Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:12 AM
Study NCT ID:
NCT01335620
Status:
COMPLETED
Last Update Posted:
2019-11-20
First Post:
2011-03-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
The Safety, Pharmacokinetic Profile and Efficacy of Raltegravir in HIV-infected Patients at Least 60 Years of Age
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068898', 'term': 'Raltegravir Potassium'}, {'id': 'D000068698', 'term': 'Tenofovir'}, {'id': 'D000068679', 'term': 'Emtricitabine'}], 'ancestors': [{'id': 'D011760', 'term': 'Pyrrolidinones'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'a.winston@imperial.ac.uk', 'phone': '+442033121603', 'title': 'Alan Winston', 'phoneExt': '21603', 'organization': 'Imperial College London'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Truvada Plus Raltegravir', 'description': 'Single arm study\n\nRaltegravir: 400 mg twice daily', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Drug Levels in Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Truvada Plus Raltegravir', 'description': 'Single arm study\n\nRaltegravir: 400 mg twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '1732', 'groupId': 'OG000', 'lowerLimit': '969', 'upperLimit': '3095'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 28', 'description': 'rategravir concentration', 'unitOfMeasure': 'ng/ml', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Changes in Haematology, Biochemistry and Virology Tests', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Truvada Plus Raltegravir', 'description': 'Single arm study\n\nRaltegravir: 400 mg twice daily'}], 'timeFrame': '6 months', 'description': 'full blood count, electrolytes and blood lipids will be measured at all visits to assess for changes through out the study. HIV viral load will also be measured to assess the efficacy of the medication at controlling the virus', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collected'}, {'type': 'SECONDARY', 'title': 'Cardiovascular Disease Markers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Truvada Plus Raltegravir', 'description': 'Single arm study\n\nRaltegravir: 400 mg twice daily'}], 'timeFrame': '6 months', 'description': '• To investigate cardiovascular disease markers before and after a switch in antiretroviral therapy to raltegravir.', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collected'}, {'type': 'SECONDARY', 'title': 'Cerebral Function; Changes in Global Cognitive Z-score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Truvada Plus Raltegravir', 'description': 'Single arm study\n\nRaltegravir: 400 mg twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.91', 'spread': '1.3', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.018', 'groupIds': ['OG000'], 'groupDescription': 'Compare baseline to 24 weeks', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Cerebral function via cognitive testing before and after a switch in antiretroviral therapy to raltegravir.\n\nMean Scores from the eight tasks (NPZ-8) assessed were used to derive a global composite measure of neurocognitive function. The result shows the change before and after switch, an increase in z-score represents an improvement in cognitive function assessed by CogState battery, required approximately 10-15 min for completion.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Truvada Plus Raltegravir', 'description': 'Single arm study\n\nRaltegravir: 400 mg twice daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Truvada Plus Raltegravir', 'description': 'Single arm study\n\nRaltegravir: 400 mg twice daily'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66', 'spread': '3.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'HIV affected over 60 years old'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-31', 'studyFirstSubmitDate': '2011-03-25', 'resultsFirstSubmitDate': '2019-09-10', 'studyFirstSubmitQcDate': '2011-04-13', 'lastUpdatePostDateStruct': {'date': '2019-11-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-10-31', 'studyFirstPostDateStruct': {'date': '2011-04-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Drug Levels in Blood', 'timeFrame': 'Day 28', 'description': 'rategravir concentration'}, {'measure': 'Changes in Haematology, Biochemistry and Virology Tests', 'timeFrame': '6 months', 'description': 'full blood count, electrolytes and blood lipids will be measured at all visits to assess for changes through out the study. HIV viral load will also be measured to assess the efficacy of the medication at controlling the virus'}], 'secondaryOutcomes': [{'measure': 'Cardiovascular Disease Markers', 'timeFrame': '6 months', 'description': '• To investigate cardiovascular disease markers before and after a switch in antiretroviral therapy to raltegravir.'}, {'measure': 'Cerebral Function; Changes in Global Cognitive Z-score', 'timeFrame': '6 months', 'description': 'Cerebral function via cognitive testing before and after a switch in antiretroviral therapy to raltegravir.\n\nMean Scores from the eight tasks (NPZ-8) assessed were used to derive a global composite measure of neurocognitive function. The result shows the change before and after switch, an increase in z-score represents an improvement in cognitive function assessed by CogState battery, required approximately 10-15 min for completion.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV', 'Pharmatokinetic', '60 years old', 'Raltegravir'], 'conditions': ['HIV']}, 'referencesModule': {'references': [{'pmid': '25777188', 'type': 'RESULT', 'citation': 'Vera JH, Jackson A, Dickinson L, Else L, Barber T, Mora-Peris B, Back D, Boffito M, Winston A. The pharmacokinetic profile of raltegravir-containing antiretroviral therapy in HIV-infected individuals over 60 years of age. HIV Clin Trials. 2015 Jan-Feb;16(1):39-42. doi: 10.1179/1528433614Z.0000000006. Epub 2015 Jan 14.'}]}, 'descriptionModule': {'briefSummary': 'This is a phase IV, open label, prospective, one phase pharmacokinetic and observational study.\n\nTwenty HIV-1 infected subjects will be recruited, subjects will switch antiretroviral therapy to:\n\n* tenofovir/emtricitabine 245/200 mg daily (Truvada™) plus\n* raltegravir 400 mg twice daily On day 28, all subjects will attend for an intensive 24 hour pharmacokinetic visit.', 'detailedDescription': 'This is a phase IV, open label, prospective, one phase pharmacokinetic and observational study.\n\nTwenty HIV-1 infected subjects will be recruited. Eligible subjects will currently be receiving stable antiretroviral therapy with undetectable plasma HIV RNA and have no evidence of previous HIV- resistance mutations on genotypic resistance testing.\n\nAt baseline, subjects will switch antiretroviral therapy to:\n\n* tenofovir/emtricitabine 245/200 mg daily (Truvada™) plus\n* raltegravir 400 mg twice daily On day 28, all subjects will attend for an intensive 24 hour pharmacokinetic visit.\n\nFollow up over 6 months, subjects will attend on days 14, 90 and 180 for follow up visits that will include standard safety parameters. Assessment of cardiac biomarkers at baseline and on days 90 and 180 and assessment of neurocognitive function at screening, baseline and on day 180 will also be undertaken.\n\nFollowing completion of this study, subjects will recommence their usual antiretroviral treatment regimen and attend for a study follow up visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. HIV-1 infected males or females\n2. 60 years of age or greater\\*\n3. signed informed consent\n4. willing to switch therapy as per study protocol\n5. no previous exposure to raltegravir or HIV-1 integrase inhibitors\n6. plasma HIV RNA \\< 50 copies/mL at screening and on at least one other occasion over the last 3 months\n7. currently receiving a stable antiretroviral regimen with no antiretroviral drug switches for at least 3 months\n8. no previous clinically-significant resistance documented on HIV-1 genotypic resistance\n9. subjects in good health upon medical history, physical exam, and laboratory testing\n10. BMI above or equal to 18 and below 32\n11. Male subjects who are heterosexually active must use two forms of barrier contraception (e.g., condom with spermicide) during heterosexual intercourse, from screening through completion of the study.\n12. Have local screening laboratory results (haematology and chemistry that fall within the normal range of the central laboratory's reference ranges unless the results have been determined by the Investigator to have no clinical significance \\* 50% of total enrolled cohort will be 65 years of age or over. Subsequent to 10 subjects aged between 60 and 64 recruited, only subjects aged 65 or over will be eligible.\n\nExclusion Criteria:\n\n1. current alcohol abuse or drug dependence\n2. positive urine drug of abuse screening\n3. active opportunistic infection or significant co-morbidities\n4. current disallowed concomitant medication"}, 'identificationModule': {'nctId': 'NCT01335620', 'briefTitle': 'The Safety, Pharmacokinetic Profile and Efficacy of Raltegravir in HIV-infected Patients at Least 60 Years of Age', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College London'}, 'officialTitle': 'An Open Label Study to Investigate the Safety, Pharmacokinetic Profile and Efficacy of Raltegravir in HIV-infected Patients at Least 60 Years of Age', 'orgStudyIdInfo': {'id': 'RTG_60'}, 'secondaryIdInfos': [{'id': '2010-022907-23', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Tenofovir/Emtricitabine and Raltegravir', 'description': 'Single arm study\n\ntenofovir/emtricitabine 245/200 mg once daily and raltegravir 400 mg twice daily', 'interventionNames': ['Drug: Raltegravir', 'Drug: Tenofovir', 'Drug: Emtricitabine']}], 'interventions': [{'name': 'Raltegravir', 'type': 'DRUG', 'otherNames': ['Isentress'], 'description': '400 mg twice daily', 'armGroupLabels': ['Tenofovir/Emtricitabine and Raltegravir']}, {'name': 'Tenofovir', 'type': 'DRUG', 'description': '245 mg once daily', 'armGroupLabels': ['Tenofovir/Emtricitabine and Raltegravir']}, {'name': 'Emtricitabine', 'type': 'DRUG', 'description': '200mg once daily', 'armGroupLabels': ['Tenofovir/Emtricitabine and Raltegravir']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SW10 9TH', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Chelsea & Westminster Hospital NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'W2 1NY', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Imperial College Healthcare NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Alan Winston, MB BH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imperial College London'}, {'name': 'Marta Boffito', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chelsea & Westminster Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}