Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2026-02-23 @ 4:55 AM
Study NCT ID:
NCT00823966
Status:
COMPLETED
Last Update Posted:
2010-07-05
First Post:
2009-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety And Efficacy Of Rescriptor In Patients For Human Immunodeficiency Virus (HIV) Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020008', 'term': 'Delavirdine'}], 'ancestors': [{'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTraials.govCallCenter@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTraials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'There is not enough data to analyze on the efficacy and safety of delavirdine mesylate in the 3 subjects with HIV infection assessed during this study.'}}, 'adverseEventsModule': {'timeFrame': 'One year', 'eventGroups': [{'id': 'EG000', 'title': 'Delavirdine Mesilate', 'description': 'RESCRIPTOR® TABLETS 200mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. "The usual adult dose is 400mg of Delavirdine Mesilate administered orally 3 times daily.This drug must always be administered in combination with other anti-human immunodeficiency virus (HIV) drugs."', 'otherNumAtRisk': 3, 'otherNumAffected': 2, 'seriousNumAtRisk': 3, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA J12.0'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA J12.0'}], 'seriousEvents': [{'term': 'Pneumocystis jiroveci pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA J12.0'}, {'term': 'hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA J12.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Reported Unlisted Adverse Drug Reaction.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Delavirdine Mesilate', 'description': 'RESCRIPTOR® TABLETS 200mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. "The usual adult dose is 400mg of Delavirdine Mesilate administered orally 3 times daily.This drug must always be administered in combination with other anti-human immunodeficiency virus (HIV) drugs."'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'One Year', 'description': 'Adverse drug reaction that is not listed in the Japanese Package Insert(Same as Local product Document).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis population included enrolled subjects who had received at least 1 confirmed, administration of delavirdine mesylate.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Improved in Number of HIV- Ribonucleic Acid (RNA) Copies, Cluster of Differentiation 4(CD4) Count, and Not Progress in HIV Classification: Centers for Disease Control and Prevention Clinical Category (CDC Category).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Delavirdine Mesilate', 'description': 'RESCRIPTOR® TABLETS 200mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. "The usual adult dose is 400mg of Delavirdine Mesilate administered orally 3 times daily.This drug must always be administered in combination with other anti-human immunodeficiency virus (HIV) drugs."'}], 'classes': [{'title': 'Number of HIV-RNA', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'CD4', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'CDC category', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'One year', 'description': 'Improvement of number of HIV-RNA copies; Improvement is measured by general evaluation of decrease in HIV-RNA copies.\n\nImprovement of CD4 counts; Improvement is measured by general evaluation of increase in CD4 counts.\n\nNot progress in HIV classification (severity of CDC category); Subjects were classified based on the severity of CDC category as mild (Category A), moderate (Category B), and severe (Category C). No change categories from Category A to Category B / Category C, or from Category B to Category C in CDC category.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis population included all subjects from the safety analysis population in whom the efficacy of this drug could be evaluated.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Delavirdine Mesilate', 'description': 'RESCRIPTOR® TABLETS 200mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. "The usual adult dose is 400mg of Delavirdine Mesilate administered orally 3 times daily.This drug must always be administered in combination with other anti-human immunodeficiency virus (HIV) drugs."'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '08 December 2003 to 31 March 2009, a total of two centers in Japan'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Delavirdine Mesilate', 'description': 'RESCRIPTOR® TABLETS 200mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. "The usual adult dose is 400mg of Delavirdine Mesilate administered orally 3 times daily.This drug must always be administered in combination with other anti-human immunodeficiency virus (HIV) drugs."'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-06-02', 'studyFirstSubmitDate': '2009-01-14', 'resultsFirstSubmitDate': '2010-03-04', 'studyFirstSubmitQcDate': '2009-01-15', 'lastUpdatePostDateStruct': {'date': '2010-07-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-06-02', 'studyFirstPostDateStruct': {'date': '2009-01-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-07-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Reported Unlisted Adverse Drug Reaction.', 'timeFrame': 'One Year', 'description': 'Adverse drug reaction that is not listed in the Japanese Package Insert(Same as Local product Document).'}, {'measure': 'Number of Participants Who Improved in Number of HIV- Ribonucleic Acid (RNA) Copies, Cluster of Differentiation 4(CD4) Count, and Not Progress in HIV Classification: Centers for Disease Control and Prevention Clinical Category (CDC Category).', 'timeFrame': 'One year', 'description': 'Improvement of number of HIV-RNA copies; Improvement is measured by general evaluation of decrease in HIV-RNA copies.\n\nImprovement of CD4 counts; Improvement is measured by general evaluation of increase in CD4 counts.\n\nNot progress in HIV classification (severity of CDC category); Subjects were classified based on the severity of CDC category as mild (Category A), moderate (Category B), and severe (Category C). No change categories from Category A to Category B / Category C, or from Category B to Category C in CDC category.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['HIV-1 Infection']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4351010&StudyName=Safety%20And%20Efficacy%20Of%20Rescriptor%20In%20Patients%20For%20HIV%20Patients', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the Local Product Document (LPD) (unlisted adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.', 'detailedDescription': 'All the patients whom an investigator prescribes the first Rescriptor® should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The patients whom an investigator involving A4351010 prescribes the Delavirdine Mesilate(Rescriptor).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients need to be administered Rescriptor® in order to be enrolled in the surveillance.\n\nExclusion Criteria:\n\nPatients not administered Rescriptor®.'}, 'identificationModule': {'nctId': 'NCT00823966', 'briefTitle': 'Safety And Efficacy Of Rescriptor In Patients For Human Immunodeficiency Virus (HIV) Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Drug Use Investigation For Rescriptor (Regulatory Post Marketing Commitment Plan)', 'orgStudyIdInfo': {'id': 'A4351010'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Delavirdine Mesilate', 'description': 'Patients administered.', 'interventionNames': ['Drug: Rescriptor']}], 'interventions': [{'name': 'Rescriptor', 'type': 'DRUG', 'otherNames': ['Rescripter'], 'description': 'RESCRIPTOR® TABLETS 200mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. "The usual adult dose is 400mg of Delavirdine Mesilate administered orally 3 times daily.This drug must always be administered in combination with other anti-HIV drugs."', 'armGroupLabels': ['Delavirdine Mesilate']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Director, Clinical Trial Disclosure Group', 'oldOrganization': 'Pfizer, Inc.'}}}}