Ignite Creation Date:
2025-12-25 @ 5:18 AM
Ignite Modification Date:
2025-12-26 @ 4:26 AM
Study NCT ID:
NCT00515827
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
2007-08-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effect of Addition of Raltegravir (MK-0518) to PI- or NNRTI-Based ART Regimens in HIV Infected Subjects With Undetectable Viral Load
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068898', 'term': 'Raltegravir Potassium'}], 'ancestors': [{'id': 'D011760', 'term': 'Pyrrolidinones'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ACTGCT.Gov@s-3.com', 'phone': '(301) 628-3313', 'title': 'ACTG ClinicalTrials.gov Coordinator', 'organization': 'ACTG Network Coordinating Center, Social and Scientific Systems, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From study enrollment until study completion', 'description': 'MedDRA 14', 'eventGroups': [{'id': 'EG000', 'title': 'Raltegravir', 'description': 'Baseline to Week 12 for Arm A (Raltegravir then Placebo), and Week 12 to Week 24 for Arm B (Placebo then Raltegravir).', 'otherNumAtRisk': 52, 'otherNumAffected': 10, 'seriousNumAtRisk': 52, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Week 12 to Week 24 for Arm A (Raltegravir then Placebo), and Baseline to Week 12 for Arm B (Placebo then Raltegravir).', 'otherNumAtRisk': 52, 'otherNumAffected': 16, 'seriousNumAtRisk': 52, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Blood BILirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14'}, {'term': 'Blood bicarbonate abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14'}, {'term': 'dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'HIV-1 RNA Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Raltegravir (Arm A)', 'description': '400 mg raltegravir (MK-0518) administered twice daily in addition to optimized background regimen (OBR) from entry to Week 12'}, {'id': 'OG001', 'title': 'Placebo (Arm B)', 'description': 'Placebo administered twice daily in addition to OBR from entry until Week 12'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '5.0'}, {'value': '1.7', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '2.3'}]}]}], 'analyses': [{'pValue': '0.546', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is 2-sided and is not adjusted for multiple comparisons', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'At Weeks 10 and 12', 'description': 'HIV-1 RNA level, as measured by single copy assay (units are copies/ml), averaged at weeks 10 and 12. The quantification limit of single copy assay was determined by the volume of plasma tested. When averaging the week 10 and 12 measurements, if one of both measurements were below the single copy assay lower limits, the lower limit of quantification was used to compute the average and the result was treated as below the averaged value.', 'unitOfMeasure': 'copies/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '49 subjects who were on study treatment before week 10 and did not experience virologic failure by week 12'}, {'type': 'SECONDARY', 'title': 'Change in HIV-1 RNA Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Raltegravir (Arm A)', 'description': '400 mg raltegravir (MK-0518) administered twice daily in addition to optimized background regimen (OBR) from entry to Week 12'}, {'id': 'OG001', 'title': 'Placebo (Arm B)', 'description': 'Placebo administered twice daily in addition to OBR from entry until Week 12'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.2', 'groupId': 'OG000', 'lowerLimit': '-1.2', 'upperLimit': '0.2'}, {'value': '-0.1', 'groupId': 'OG001', 'lowerLimit': '-0.6', 'upperLimit': '0.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At pre-entry, entry, weeks 10 and 12', 'description': 'Change in HIV-1 RNA level, as measured by single copy assay (units are copies/ml), from baseline to weeks 10/12 . When averaging the measurements at pre-entry and entry, and at weeks 10 and 12, measurements below the lower limit of quantification (LLQ) were imputed a value of the LLQ divided by 2.', 'unitOfMeasure': 'copies/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were on study treatment and had not experienced virologic failure'}, {'type': 'SECONDARY', 'title': 'Change in Total CD4 Cell Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Raltegravir (Arm A)', 'description': '400 mg raltegravir (MK-0518) administered twice daily in addition to optimized background regimen (OBR) from entry to Week 12'}, {'id': 'OG001', 'title': 'Placebo (Arm B)', 'description': 'Placebo administered twice daily in addition to OBR from entry until Week 12'}], 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000', 'lowerLimit': '-52', 'upperLimit': '80'}, {'value': '-44', 'groupId': 'OG001', 'lowerLimit': '-117', 'upperLimit': '49'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At pre-entry, entry, and week 12', 'description': 'CD4 cell counts were assessed by flow cytometry at pre-entry and entry (the baseline value was the average of the two measurements) and at week 12', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were on study treatment and had not experienced virologic failure'}, {'type': 'SECONDARY', 'title': 'Change in Total CD8 Cell Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Raltegravir (Arm A)', 'description': '400 mg raltegravir (MK-0518) administered twice daily in addition to optimized background regimen (OBR) from entry to Week 12'}, {'id': 'OG001', 'title': 'Placebo (Arm B)', 'description': 'Placebo administered twice daily in addition to OBR from entry until Week 12'}], 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000', 'lowerLimit': '-76', 'upperLimit': '140'}, {'value': '-39', 'groupId': 'OG001', 'lowerLimit': '-152', 'upperLimit': '77'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At pre-entry, entry, and week 12', 'description': 'CD8 cell counts were assessed by flow cytometry at pre-entry and entry (the baseline value was the average of the two measurements) and at week 12', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were on study treatment and had not experienced virologic failure'}, {'type': 'SECONDARY', 'title': 'Change in CD4+/CD38+/HLA-DR+ Percent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Raltegravir (Arm A)', 'description': '400 mg raltegravir (MK-0518) administered twice daily in addition to optimized background regimen (OBR) from entry to Week 12'}, {'id': 'OG001', 'title': 'Placebo (Arm B)', 'description': 'Placebo administered twice daily in addition to OBR from entry until Week 12'}], 'classes': [{'categories': [{'measurements': [{'value': '-1', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '-1', 'upperLimit': '2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At pre-entry, entry, and week 12', 'description': 'Level of CD4+ T-cell activation was determined by measuring the percentage of cells that expressed both the activation marker CD38 and Human leukocyte antigen (HLA)-DR. Levels measured at pre-entry and entry were averaged. Change from baseline to week 12 was defined as CD4+/CD38+/HLA-DR+% at week 12 minus CD4+/CD38+/HLA-DR+% at baseline.', 'unitOfMeasure': '% CD4 cells co-express CD38+ and HLA-DR+', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were on study treatment and had not experienced virologic failure'}, {'type': 'SECONDARY', 'title': 'Change in CD8+/CD38+/HLA-DR+ Percent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Raltegravir (Arm A)', 'description': '400 mg raltegravir (MK-0518) administered twice daily in addition to optimized background regimen (OBR) from entry to Week 12'}, {'id': 'OG001', 'title': 'Placebo (Arm B)', 'description': 'Placebo administered twice daily in addition to OBR from entry until Week 12'}], 'classes': [{'categories': [{'measurements': [{'value': '-1', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '2'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '-2', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At pre-entry, entry, and week 12', 'description': 'Level of CD8+ T-cell activation was determined by measuring the percentage of cells that expressed both the activation marker CD38 and Human leukocyte antigen (HLA)-DR. Levels measured at pre-entry and entry were averaged. Change from baseline to week 12 was defined as CD8+/CD38+/HLA-DR+% at week 12 minus CD8+/CD38+/HLA-DR+% at baseline.', 'unitOfMeasure': '% CD8 cells co-express CD38+ and HLA-DR+', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who stayed on study treatment and had not experienced virologic failures.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced Study Related Grade 2 or Higher Signs/Symptoms, Grade 3 or Higher Laboratory Abnormalities and Clinical Events From First Day of Treatment to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Raltegravir (Arm A)', 'description': '400 mg raltegravir (MK-0518) administered twice daily in addition to optimized background regimen (OBR) from entry to Week 12'}, {'id': 'OG001', 'title': 'Placebo (Arm B)', 'description': 'Placebo administered twice daily in addition to OBR from entry until Week 12'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first day of treatment to week 12', 'description': 'Participant who experienced at least one study related grade 2 or higher signs/symptoms, grade 3 or higher laboratory abnormalities and clinical events that are "possibly", "probably" or "definitely" related to study treatment. DAIDS Toxicity Grading Table (2004) was used for grading.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants on study treatment'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced Study Related Grade 2 or Higher Signs/Symptoms, Grade 3 or Higher Laboratory Abnormalities and Clinical Events From Week 12 to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Arm A)', 'description': 'Placebo administered twice daily in addition to optimized background regimen (OBR) from week 12 to week 24'}, {'id': 'OG001', 'title': 'Raltegravir (Arm B)', 'description': '400 mg raltegravir (MK-0518) administered twice daily in addition to OBR from week 12 to week 24'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From week 12 to week 24', 'description': "Participant who experienced at least one study related grade 2 or higher signs/symptoms, grade 3 or higher laboratory abnormalities and clinical events that are 'possibly', probably', or definitely' related to study treatment. DAIDS Toxicity Grading Table (2004) was used for grading.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Discontinued Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Raltegravir (Arm A)', 'description': '400 mg raltegravir (MK-0518) administered twice daily in addition to optimized background regimen (OBR) from entry to Week 12'}, {'id': 'OG001', 'title': 'Placebo (Arm B)', 'description': 'Placebo administered twice daily in addition to OBR from entry until Week 12'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first day of treatment to week 12', 'description': 'Participants who discontinued randomized study treatment for any reason', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All 53 participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Raltegravir Then Placebo (Arm A)', 'description': '400 mg raltegravir (MK-0518) administered twice daily in addition to optimized background regimen (OBR) from entry to Week 12; halt raltegravir at Week 12 and add placebo twice daily for 12 weeks'}, {'id': 'FG001', 'title': 'Placebo Then Raltegravir (Arm B)', 'description': 'Placebo administered twice daily in addition to OBR from entry until Week 12; halt placebo at Week 12 and add 400 mg raltegravir tablet twice daily for 12 weeks.'}], 'periods': [{'title': 'First Intervention (12 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Unwilling to adhere to study requirement', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Second Intervention (12 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Consent withdraw', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Raltegravir Then Placebo (Arm A)', 'description': '400 mg raltegravir (MK-0518) administered twice daily in addition to optimized background regimen (OBR) from entry to Week 12; halt raltegravir at Week 12 and add placebo twice daily for 12 weeks'}, {'id': 'BG001', 'title': 'Placebo Then Raltegravir (Arm B)', 'description': 'Placebo administered twice daily in addition to OBR from entry until Week 12; halt placebo at Week 12 and add 400 mg raltegravir tablet twice daily for 12 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50', 'spread': '7', 'groupId': 'BG000'}, {'value': '49', 'spread': '11', 'groupId': 'BG001'}, {'value': '49', 'spread': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-02', 'studyFirstSubmitDate': '2007-08-10', 'resultsFirstSubmitDate': '2011-01-25', 'studyFirstSubmitQcDate': '2007-08-10', 'lastUpdatePostDateStruct': {'date': '2021-11-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-05-24', 'studyFirstPostDateStruct': {'date': '2007-08-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-06-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HIV-1 RNA Level', 'timeFrame': 'At Weeks 10 and 12', 'description': 'HIV-1 RNA level, as measured by single copy assay (units are copies/ml), averaged at weeks 10 and 12. The quantification limit of single copy assay was determined by the volume of plasma tested. When averaging the week 10 and 12 measurements, if one of both measurements were below the single copy assay lower limits, the lower limit of quantification was used to compute the average and the result was treated as below the averaged value.'}], 'secondaryOutcomes': [{'measure': 'Change in HIV-1 RNA Level', 'timeFrame': 'At pre-entry, entry, weeks 10 and 12', 'description': 'Change in HIV-1 RNA level, as measured by single copy assay (units are copies/ml), from baseline to weeks 10/12 . When averaging the measurements at pre-entry and entry, and at weeks 10 and 12, measurements below the lower limit of quantification (LLQ) were imputed a value of the LLQ divided by 2.'}, {'measure': 'Change in Total CD4 Cell Count', 'timeFrame': 'At pre-entry, entry, and week 12', 'description': 'CD4 cell counts were assessed by flow cytometry at pre-entry and entry (the baseline value was the average of the two measurements) and at week 12'}, {'measure': 'Change in Total CD8 Cell Count', 'timeFrame': 'At pre-entry, entry, and week 12', 'description': 'CD8 cell counts were assessed by flow cytometry at pre-entry and entry (the baseline value was the average of the two measurements) and at week 12'}, {'measure': 'Change in CD4+/CD38+/HLA-DR+ Percent', 'timeFrame': 'At pre-entry, entry, and week 12', 'description': 'Level of CD4+ T-cell activation was determined by measuring the percentage of cells that expressed both the activation marker CD38 and Human leukocyte antigen (HLA)-DR. Levels measured at pre-entry and entry were averaged. Change from baseline to week 12 was defined as CD4+/CD38+/HLA-DR+% at week 12 minus CD4+/CD38+/HLA-DR+% at baseline.'}, {'measure': 'Change in CD8+/CD38+/HLA-DR+ Percent', 'timeFrame': 'At pre-entry, entry, and week 12', 'description': 'Level of CD8+ T-cell activation was determined by measuring the percentage of cells that expressed both the activation marker CD38 and Human leukocyte antigen (HLA)-DR. Levels measured at pre-entry and entry were averaged. Change from baseline to week 12 was defined as CD8+/CD38+/HLA-DR+% at week 12 minus CD8+/CD38+/HLA-DR+% at baseline.'}, {'measure': 'Number of Participants Who Experienced Study Related Grade 2 or Higher Signs/Symptoms, Grade 3 or Higher Laboratory Abnormalities and Clinical Events From First Day of Treatment to Week 12', 'timeFrame': 'From first day of treatment to week 12', 'description': 'Participant who experienced at least one study related grade 2 or higher signs/symptoms, grade 3 or higher laboratory abnormalities and clinical events that are "possibly", "probably" or "definitely" related to study treatment. DAIDS Toxicity Grading Table (2004) was used for grading.'}, {'measure': 'Number of Participants Who Experienced Study Related Grade 2 or Higher Signs/Symptoms, Grade 3 or Higher Laboratory Abnormalities and Clinical Events From Week 12 to Week 24', 'timeFrame': 'From week 12 to week 24', 'description': "Participant who experienced at least one study related grade 2 or higher signs/symptoms, grade 3 or higher laboratory abnormalities and clinical events that are 'possibly', probably', or definitely' related to study treatment. DAIDS Toxicity Grading Table (2004) was used for grading."}, {'measure': 'Number of Participants Who Discontinued Study Drug', 'timeFrame': 'From first day of treatment to week 12', 'description': 'Participants who discontinued randomized study treatment for any reason'}]}, 'conditionsModule': {'keywords': ['Treatment Experienced'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'pmid': '17434401', 'type': 'BACKGROUND', 'citation': 'Grinsztejn B, Nguyen BY, Katlama C, Gatell JM, Lazzarin A, Vittecoq D, Gonzalez CJ, Chen J, Harvey CM, Isaacs RD; Protocol 005 Team. Safety and efficacy of the HIV-1 integrase inhibitor raltegravir (MK-0518) in treatment-experienced patients with multidrug-resistant virus: a phase II randomised controlled trial. Lancet. 2007 Apr 14;369(9569):1261-1269. doi: 10.1016/S0140-6736(07)60597-2.'}, {'pmid': '17591678', 'type': 'BACKGROUND', 'citation': 'Kassahun K, McIntosh I, Cui D, Hreniuk D, Merschman S, Lasseter K, Azrolan N, Iwamoto M, Wagner JA, Wenning LA. Metabolism and disposition in humans of raltegravir (MK-0518), an anti-AIDS drug targeting the human immunodeficiency virus 1 integrase enzyme. Drug Metab Dispos. 2007 Sep;35(9):1657-63. doi: 10.1124/dmd.107.016196. Epub 2007 Jun 25.'}, {'pmid': '17133211', 'type': 'BACKGROUND', 'citation': 'Markowitz M, Morales-Ramirez JO, Nguyen BY, Kovacs CM, Steigbigel RT, Cooper DA, Liporace R, Schwartz R, Isaacs R, Gilde LR, Wenning L, Zhao J, Teppler H. Antiretroviral activity, pharmacokinetics, and tolerability of MK-0518, a novel inhibitor of HIV-1 integrase, dosed as monotherapy for 10 days in treatment-naive HIV-1-infected individuals. J Acquir Immune Defic Syndr. 2006 Dec 15;43(5):509-15. doi: 10.1097/QAI.0b013e31802b4956.'}, {'pmid': '20711481', 'type': 'RESULT', 'citation': 'Gandhi RT, Zheng L, Bosch RJ, Chan ES, Margolis DM, Read S, Kallungal B, Palmer S, Medvik K, Lederman MM, Alatrakchi N, Jacobson JM, Wiegand A, Kearney M, Coffin JM, Mellors JW, Eron JJ; AIDS Clinical Trials Group A5244 team. The effect of raltegravir intensification on low-level residual viremia in HIV-infected patients on antiretroviral therapy: a randomized controlled trial. PLoS Med. 2010 Aug 10;7(8):e1000321. doi: 10.1371/journal.pmed.1000321.'}, {'pmid': '22083073', 'type': 'DERIVED', 'citation': "Gandhi RT, Coombs RW, Chan ES, Bosch RJ, Zheng L, Margolis DM, Read S, Kallungal B, Chang M, Goecker EA, Wiegand A, Kearney M, Jacobson JM, D'Aquila R, Lederman MM, Mellors JW, Eron JJ; AIDS Clinical Trials Group (ACTG) A5244 Team. No effect of raltegravir intensification on viral replication markers in the blood of HIV-1-infected patients receiving antiretroviral therapy. J Acquir Immune Defic Syndr. 2012 Mar 1;59(3):229-35. doi: 10.1097/QAI.0b013e31823fd1f2."}]}, 'descriptionModule': {'briefSummary': 'Raltegravir (MK-0518) is an HIV-1 integrase inhibitor with potent in vitro activity against HIV-1 strains including those resistant to currently available antiretroviral drugs. The purpose of this study is to assess the effectiveness of raltegravir in further reducing viral load in HIV infected patients that have already achieved viral suppression below the level of detection of standard viral load assays when added to antiretroviral therapy (ART).', 'detailedDescription': "Although ART has reduced the morbidity and mortality from HIV-1 infection, most individuals who stop ART experience rapid viral rebound. Effective ART can suppress viral load to less than 50 copies/ml; however, current treatment regimens cannot completely eliminate the infection. The primary purpose of this study was to assess the ability of the HIV-1 integrase inhibitor, raltegravir, to reduce viral load when added to ART regimens of HIV-1 infected patients who have achieved viral suppression to less than 50 copies/ml.\n\nThe study lasted 24 weeks. Participants were randomly assigned to one of two arms. Participants in Arm A were administered raltegravir in addition to their usual ART regimen from study entry until Week 12. At Week 12, subjects halted raltegravir use and received a placebo until Week 24. Participants in Arm B were administered the placebo in addition to their usual ART regimen from study entry until Week 12. At Week 12, subjects halted the placebo and received raltegravir until Week 24. A real-time polymerase chain reaction (PCR) single copy assay (SCA) capable of detecting 1 copy of HIV RNA was used to assay viral load. The cross-over design allowed assessment of the effect of intensification with raltegravir between the two arms at Weeks 10/12 and every participant enrolled in the study receiving raltegravir for 12 weeks. Primary analysis focused on weeks 10/12 measurement and with no washout period, typical analysis of cross-over design was not intended.\n\nAll participants had scheduled visits at Weeks 0, 2, 4, 10, 12, 14, 16, 22, and 24. A targeted physical exam occurred at all visits. Blood and urine collection occurred at selected visits. A medical/medication assessment occurred at trial entry. Drug dispensing and an adherence questionnaire occurred at some visits. A pregnancy test occurred at select visits. Participants' background ART medications were not provided by the study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV-1 Infection\n* ART for at least 12 months prior to study entry that includes at least two NRTIs and either an NNRTI or a ritonavir-boosted PI\n* No change in ART regimen for at least 3 months prior to study entry\n* CD4 count of 200 or more at screening\n* Viral load below the limit of quantification of an ultrasensitive assay for at least 6 months prior to study entry\n* Viral load less than 50 copies/ml using Roche Amplicor HIV-1 RNA Ultrasensitive assay within 60 days of study entry\n* All viral load assays obtained within 6 months prior to study entry lower than limits of quantification on all tests\n* Pre-ART viral load level greater than 100,000 copies/ml\n* Detectable viral load of 1 copy or more on the screening SCA\n* Available pre-study entry plasma sample for SCA viral load determination\n* Absolute neutrophil count of 750/mm3 or more\n* Hemoglobin of 9 g/dL or more for female subjects and 10 g/dL or more for male subjects\n* Platelet count of 50,000/mm3 or more\n* Calculated creatinine clearance of 30 ml/min or more\n* AST, ALT, and alkaline phosphate less than or equal to 5 x ULN\n* Total bilirubin less than or equal to 2.5 x ULN. If subject is taking indinavir or atazanavir at screening, total bilirubin must be less than or equal to 5 x ULN.\n* Negative serum or urine pregnancy test within 48 hours prior to study entry for females with reproductive potential\n* Willing to use acceptable means of contraception\n\nExclusion Criteria:\n\n* Previous documented virologic failure on an antiretroviral regimen\n* Unstable clinical condition that would preclude the subject from undergoing study procedures\n* Use of immunosuppressive medications within 60 days prior to study entry. Participants using inhaled or nasal steroids are not excluded.\n* Opportunistic infection within 60 days prior to study entry\n* Allergy or sensitivity to components of study drug\n* Active drug or alcohol abuse\n* Serious illness requiring systemic treatment within 60 days prior to study entry\n* Receipt of non-HIV vaccination within 30 days prior to study entry\n* Receipt of any HIV vaccines\n* Plan to change background ART within 24 weeks after study entry\n* Pregnant or breastfeeding'}, 'identificationModule': {'nctId': 'NCT00515827', 'briefTitle': 'Effect of Addition of Raltegravir (MK-0518) to PI- or NNRTI-Based ART Regimens in HIV Infected Subjects With Undetectable Viral Load', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'A Double-Blind, Randomized, Pilot Study to Measure the Effect of Treatment Intensification With a Potent Integrase Inhibitor, Raltegravir (MK-0518), on the Level of Persistent Plasma Viremia Below 50 Copies/ml in Subjects on Protease Inhibitor- or Non-Nucleoside Reverse Transcriptase Inhibitor-Containing Regimens', 'orgStudyIdInfo': {'id': 'A5244'}, 'secondaryIdInfos': [{'id': '10440', 'type': 'REGISTRY', 'domain': 'DAIDS ES'}, {'id': 'ACTG A5244'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Raltegravir then Placebo (Arm A)', 'description': '400 mg raltegravir (MK-0518) administered twice daily in addition to optimized background regimen (OBR) from entry to Week 12; halt raltegravir at Week 12 and add placebo twice daily for 12 weeks', 'interventionNames': ['Drug: Raltegravir (MK-0518)', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo then Raltegravir (Arm B)', 'description': 'Placebo administered twice daily in addition to OBR from entry until Week 12; halt placebo at Week 12 and add 400 mg raltegravir tablet twice daily for 12 weeks', 'interventionNames': ['Drug: Raltegravir (MK-0518)', 'Drug: Placebo']}], 'interventions': [{'name': 'Raltegravir (MK-0518)', 'type': 'DRUG', 'description': '400 mg tablet taken orally twice daily', 'armGroupLabels': ['Placebo then Raltegravir (Arm B)', 'Raltegravir then Placebo (Arm A)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '400 mg placebo tablet taken orally twice daily', 'armGroupLabels': ['Placebo then Raltegravir (Arm B)', 'Raltegravir then Placebo (Arm A)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294-2050', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alabama Therapeutics CRS', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '94304-5350', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford CRS', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Ucsf Aids Crs', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Harbor-UCLA Med. Ctr. CRS', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Hospital CRS', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University CRS', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital ACTG CRS', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Med. Ctr., ACTG CRS', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington U CRS', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10011', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Cornell CRS', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NY Univ. HIV/AIDS CRS', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032-3732', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia P&S CRS', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10037', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Harlem ACTG CRS', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Univ. of Rochester ACTG CRS', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '27514', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Unc Aids Crs', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Univ. Med. Ctr. Adult CRS', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44109', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'MetroHealth CRS', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hosp. of the Univ. of Pennsylvania CRS', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15213-2582', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pitt CRS', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington AIDS CRS', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Rajesh T Gandhi, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Massachusetts General Hospital'}, {'name': 'Joseph J Eron Jr., MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of North Carolina, Chapel Hill'}, {'name': 'John W Mellors, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Pittsburgh Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}