07-21
First Post:
2010-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stocrin Re-examination Study (0831-028)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['South Korea']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 728}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-20', 'studyFirstSubmitDate': '2010-02-08', 'studyFirstSubmitQcDate': '2010-02-08', 'lastUpdatePostDateStruct': {'date': '2015-07-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of patients with any adverse experience', 'timeFrame': 'Up to 14 days following cessation of treatment'}, {'measure': 'Proportion of patients with HIV-1 RNA levels of less than 400 copies per milliliter after treatment', 'timeFrame': 'At 12 weeks +/- 2 weeks and at 24 weeks +/- 2 weeks after first treatment'}, {'measure': 'Change from baseline in CD4 cell count and overall efficacy evaluation by investigator (success, failure or can not be assessed)', 'timeFrame': 'At 12 weeks +/- 2 weeks and at 24 weeks +/- 2 weeks after first treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV Infection'], 'conditions': ['HIV Infection']}, 'descriptionModule': {'briefSummary': 'This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of STOCRIN through collecting the safety and efficacy information according to the Re-examination Regulation for New Drugs.\n\nPost-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '3 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with HIV-1 infection treated with STOCRIN', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV-1 Infected Patient\n* Patient Who Is Treated With Stocrin 600 Mg Tablet Within Local Label During The Enrollment Period (A Patient Who Changes The Therapy From Stocrin 200 Mg Capsule To Stocrin 600 Mg Tablet Can Be Eligible.)\n\nExclusion Criteria:\n\n* Patient Who Has A Contraindication To Stocrin According To The Local Label'}, 'identificationModule': {'nctId': 'NCT01065792', 'briefTitle': 'Stocrin Re-examination Study (0831-028)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of STOCRIN in Usual Practice', 'orgStudyIdInfo': {'id': '0831-028'}, 'secondaryIdInfos': [{'id': '2010_008', 'type': 'OTHER', 'domain': 'Merck'}]}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Patients with HIV-1 infection taking Stocrin'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}