{ "FullStudy":{ "Rank":217777, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01516970", "OrgStudyIdInfo":{ "OrgStudyId":"CR018349" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"TMC114IFD3004", "SecondaryIdType":"Other Identifier", "SecondaryIdDomain":"Janssen-Cilag G.m.b.H, Germany" },{ "SecondaryId":"2011-001303-13", "SecondaryIdType":"EudraCT Number" } ] }, "Organization":{ "OrgFullName":"Janssen-Cilag G.m.b.H", "OrgClass":"INDUSTRY" }, "BriefTitle":"Human Immunodeficiency Virus (HIV) Postexposure Prophylaxis (PEP) With Darunavir/Ritonavir (DRV/r)", "OfficialTitle":"HIV Postexposure Prophylaxis With Darunavir/r (PEPDar)", "Acronym":"PEPDar" }, "StatusModule":{ "StatusVerifiedDate":"June 2017", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"November 25, 2011", "StartDateType":"Actual" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"August 1, 2013", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"September 28, 2013", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"October 11, 2011", "StudyFirstSubmitQCDate":"January 20, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 25, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"June 20, 2016", "ResultsFirstSubmitQCDate":"August 16, 2016", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"October 11, 2016", "ResultsFirstPostDateType":"Estimate" }, "DispFirstSubmitDate":"June 27, 2014", "DispFirstSubmitQCDate":"June 27, 2014", "DispFirstPostDateStruct":{ "DispFirstPostDate":"June 30, 2014", "DispFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"June 21, 2017", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"July 19, 2017", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Janssen-Cilag G.m.b.H", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No", "IsFDARegulatedDevice":"No" }, "DescriptionModule":{ "BriefSummary":"The primary purpose of this study is to assess the rate of early discontinuation from randomized Human Immunodeficiency Virus (HIV) Postexposure Prophylaxis (PEP) for any reason other than confirmation of the negative HIV infection status of the index person in patients receiving HIV PEP for at least 28 and a maximum of 30 days.", "DetailedDescription":"This is a randomized (study medication assigned by chance), open-label (all people involved know the identity of the intervention), active-controlled (patients are assigned to either a recognized effective treatment or the study medication), parallel-group (each treatment group will be treated at the same time), multicenter study comparing DRV/r PEP (DRV/r administered with 2 NRTIs selected at the discretion of the investigator) to standard of care PEP (as per German-Austrian guidelines) in patients at risk of HIV infection due to HIV exposure through occupational injury and non-occupational exposure. This study consists of screening period, treatment period and a follow up period. HIV PEP will be administered for a total of at least 28 days and maximum of 30 days during treatment period, including any prestudy HIV PEP initiated before screening. Approximately 318 patients will be screened and enrolled to ensure that at least 131 patients are randomly assigned to receive DRV/r PEP or standard of care PEP. Safety will be evaluated during the entire study period. Data relating to a patient's functional impairment in conjunction with HIV PEP will be collected on Day 1 as baseline data, and further on Days 14 and 28 as well as at Month 3." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Human Immunodeficiency Virus (HIV)" ] }, "KeywordList":{ "Keyword":[ "Human Immunodeficiency Virus (HIV) Post exposure prophylaxis", "DRV/r", "Occupational injury", "Non-occupational exposure", "Prezista", "Darunavir/r" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 3" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"312", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"DRV/r with 2 NRTIs", "ArmGroupType":"Experimental", "ArmGroupDescription":"DRV/r 800/100 mg q.d. with 2 NRTIs: darunavir (800 mg) in combination with low-dose ritonavir (100 mg) administered once a day for at least 28 days and a maximum of 30 days along with 2 nucleoside/nucleotide analogue reverse transcriptase inhibitors (NRTIs).", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Darunavir/Ritonavir (DRV/r)", "Drug: NRTIs" ] } },{ "ArmGroupLabel":"Comparator standard of care HIV PEP", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"Comparator standard of care HIV PEP (as per German-Austrian Guidelines): Administration of the standard of care HIV PEP (postexposure prophylaxis) consisting of 2 NRTIs plus third partner.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Lopinavir in fixed combination with Ritonavir", "Drug: Zidovudine", "Drug: NRTIs", "Drug: Efavirenz" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Darunavir/Ritonavir (DRV/r)", "InterventionDescription":"Darunavir (DRV) type=exact number, unit=mg, number=800, form=tablet, route=oral use. Tablet is taken once a day, for 28 days; Ritonavir (r) type=exact number, unit=mg, number=100, form=tablet, route=oral use. Tablet is taken once a day, for at least 28 days and a maximum of 30 days.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "DRV/r with 2 NRTIs" ] } },{ "InterventionType":"Drug", "InterventionName":"Lopinavir in fixed combination with Ritonavir", "InterventionDescription":"type=exact number, unit=mg, number=400/100, form=tablet, route=oral use. Tablet is taken once or twice a day, for at least 28 days and a maximum of 30 days.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Comparator standard of care HIV PEP" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Kaletra" ] } },{ "InterventionType":"Drug", "InterventionName":"Zidovudine", "InterventionDescription":"type=exact number, unit=mg, number=250, form=tablet, route=oral use. Tablet is taken twice a day, for at least 28 days and a maximum of 30 days.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Comparator standard of care HIV PEP" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Retrovir" ] } },{ "InterventionType":"Drug", "InterventionName":"NRTIs", "InterventionDescription":"The NRTIs (including tenofovir/emtricitabine [Truvada], lamivudine/zidovudine [Combivir]) will be administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Comparator standard of care HIV PEP", "DRV/r with 2 NRTIs" ] } },{ "InterventionType":"Drug", "InterventionName":"Efavirenz", "InterventionDescription":"type=exact number, unit=mg, number=600, form=tablet, route=oral use. Tablet is taken once a day, for at least 28 days and a maximum of 30 days.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Comparator standard of care HIV PEP" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Sustiva" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Number of Participants With Early Discontinuation From Randomized Human Immunodeficiency Virus Postexposure Prophylaxis (HIV PEP)", "PrimaryOutcomeDescription":"Number of participants with early discontinuation from randomized HIV PEP for any reason other than confirmation of the negative HIV infection status of the index person in participants receiving HIV PEP for at least 28 days and a maximum of 30 days was assessed. Per protocol (PP) population included all participants in modified intention-to-treat (mITT [defined as all participants who were assigned to receive randomized HIV PEP and were not discontinued due to confirmation of the negative HIV infection status of the index person]) excluding participants with: No indication for HIV PEP; Initiation of PEP >72 hours after injury; Discontinuation of HIV PEP due to confirmation of HIV negative status of index person and if index person bears resistant virus against HIV PEP components prescribed; incorrect HIV PEP; no intake of medication.", "PrimaryOutcomeTimeFrame":"Up to 30 days" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Number of Participants With Treatment-Emergent Adverse Events (TEAEs)", "SecondaryOutcomeDescription":"An adverse event (AE) is defined to be non-treatment-emergent if the onset date of the AE was clearly before the date of first HIV PEP administration, otherwise it is considered treatment-emergent.", "SecondaryOutcomeTimeFrame":"Up to Month 3" },{ "SecondaryOutcomeMeasure":"Worst Sheehan Disability Scale (SDS) Score for the Safety Population", "SecondaryOutcomeDescription":"The Sheehan Disability Scale (SDS) assesses functional impairment in 3 inter-related domains: work/school, social and family life, using a rating scale for each item ranging from 0 (not at all) to 10 (extremely).", "SecondaryOutcomeTimeFrame":"Month 3" },{ "SecondaryOutcomeMeasure":"Percentage of Participants Who Developed Detectable HIV Antibodies", "SecondaryOutcomeDescription":"Seroconversion rate of HIV antibodies while receiving HIV PEP evaluated as the percentage of participants who developed detectable HIV antibodies (defined as positive) and percentage of participants who had not developed detectable HIV antibodies (defined as negative). Per protocol (PP) population included all participants in mITT (defined as all participants who were assigned to receive randomized HIV PEP and were not discontinued due to confirmation of the negative HIV infection status of the index person) excluding participants with: No indication for HIV PEP; Initiation of PEP >72 hours after injury; Discontinuation of HIV PEP due to confirmation of HIV negative status of index person and if index person bears resistant virus against HIV PEP components prescribed; incorrect HIV PEP; no intake of medication.", "SecondaryOutcomeTimeFrame":"At Month 3" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nOccupational injury and non-occupational exposure with documented human immunodeficiency virus (HIV) exposure, or potential for HIV exposure\nIndication for HIV postexposure prophylaxis (PEP), as determined by the treating physician and/or the investigator\nWomen must be: postmenopausal (for at least 2 years), surgically sterile, using oral contraceptives\nWilling to continue HIV PEP for 28 days\n\nExclusion Criteria:\n\nPositive HIV rapid test\nHistory of liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastro intestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances\nPregnant or breast-feeding\nAny condition that, in the opinion of the investigator, would compromise the well-being of the participant or the study or prevent the participant from meeting or performing study requirements", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Janssen-Cilag G.m.b.H, Germany Clinical Trial", "OverallOfficialAffiliation":"Janssen-Cilag G.m.b.H", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationCity":"Berlin", "LocationCountry":"Germany" },{ "LocationCity":"Bonn", "LocationCountry":"Germany" },{ "LocationCity":"Dortmund", "LocationCountry":"Germany" },{ "LocationCity":"Dresden", "LocationCountry":"Germany" },{ "LocationCity":"Düsseldorf", "LocationCountry":"Germany" },{ "LocationCity":"Erlangen", "LocationCountry":"Germany" },{ "LocationCity":"Frankfurt", "LocationCountry":"Germany" },{ "LocationCity":"Freiburg", "LocationCountry":"Germany" },{ "LocationCity":"Hamburg", "LocationCountry":"Germany" },{ "LocationCity":"Köln", "LocationCountry":"Germany" },{ "LocationCity":"Magdeburg", "LocationCountry":"Germany" },{ "LocationCity":"Mainz", "LocationCountry":"Germany" },{ "LocationCity":"Mannheim", "LocationCountry":"Germany" },{ "LocationCity":"München", "LocationCountry":"Germany" },{ "LocationCity":"Regensburg", "LocationCountry":"Germany" },{ "LocationCity":"Stuttgart", "LocationCountry":"Germany" },{ "LocationCity":"Ulm", "LocationCountry":"Germany" } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Darunavir/Ritonavir Postexposure Prophylaxis (DRV/r PEP)", "FlowGroupDescription":"Darunavir (800 milligram [mg]) in combination with low-dose ritonavir (100 mg) administered once a day for at least 28 days and a maximum of 30 days along with 2 nucleoside/nucleotide analogue reverse transcriptase inhibitors (NRTIs). The NRTIs (including tenofovir/emtricitabine [Truvada] was administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator." },{ "FlowGroupId":"FG001", "FlowGroupTitle":"Standard of Care Postexposure Prophylaxis (SOCPEP)", "FlowGroupDescription":"Standard of care human immunodeficiency virus (HIV) PEP (as per German-Austrian Guidelines): Administration of the standard of care HIV PEP (postexposure prophylaxis) consisting of 2 NRTIs plus third partner. Lopinavir in combination with low-dose ritonavir (LPV/r) [Kaletra] was combined with following NRTIs: TDF (tenofovir)/ FTC (emtricitabine) [Truvada], AZT (zidovudine)/3TC (lamivudine) [Combivir]) and ABC (Abacavir)/ 3TC (Lamivudine) administered as per the individual SmPCs at the discretion of either the treating physician or Investigator." } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"159" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"153" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"141" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"132" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"18" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"21" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Lost to Follow-up", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"7" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"8" } ] } },{ "FlowDropWithdrawType":"Adverse Event", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"5" } ] } },{ "FlowDropWithdrawType":"Withdrawal by Subject", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"1" } ] } },{ "FlowDropWithdrawType":"Other", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"9" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"7" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselinePopulationDescription":"The safety population included all participants who received at least 1 dose of randomized HIV PEP.", "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Darunavir/Ritonavir Postexposure Prophylaxis (DRV/r PEP)", "BaselineGroupDescription":"Darunavir (800 milligram [mg]) in combination with low-dose ritonavir (100 mg) administered once a day for at least 28 days and a maximum of 30 days along with 2 nucleoside/nucleotide analogue reverse transcriptase inhibitors (NRTIs). The NRTIs (including tenofovir/emtricitabine [Truvada] was administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator." },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"Standard of Care Postexposure Prophylaxis (SOCPEP)", "BaselineGroupDescription":"Standard of care human immunodeficiency virus (HIV) PEP (as per German-Austrian Guidelines): Administration of the standard of care HIV PEP (postexposure prophylaxis) consisting of 2 NRTIs plus third partner. Lopinavir in combination with low-dose ritonavir (LPV/r) [Kaletra] was combined with following NRTIs: TDF (tenofovir)/ FTC (emtricitabine) [Truvada], AZT (zidovudine)/3TC (lamivudine) [Combivir]) and ABC (Abacavir)/ 3TC (Lamivudine) administered as per the individual SmPCs at the discretion of either the treating physician or Investigator." },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"159" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"153" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"312" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"34.2", "BaselineMeasurementSpread":"9.2" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"32.3", "BaselineMeasurementSpread":"9.3" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"33.3", "BaselineMeasurementSpread":"9.3" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"28" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"28" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"56" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"131" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"125" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"256" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Number of Participants With Early Discontinuation From Randomized Human Immunodeficiency Virus Postexposure Prophylaxis (HIV PEP)", "OutcomeMeasureDescription":"Number of participants with early discontinuation from randomized HIV PEP for any reason other than confirmation of the negative HIV infection status of the index person in participants receiving HIV PEP for at least 28 days and a maximum of 30 days was assessed. Per protocol (PP) population included all participants in modified intention-to-treat (mITT [defined as all participants who were assigned to receive randomized HIV PEP and were not discontinued due to confirmation of the negative HIV infection status of the index person]) excluding participants with: No indication for HIV PEP; Initiation of PEP >72 hours after injury; Discontinuation of HIV PEP due to confirmation of HIV negative status of index person and if index person bears resistant virus against HIV PEP components prescribed; incorrect HIV PEP; no intake of medication.", "OutcomeMeasurePopulationDescription":"Analysis was performed on PP population.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"participants", "OutcomeMeasureTimeFrame":"Up to 30 days", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Darunavir/Ritonavir Postexposure Prophylaxis (DRV/r PEP)", "OutcomeGroupDescription":"Darunavir (800 milligram [mg]) in combination with low-dose ritonavir (100 mg) administered once a day for at least 28 days and a maximum of 30 days along with 2 nucleoside/nucleotide analogue reverse transcriptase inhibitors (NRTIs). The NRTIs (including tenofovir/emtricitabine [Truvada] was administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Standard of Care Postexposure Prophylaxis (SOCPEP)", "OutcomeGroupDescription":"Standard of care human immunodeficiency virus (HIV) PEP (as per German-Austrian Guidelines): Administration of the standard of care HIV PEP (postexposure prophylaxis) consisting of 2 NRTIs plus third partner. Lopinavir in combination with low-dose ritonavir (LPV/r) [Kaletra] was combined with following NRTIs: TDF (tenofovir)/ FTC (emtricitabine) [Truvada], AZT (zidovudine)/3TC (lamivudine) [Combivir]) and ABC (Abacavir)/ 3TC (Lamivudine) administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"155" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"150" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"10", "OutcomeMeasurementLowerLimit":"3.5", "OutcomeMeasurementUpperLimit":"11.5" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"15", "OutcomeMeasurementLowerLimit":"6.2", "OutcomeMeasurementUpperLimit":"15.8" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.2434", "OutcomeAnalysisPValueComment":"The discontinuation rates were compared with a statistical test (Cochran-Mantel-Haenszel [CMH]-Test) with p-value: 0.2434", "OutcomeAnalysisStatisticalMethod":"Cochran-Mantel-Haenszel" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Number of Participants With Treatment-Emergent Adverse Events (TEAEs)", "OutcomeMeasureDescription":"An adverse event (AE) is defined to be non-treatment-emergent if the onset date of the AE was clearly before the date of first HIV PEP administration, otherwise it is considered treatment-emergent.", "OutcomeMeasurePopulationDescription":"The safety population included all participants who received at least 1 dose of randomized HIV PEP.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"participants", "OutcomeMeasureTimeFrame":"Up to Month 3", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Darunavir/Ritonavir Postexposure Prophylaxis (DRV/r PEP)", "OutcomeGroupDescription":"Darunavir (800 milligram [mg]) in combination with low-dose ritonavir (100 mg) administered once a day for at least 28 days and a maximum of 30 days along with 2 nucleoside/nucleotide analogue reverse transcriptase inhibitors (NRTIs). The NRTIs (including tenofovir/emtricitabine [Truvada] was administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Standard of Care Postexposure Prophylaxis (SOCPEP)", "OutcomeGroupDescription":"Standard of care human immunodeficiency virus (HIV) PEP (as per German-Austrian Guidelines): Administration of the standard of care HIV PEP (postexposure prophylaxis) consisting of 2 NRTIs plus third partner. Lopinavir in combination with low-dose ritonavir (LPV/r) [Kaletra] was combined with following NRTIs: TDF (tenofovir)/ FTC (emtricitabine) [Truvada], AZT (zidovudine)/3TC (lamivudine) [Combivir]) and ABC (Abacavir)/ 3TC (Lamivudine) administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"159" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"153" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"131" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"125" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.8839", "OutcomeAnalysisPValueComment":"The percentage of participants with TEAEs were compared with a statistical test (Fisher's Exact Test) with p-value: 0.8839.", "OutcomeAnalysisStatisticalMethod":"Fisher Exact" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Worst Sheehan Disability Scale (SDS) Score for the Safety Population", "OutcomeMeasureDescription":"The Sheehan Disability Scale (SDS) assesses functional impairment in 3 inter-related domains: work/school, social and family life, using a rating scale for each item ranging from 0 (not at all) to 10 (extremely).", "OutcomeMeasurePopulationDescription":"The safety population included all participants who received at least 1 dose of randomized HIV PEP.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"units on a scale", "OutcomeMeasureTimeFrame":"Month 3", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Darunavir/Ritonavir Postexposure Prophylaxis (DRV/r PEP)", "OutcomeGroupDescription":"Darunavir (800 milligram [mg]) in combination with low-dose ritonavir (100 mg) administered once a day for at least 28 days and a maximum of 30 days along with 2 nucleoside/nucleotide analogue reverse transcriptase inhibitors (NRTIs). The NRTIs (including tenofovir/emtricitabine [Truvada] was administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Standard of Care Postexposure Prophylaxis (SOCPEP)", "OutcomeGroupDescription":"Standard of care human immunodeficiency virus (HIV) PEP (as per German-Austrian Guidelines): Administration of the standard of care HIV PEP (postexposure prophylaxis) consisting of 2 NRTIs plus third partner. Lopinavir in combination with low-dose ritonavir (LPV/r) [Kaletra] was combined with following NRTIs: TDF (tenofovir)/ FTC (emtricitabine) [Truvada], AZT (zidovudine)/3TC (lamivudine) [Combivir]) and ABC (Abacavir)/ 3TC (Lamivudine) administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"159" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"153" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Impairment in work/school/studies", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2.566", "OutcomeMeasurementSpread":"2.775" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3.503", "OutcomeMeasurementSpread":"2.940" } ] } } ] } },{ "OutcomeClassTitle":"Impairment in social life", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2.465", "OutcomeMeasurementSpread":"2.594" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3.464", "OutcomeMeasurementSpread":"2.786" } ] } } ] } },{ "OutcomeClassTitle":"Impairment in family life", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2.226", "OutcomeMeasurementSpread":"2.624" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2.954", "OutcomeMeasurementSpread":"2.713" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants Who Developed Detectable HIV Antibodies", "OutcomeMeasureDescription":"Seroconversion rate of HIV antibodies while receiving HIV PEP evaluated as the percentage of participants who developed detectable HIV antibodies (defined as positive) and percentage of participants who had not developed detectable HIV antibodies (defined as negative). Per protocol (PP) population included all participants in mITT (defined as all participants who were assigned to receive randomized HIV PEP and were not discontinued due to confirmation of the negative HIV infection status of the index person) excluding participants with: No indication for HIV PEP; Initiation of PEP >72 hours after injury; Discontinuation of HIV PEP due to confirmation of HIV negative status of index person and if index person bears resistant virus against HIV PEP components prescribed; incorrect HIV PEP; no intake of medication.", "OutcomeMeasurePopulationDescription":"Analysis was performed on PP population. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"At Month 3", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Darunavir/Ritonavir Postexposure Prophylaxis (DRV/r PEP)", "OutcomeGroupDescription":"Darunavir (800 milligram [mg]) in combination with low-dose ritonavir (100 mg) administered once a day for at least 28 days and a maximum of 30 days along with 2 nucleoside/nucleotide analogue reverse transcriptase inhibitors (NRTIs). The NRTIs (including tenofovir/emtricitabine [Truvada] was administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Standard of Care Postexposure Prophylaxis (SOCPEP)", "OutcomeGroupDescription":"Standard of care human immunodeficiency virus (HIV) PEP (as per German-Austrian Guidelines): Administration of the standard of care HIV PEP (postexposure prophylaxis) consisting of 2 NRTIs plus third partner. Lopinavir in combination with low-dose ritonavir (LPV/r) [Kaletra] was combined with following NRTIs: TDF (tenofovir)/ FTC (emtricitabine) [Truvada], AZT (zidovudine)/3TC (lamivudine) [Combivir]) and ABC (Abacavir)/ 3TC (Lamivudine) administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"138" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"133" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Negative", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"99.3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"100" } ] } } ] } },{ "OutcomeClassTitle":"Positive", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.7" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"2", "EventsTimeFrame":"Up to Month 3", "EventsDescription":"The safety population included all participants who received at least 1 dose of randomized HIV PEP.", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Darunavir/Ritonavir Postexposure Prophylaxis (DRV/r PEP)", "EventGroupDescription":"Darunavir (800 milligram [mg]) in combination with low-dose ritonavir (100 mg) administered once a day for at least 28 days and a maximum of 30 days along with 2 nucleoside/nucleotide analogue reverse transcriptase inhibitors (NRTIs). The NRTIs (including tenofovir/emtricitabine [Truvada] was administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.", "EventGroupSeriousNumAffected":"1", "EventGroupSeriousNumAtRisk":"159", "EventGroupOtherNumAffected":"96", "EventGroupOtherNumAtRisk":"159" },{ "EventGroupId":"EG001", "EventGroupTitle":"Standard of Care Postexposure Prophylaxis (SOCPEP)", "EventGroupDescription":"Standard of care human immunodeficiency virus (HIV) PEP (as per German-Austrian Guidelines): Administration of the standard of care HIV PEP (postexposure prophylaxis) consisting of 2 NRTIs plus third partner. Lopinavir in combination with low-dose ritonavir (LPV/r) [Kaletra] was combined with following NRTIs: TDF (tenofovir)/ FTC (emtricitabine) [Truvada], AZT (zidovudine)/3TC (lamivudine) [Combivir]) and ABC (Abacavir)/ 3TC (Lamivudine) administered as per the individual SmPCs at the discretion of either the treating physician or Investigator.", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"153", "EventGroupOtherNumAffected":"111", "EventGroupOtherNumAtRisk":"153" } ] }, "SeriousEventList":{ "SeriousEvent":[ { "SeriousEventTerm":"Depression", "SeriousEventOrganSystem":"Psychiatric disorders", "SeriousEventSourceVocabulary":"MedDRA version 16.0", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventNotes":"The only serious adverse event observed in the DRV/r arm was a hospitalization due to an unrelated depression.", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"159" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"153" } ] } } ] }, "OtherEventList":{ "OtherEvent":[ { "OtherEventTerm":"Dizziness", "OtherEventOrganSystem":"Nervous system disorders", "OtherEventSourceVocabulary":"MedDRA version 16.0", "OtherEventAssessmentType":"Non-systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"6", "OtherEventStatsNumAtRisk":"159" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"153" } ] } },{ "OtherEventTerm":"Dysgeusia", "OtherEventOrganSystem":"Nervous system disorders", "OtherEventSourceVocabulary":"MedDRA version 16.0", "OtherEventAssessmentType":"Non-systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"159" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"5", "OtherEventStatsNumAtRisk":"153" } ] } },{ "OtherEventTerm":"Headache", "OtherEventOrganSystem":"Nervous system disorders", "OtherEventSourceVocabulary":"MedDRA version 16.0", "OtherEventAssessmentType":"Non-systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"19", "OtherEventStatsNumAtRisk":"159" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"8", "OtherEventStatsNumAtRisk":"153" } ] } },{ "OtherEventTerm":"Asthenia", "OtherEventOrganSystem":"General disorders", "OtherEventSourceVocabulary":"MedDRA version 16.0", "OtherEventAssessmentType":"Non-systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"5", "OtherEventStatsNumAtRisk":"159" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"153" } ] } },{ "OtherEventTerm":"Fatigue", "OtherEventOrganSystem":"General disorders", "OtherEventSourceVocabulary":"MedDRA version 16.0", "OtherEventAssessmentType":"Non-systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"21", "OtherEventStatsNumAtRisk":"159" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"28", "OtherEventStatsNumAtRisk":"153" } ] } },{ "OtherEventTerm":"Sleep Disorder", "OtherEventOrganSystem":"Psychiatric disorders", "OtherEventSourceVocabulary":"MedDRA version 16.0", "OtherEventAssessmentType":"Non-systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"159" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"6", "OtherEventStatsNumAtRisk":"153" } ] } },{ "OtherEventTerm":"Abdominal Pain Upper", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventSourceVocabulary":"MedDRA version 16.0", "OtherEventAssessmentType":"Non-systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"14", "OtherEventStatsNumAtRisk":"159" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"11", "OtherEventStatsNumAtRisk":"153" } ] } },{ "OtherEventTerm":"Diarrhoea", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventSourceVocabulary":"MedDRA version 16.0", "OtherEventAssessmentType":"Non-systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"45", "OtherEventStatsNumAtRisk":"159" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"76", "OtherEventStatsNumAtRisk":"153" } ] } },{ "OtherEventTerm":"Flatulence", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventSourceVocabulary":"MedDRA version 16.0", "OtherEventAssessmentType":"Non-systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"5", "OtherEventStatsNumAtRisk":"159" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"11", "OtherEventStatsNumAtRisk":"153" } ] } },{ "OtherEventTerm":"Nausea", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventSourceVocabulary":"MedDRA version 16.0", "OtherEventAssessmentType":"Non-systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"24", "OtherEventStatsNumAtRisk":"159" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"41", "OtherEventStatsNumAtRisk":"153" } ] } },{ "OtherEventTerm":"Vomiting", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventSourceVocabulary":"MedDRA version 16.0", "OtherEventAssessmentType":"Non-systematic Assessment", "OtherEventStatsList":{ 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