{ "FullStudy":{ "Rank":218070, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01513122", "OrgStudyIdInfo":{ "OrgStudyId":"2L body comp sub-study" }, "Organization":{ "OrgFullName":"Kirby Institute", "OrgClass":"OTHER_GOV" }, "BriefTitle":"Bone and Body Comp: A Sub Study of the SECOND-LINE Study", "OfficialTitle":"Bone and Body Comp: A Sub Study of the SECOND-LINE Study" }, "StatusModule":{ "StatusVerifiedDate":"August 2019", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"February 2010" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"September 2012", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"August 2013", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 16, 2012", "StudyFirstSubmitQCDate":"January 19, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 20, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"December 1, 2013", "ResultsFirstSubmitQCDate":"December 1, 2013", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"January 17, 2014", "ResultsFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"August 25, 2019", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"September 4, 2019", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Kirby Institute", "LeadSponsorClass":"OTHER_GOV" } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"The use of anti HIV drugs (ART), and in particular a class of drugs known as nucleoside reverse transcriptase inhibitors (N(t)RTI), has been associated with changes in body fat and in particular loss of peripheral fat in the limbs. Low bone mineral density and osteoporosis are also common in HIV-infected patients. There appears to be some association between ART and bone loss, but this is poorly understood and requires further research. The SECOND-LINE study provides an opportunity to examine if a new anti-HIV drug (raltegravir) can result in greater increase in limb fat than a drug regimen containing N(t)RTI, which is currently standard of care. This study also provides an opportunity to examine if additional bone loss occurs with the second regimen of anti-HIV drugs and whether non-N(t)RTI regimens of ART used in second line therapy result in more or less bone loss than use of other classes of anti-HIV drugs such as protease inhibitors or N(t)RTI combinations.\n\nIt is hypothesized that subjects randomised into Raltegravir arm will demonstrate greater increases in limb fat and smaller reductions in bone density at the proximal femur over 48 weeks than those randomised into the control arm (LPV/r + 2-3N(t)RTIs)." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "HIV" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 4" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"210", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Arm 1. Lopinavir / ritonavir + 2-3N(t)RTI", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3N(t)RTI", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Lopinavir / ritonavir", "Drug: 2-3N(t)RTI" ] } },{ "ArmGroupLabel":"Arm 2. Lopinavir /ritonavir + raltegravir", "ArmGroupType":"Active Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Lopinavir / ritonavir", "Drug: raltegravir" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Lopinavir / ritonavir", "InterventionDescription":"LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Arm 1. Lopinavir / ritonavir + 2-3N(t)RTI", "Arm 2. Lopinavir /ritonavir + raltegravir" ] } },{ "InterventionType":"Drug", "InterventionName":"2-3N(t)RTI", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Arm 1. Lopinavir / ritonavir + 2-3N(t)RTI" ] } },{ "InterventionType":"Drug", "InterventionName":"raltegravir", "InterventionDescription":"raltegravir 400mg 1 tablet twice daily.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Arm 2. Lopinavir /ritonavir + raltegravir" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Mean Bone Mineral Density Changes From Baseline to 48 Weeks as Measured by DXA Scan", "PrimaryOutcomeTimeFrame":"48 weeks" },{ "PrimaryOutcomeMeasure":"Mean Limbs Fat Changes From Baseline to 48 Weeks as Measured by DXA Scan", "PrimaryOutcomeTimeFrame":"48 weeks" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Mean Total Body Fat Changes From Baseline to 48 Weeks as Measured by DXA Scan", "SecondaryOutcomeTimeFrame":"48 weeks" },{ "SecondaryOutcomeMeasure":"Mean Triglycerides Changes From Baseline to 48 Weeks", "SecondaryOutcomeTimeFrame":"48 weeks" },{ "SecondaryOutcomeMeasure":"Mean Total Cholesterol Changes From Baseline to 48 Weeks", "SecondaryOutcomeTimeFrame":"48 weeks" },{ "SecondaryOutcomeMeasure":"Mean Glucose Changes From Baseline to 48 Weeks", "SecondaryOutcomeTimeFrame":"48 weeks" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Second-Line main study identifier: NCT00931463\n\nInclusion Criteria:\n\nHIV-1 positive by licensed diagnostic test\nAged 16 years or older (or minimum age as determined by local regulations or as legal requirements dictate)\nHave received first antiretroviral regimen consisting of an NNRTI plus 2N(t)RTIs for ≥ 24 weeks\nNo change in antiretroviral therapy within 12 weeks prior to screening\nFailed first-line NNRTI + 2N(t)RTI combination therapy according to virological criteria defined by two consecutive (≥7 days apart) HIV RNA results of > 500 copies/mL\nNo prior or current exposure to HIV protease inhibitors and/or HIV integrase inhibitors\nAble to provide written informed consent\n\nExclusion Criteria:\n\nThe following laboratory variables:\n\nabsolute neutrophil count (ANC) < 500 cells/µL\nhemoglobin < 7.0 g/dL\nplatelet count < 50,000 cells/µL\nALT > 5 x ULN\nPregnant or nursing mothers\nParticipants with active viral hepatitis B infection defined by the presence in serum of hepatitis B surface antigen\nUse of immunomodulators within 30 days prior to screening\nUse of any prohibited medications (rifampicin, midazolam, triazolam, cisapride, pimozide, amiodarone, dihydroergotamine, ergotamine, ergonovine, methylergonovine, astemizole, terfenadine, vardenafil, and St. John's wort)\nIntercurrent illness requiring hospitalisation\nActive opportunistic disease not under adequate control in the opinion of the site Principal Investigator\nParticipants with current alcohol or illicit substance abuse that in the opinion of the site Principal Investigator might adversely affect participation in the study\nParticipants deemed by the site Principal Investigator unlikely to be able to remain in follow-up for the protocol-defined period", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"16 Years", "StdAgeList":{ "StdAge":[ "Child", "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Paddy Mallon", "OverallOfficialAffiliation":"Mater Misericordiae University Hospital, Dublin", "OverallOfficialRole":"Principal Investigator" },{ "OverallOfficialName":"Waldo Belloso", "OverallOfficialAffiliation":"Hospital Italiano, Argentina", "OverallOfficialRole":"Principal Investigator" },{ "OverallOfficialName":"Samuel Ferret", "OverallOfficialAffiliation":"Hopital Saint-Louis, France", "OverallOfficialRole":"Principal Investigator" },{ "OverallOfficialName":"Praphan Phanuphak", "OverallOfficialAffiliation":"HIV-NAT Program on AIDS - Thai Red Cross, Bangkok", "OverallOfficialRole":"Principal Investigator" },{ "OverallOfficialName":"Jennifer Hoy", "OverallOfficialAffiliation":"The Alfred", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"CEADI", "LocationCity":"Buenos Aires", "LocationCountry":"Argentina" },{ "LocationFacility":"YRGCare Medical Centre", "LocationCity":"Chennai", "LocationZip":"600113", "LocationCountry":"India" },{ "LocationFacility":"University of Malaya Medical Centre", "LocationCity":"Kuala Lumpur", "LocationZip":"50603", "LocationCountry":"Malaysia" },{ "LocationFacility":"JOSHA Research", "LocationCity":"Bloemfontein", "LocationCountry":"South Africa" },{ "LocationFacility":"Desmond Tutu HIV Foundation", "LocationCity":"Cape Town", "LocationZip":"7925", "LocationCountry":"South Africa" },{ "LocationFacility":"Chris Hani Baragwanath Hospital", "LocationCity":"Soweto", "LocationCountry":"South Africa" },{ "LocationFacility":"HIV-NAT Program on AIDS - Thai Red Cross", "LocationCity":"Bangkok", "LocationZip":"10330", "LocationCountry":"Thailand" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"23921615", "ReferenceType":"result", "ReferenceCitation":"Martin A, Moore C, Mallon PW, Hoy J, Emery S, Belloso W, Phanuphak P, Ferret S, Cooper DA, Boyd MA; Second Line study team. Bone mineral density in HIV participants randomized to raltegravir and lopinavir/ritonavir compared with standard second line therapy. AIDS. 2013 Sep 24;27(15):2403-11. doi: 10.1097/01.aids.0000432534.47217.b4." },{ "ReferencePMID":"24204757", "ReferenceType":"result", "ReferenceCitation":"Martin A, Moore CL, Mallon PW, Hoy JF, Emery S, Belloso WH, Phanuphak P, Ferret S, Cooper DA, Boyd MA; Second-Line Study Team. HIV lipodystrophy in participants randomised to lopinavir/ritonavir (LPV/r) +2-3 nucleoside/nucleotide reverse transcriptase inhibitors (N(t)RTI) or LPV/r + raltegravir as second-line antiretroviral therapy. PLoS One. 2013 Oct 30;8(10):e77138. doi: 10.1371/journal.pone.0077138. eCollection 2013." },{ "ReferencePMID":"27815068", "ReferenceType":"derived", "ReferenceCitation":"Boyd MA, Amin J, Mallon PW, Kumarasamy N, Lombaard J, Wood R, Chetchotisakd P, Phanuphak P, Mohapi L, Azwa I, Belloso WH, Molina JM, Hoy J, Moore CL, Emery S, Cooper DA; SECOND-LINE Study Group. Body composition and metabolic outcomes after 96 weeks of treatment with ritonavir-boosted lopinavir plus either nucleoside or nucleotide reverse transcriptase inhibitors or raltegravir in patients with HIV with virological failure of a standard first-line antiretroviral therapy regimen: a substudy of the randomised, open-label, non-inferiority SECOND-LINE study. Lancet HIV. 2017 Jan;4(1):e13-e20. doi: 10.1016/S2352-3018(16)30189-8. Epub 2016 Nov 1." } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI", "FlowGroupDescription":"Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI" },{ "FlowGroupId":"FG001", "FlowGroupTitle":"Arm 2. Lopinavir /Ritonavir + Raltegravir", "FlowGroupDescription":"Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily." } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"102" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"108" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"91" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"105" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"11" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"3" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI", "BaselineGroupDescription":"Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI" },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"Arm 2. Lopinavir /Ritonavir + Raltegravir", "BaselineGroupDescription":"Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily." },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"102" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"108" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"210" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Median", "BaselineMeasureDispersionType":"Inter-Quartile Range", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"38.6", "BaselineMeasurementSpread":"7.8", "BaselineMeasurementLowerLimit":"34.2", "BaselineMeasurementUpperLimit":"44.1" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"38.9", "BaselineMeasurementSpread":"7.7", "BaselineMeasurementLowerLimit":"32.6", "BaselineMeasurementUpperLimit":"44.4" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"38.8", "BaselineMeasurementSpread":"7.8", "BaselineMeasurementLowerLimit":"32.9", "BaselineMeasurementUpperLimit":"44.2" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"47" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"63" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"110" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"55" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"45" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"100" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Mean Bone Mineral Density Changes From Baseline to 48 Weeks as Measured by DXA Scan", "OutcomeMeasurePopulationDescription":"97 participants reached week 48 in 2-3N(t)RTI arm. 107 reached week 48 in the RAL arm (1 death)", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"percentage change", "OutcomeMeasureTimeFrame":"48 weeks", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI", "OutcomeGroupDescription":"Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Arm 2. Lopinavir /Ritonavir + Raltegravir", "OutcomeGroupDescription":"Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"97" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"107" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-5.2", "OutcomeMeasurementLowerLimit":"-6.7", "OutcomeMeasurementUpperLimit":"-3.8" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-2.9", "OutcomeMeasurementLowerLimit":"-4.3", "OutcomeMeasurementUpperLimit":"-1.5" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Mean Limbs Fat Changes From Baseline to 48 Weeks as Measured by DXA Scan", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"percentage change", "OutcomeMeasureTimeFrame":"48 weeks", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI", "OutcomeGroupDescription":"Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Arm 2. Lopinavir /Ritonavir + Raltegravir", "OutcomeGroupDescription":"Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"94" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"107" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"15.7", "OutcomeMeasurementLowerLimit":"5.3", "OutcomeMeasurementUpperLimit":"25.9" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"21.1", "OutcomeMeasurementLowerLimit":"11.1", "OutcomeMeasurementUpperLimit":"31.1" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Mean Total Body Fat Changes From Baseline to 48 Weeks as Measured by DXA Scan", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"kg", "OutcomeMeasureTimeFrame":"48 weeks", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI", "OutcomeGroupDescription":"Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Arm 2. Lopinavir /Ritonavir + Raltegravir", "OutcomeGroupDescription":"Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"94" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"107" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.4", "OutcomeMeasurementLowerLimit":"0.2", "OutcomeMeasurementUpperLimit":"2.7" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2.1", "OutcomeMeasurementLowerLimit":"0.9", "OutcomeMeasurementUpperLimit":"3.3" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Mean Triglycerides Changes From Baseline to 48 Weeks", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"mmol/L", "OutcomeMeasureTimeFrame":"48 weeks", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI", "OutcomeGroupDescription":"Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Arm 2. Lopinavir /Ritonavir + Raltegravir", "OutcomeGroupDescription":"Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"94" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"105" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.6", "OutcomeMeasurementLowerLimit":"0.3", "OutcomeMeasurementUpperLimit":"0.9" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.8", "OutcomeMeasurementLowerLimit":"0.6", "OutcomeMeasurementUpperLimit":"1.0" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Mean Total Cholesterol Changes From Baseline to 48 Weeks", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"mmol/L", "OutcomeMeasureTimeFrame":"48 weeks", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI", "OutcomeGroupDescription":"Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Arm 2. Lopinavir /Ritonavir + Raltegravir", "OutcomeGroupDescription":"Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"94" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"105" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.4", "OutcomeMeasurementLowerLimit":"0.1", "OutcomeMeasurementUpperLimit":"0.6" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.6", "OutcomeMeasurementLowerLimit":"0.4", "OutcomeMeasurementUpperLimit":"0.9" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Mean Glucose Changes From Baseline to 48 Weeks", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"mmol/L", "OutcomeMeasureTimeFrame":"48 weeks", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI", "OutcomeGroupDescription":"Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Arm 2. Lopinavir /Ritonavir + Raltegravir", "OutcomeGroupDescription":"Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"94" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"105" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.04", "OutcomeMeasurementLowerLimit":"-0.2", "OutcomeMeasurementUpperLimit":"0.2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.1", "OutcomeMeasurementLowerLimit":"-0.4", "OutcomeMeasurementUpperLimit":"0.1" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"0", "EventsDescription":"Adverse Events were not planned to be analyzed for the sub-study and that complete adverse event information is included in the main study report (NCT00931463)", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI", "EventGroupDescription":"Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"0", "EventGroupOtherNumAffected":"0", "EventGroupOtherNumAtRisk":"0" },{ "EventGroupId":"EG001", "EventGroupTitle":"Arm 2. Lopinavir /Ritonavir + Raltegravir", "EventGroupDescription":"Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily.", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"0", "EventGroupOtherNumAffected":"0", "EventGroupOtherNumAtRisk":"0" } ] } }, "MoreInfoModule":{ "CertainAgreement":{ "AgreementPISponsorEmployee":"No", "AgreementRestrictionType":"OTHER", "AgreementRestrictiveAgreement":"Yes", "AgreementOtherDetails":"There is a Clinical Trial Agreement signed with each PI detailing the publication policy and disclosure of study's information, in summary:\n\nThe Institution, its personnel and the Principal Investigator must not Publish or present any aspect of the Study without the prior written approval of the sponsor, except for the purposes of internal training Publications or presentations of results from the Study will follow the agreement's publication/presentation guidelines" }, "PointOfContact":{ "PointOfContactTitle":"Prof Sean Emery", "PointOfContactOrganization":"The Kirby Institute", "PointOfContactEMail":"semery@kirby.unsw.edu.au", "PointOfContactPhone":"+61293850900" } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000019438", "InterventionMeshTerm":"Ritonavir" },{ "InterventionMeshId":"D000061466", "InterventionMeshTerm":"Lopinavir" },{ "InterventionMeshId":"D000068898", "InterventionMeshTerm":"Raltegravir Potassium" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000017320", "InterventionAncestorTerm":"HIV Protease Inhibitors" },{ "InterventionAncestorId":"D000011480", "InterventionAncestorTerm":"Protease Inhibitors" },{ "InterventionAncestorId":"D000004791", "InterventionAncestorTerm":"Enzyme Inhibitors" },{ "InterventionAncestorId":"D000045504", "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action" },{ "InterventionAncestorId":"D000019380", "InterventionAncestorTerm":"Anti-HIV Agents" },{ "InterventionAncestorId":"D000044966", "InterventionAncestorTerm":"Anti-Retroviral Agents" },{ "InterventionAncestorId":"D000000998", "InterventionAncestorTerm":"Antiviral Agents" },{ "InterventionAncestorId":"D000000890", "InterventionAncestorTerm":"Anti-Infective Agents" },{ "InterventionAncestorId":"D000065692", "InterventionAncestorTerm":"Cytochrome P-450 CYP3A Inhibitors" },{ "InterventionAncestorId":"D000065607", "InterventionAncestorTerm":"Cytochrome P-450 Enzyme Inhibitors" },{ "InterventionAncestorId":"D000019428", "InterventionAncestorTerm":"HIV Integrase Inhibitors" },{ "InterventionAncestorId":"D000019429", "InterventionAncestorTerm":"Integrase Inhibitors" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M19978", "InterventionBrowseLeafName":"Ritonavir", "InterventionBrowseLeafAsFound":"Ritonavir", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M28424", "InterventionBrowseLeafName":"Lopinavir", "InterventionBrowseLeafAsFound":"Lopinavir", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M333", "InterventionBrowseLeafName":"Raltegravir Potassium", "InterventionBrowseLeafAsFound":"Raltegravir", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M12926", "InterventionBrowseLeafName":"Protease Inhibitors", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M18192", "InterventionBrowseLeafName":"HIV Protease Inhibitors", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19934", "InterventionBrowseLeafName":"Anti-HIV Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M24015", "InterventionBrowseLeafName":"Anti-Retroviral Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2895", "InterventionBrowseLeafName":"Antiviral Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2795", "InterventionBrowseLeafName":"Anti-Infective Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M29151", "InterventionBrowseLeafName":"Cytochrome P-450 CYP3A Inhibitors", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M29124", "InterventionBrowseLeafName":"Cytochrome P-450 Enzyme Inhibitors", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19970", "InterventionBrowseLeafName":"Integrase Inhibitors", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19969", "InterventionBrowseLeafName":"HIV Integrase Inhibitors", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"Infe", "InterventionBrowseBranchName":"Anti-Infective Agents" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" } ] } }, "ConditionBrowseModule":{ "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M16833", "ConditionBrowseLeafName":"HIV Infections", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M2103", "ConditionBrowseLeafName":"Acquired Immunodeficiency Syndrome", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC02", "ConditionBrowseBranchName":"Viral Diseases" },{ "ConditionBrowseBranchAbbrev":"BC20", "ConditionBrowseBranchName":"Immune System Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" } ] } } } } } }