{
  "FullStudy":{
    "Rank":217847,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01516060",
          "OrgStudyIdInfo":{
            "OrgStudyId":"Encore1-NC"
          },
          "Organization":{
            "OrgFullName":"Kirby Institute",
            "OrgClass":"OTHER_GOV"
          },
          "BriefTitle":"The Neurocognitive Sub-study of Encore1",
          "OfficialTitle":"The Neurocognitive Sub Study of Encore1:A Randomised, Double‐Blind, Placebo‐Controlled, Clinical Trial to Compare the Safety and Efficacy of Reduced Dose Efavirenz (EFV) With Standard Dose EFV Plus 2N(t)RTI in Antiretroviral‐naïve HIV‐Infected Individuals Over 96 Weeks A Randomised, Double-blind, Placebo-controlled, Clinical Trial to Compare the Safety and Efficacy of Reduced Dose Efavirenz (EFV) With Standard Dose EFV Plus Two Nucleotide Reverse Transcriptase Inhibitors (N(t)RTI) in Antiretroviral-naïve HIV-infected Individuals Over 96 Weeks"
        },
        "StatusModule":{
          "StatusVerifiedDate":"September 2013",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"March 2013",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"March 2013",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 19, 2012",
          "StudyFirstSubmitQCDate":"January 19, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 24, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"September 18, 2013",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"September 19, 2013",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Kirby Institute",
            "LeadSponsorClass":"OTHER_GOV"
          },
          "CollaboratorList":{
            "Collaborator":[
              {
                "CollaboratorName":"The HIV Netherlands Australia Thailand Research Collaboration",
                "CollaboratorClass":"OTHER"
              }
            ]
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"The purpose is to investigate whether HIV and HIV medication can affect certain areas of brain function. This study will look at possible changes in brain function including memory, concentration and thought processes to see if there are any differences between the two doses of efavirenz used in the Encore1 study and also the level of efavirenz in the blood"
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "HIV"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 3"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Screening",
            "DesignMaskingInfo":{
              "DesignMasking":"Double",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Participant",
                  "Investigator"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"71",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Reduced dose Efavirenz arm",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Patient's on main study that was randomised to receive TDF (300mg qd)/FTC (200mg qd) + EFV (400mg qd; 2 x 200mg + 1 x 200mg placebo qd).",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Efavirenz"
                  ]
                }
              },{
                "ArmGroupLabel":"Normal Efavirenz dose arm",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"Patient's on main study randomised to receive tenofovir (TDF) (300mg qd)/emtricitabine (FTC) (200mg qd) + EFV (600mg qd; 3 x 200mg qd)",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Efavirenz"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"Efavirenz",
                "InterventionDescription":"400mg qd; 2 x 200mg",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Reduced dose Efavirenz arm"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"Efavirenz",
                "InterventionDescription":"600mg qd; 3 x 200mg qd",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Normal Efavirenz dose arm"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"The primary endpoint is the comparison between of neurocognitive function in patients initiating sdEFV and 400EFV",
                "PrimaryOutcomeTimeFrame":"48 weeks"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"The association between week 4 plasma EFV levels and change from baseline neurocognitive function to week 4 and 24.",
                "SecondaryOutcomeTimeFrame":"Week 24"
              },{
                "SecondaryOutcomeMeasure":"To assess dynamic changes in neurocognitive function over the total duration of follow-up.",
                "SecondaryOutcomeTimeFrame":"96 weeks"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nAll subjects entering into the main study protocol at participating centres will be eligible to enter this sub-study.\n\nExclusion Criteria:\n\nExisting neurological brain disease\nRecent (<6months ) head injury\nCurrent major depression or psychosis\nCurrent alcohol abuse\nIntended use of recreational drugs during study period\nUncontrolled medical conditions deemed to potentially interfere with cognitive function (e.g. uncontrolled diabetes, pyrexial illness, uraemia etc)",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"16 Years",
          "StdAgeList":{
            "StdAge":[
              "Child",
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Rebekah Puls",
                "OverallOfficialAffiliation":"Kirby Institute",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"HIVNAT Research Collaboration",
                "LocationCity":"Bangkok",
                "LocationCountry":"Thailand"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"C000098320",
                "InterventionMeshTerm":"Efavirenz"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000018894",
                "InterventionAncestorTerm":"Reverse Transcriptase Inhibitors"
              },{
                "InterventionAncestorId":"D000019384",
                "InterventionAncestorTerm":"Nucleic Acid Synthesis Inhibitors"
              },{
                "InterventionAncestorId":"D000004791",
                "InterventionAncestorTerm":"Enzyme Inhibitors"
              },{
                "InterventionAncestorId":"D000045504",
                "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action"
              },{
                "InterventionAncestorId":"D000044966",
                "InterventionAncestorTerm":"Anti-Retroviral Agents"
              },{
                "InterventionAncestorId":"D000000998",
                "InterventionAncestorTerm":"Antiviral Agents"
              },{
                "InterventionAncestorId":"D000000890",
                "InterventionAncestorTerm":"Anti-Infective Agents"
              },{
                "InterventionAncestorId":"D000065688",
                "InterventionAncestorTerm":"Cytochrome P-450 CYP2C9 Inhibitors"
              },{
                "InterventionAncestorId":"D000065607",
                "InterventionAncestorTerm":"Cytochrome P-450 Enzyme Inhibitors"
              },{
                "InterventionAncestorId":"D000065689",
                "InterventionAncestorTerm":"Cytochrome P-450 CYP2C19 Inhibitors"
              },{
                "InterventionAncestorId":"D000065695",
                "InterventionAncestorTerm":"Cytochrome P-450 CYP2B6 Inducers"
              },{
                "InterventionAncestorId":"D000065693",
                "InterventionAncestorTerm":"Cytochrome P-450 Enzyme Inducers"
              },{
                "InterventionAncestorId":"D000065701",
                "InterventionAncestorTerm":"Cytochrome P-450 CYP3A Inducers"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M246264",
                "InterventionBrowseLeafName":"Efavirenz",
                "InterventionBrowseLeafAsFound":"Efavirenz",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M19519",
                "InterventionBrowseLeafName":"Reverse Transcriptase Inhibitors",
                "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":"M29124",
                "InterventionBrowseLeafName":"Cytochrome P-450 Enzyme 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"
              }
            ]
          }
        }
      }
    }
  }
}