{
  "FullStudy":{
    "Rank":217596,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01519336",
          "OrgStudyIdInfo":{
            "OrgStudyId":"NP28089"
          },
          "Organization":{
            "OrgFullName":"Hoffmann-La Roche",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"A Study of Drug-Drug Interaction Between Darunavir and Danoprevir Administered Together With Low-Dose Ritonavir in Healthy Volunteers",
          "OfficialTitle":"A Study to Evaluate the Potential Drug-Drug Interaction Between Darunavir and Danoprevir When Administered Together With Low-Dose Ritonavir in Healthy Volunteers"
        },
        "StatusModule":{
          "StatusVerifiedDate":"November 2016",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"February 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"March 2012",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"March 2012",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 24, 2012",
          "StudyFirstSubmitQCDate":"January 24, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 26, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"November 1, 2016",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"November 2, 2016",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Hoffmann-La Roche",
            "LeadSponsorClass":"INDUSTRY"
          }
        },
        "OversightModule":{},
        "DescriptionModule":{
          "BriefSummary":"This randomized, open-label, multiple-dose, 2-period crossover study will evaluate potential drug-drug interactions between darunavir and danoprevir when administered together with low-dose ritonavir in healthy volunteers. In Period 1, subjects will be randomized to receive either darunavir or danoprevir together with low-dose ritonavir for 10 days. In Period 2, all subjects will receive darunavir plus danoprevir together with ritonavir for 10 days. Anticipated time on study treatment is 20 days."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Healthy Volunteer"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 1"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Non-Randomized",
            "DesignInterventionModel":"Crossover Assignment",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"40",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"A danoprevir",
                "ArmGroupType":"Active Comparator",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: danoprevir",
                    "Drug: ritonavir"
                  ]
                }
              },{
                "ArmGroupLabel":"B darunavir",
                "ArmGroupType":"Placebo Comparator",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: darunavir",
                    "Drug: ritonavir"
                  ]
                }
              },{
                "ArmGroupLabel":"C danoprevir/darunavir",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: danoprevir",
                    "Drug: darunavir",
                    "Drug: ritonavir"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"danoprevir",
                "InterventionDescription":"100 mg q12h",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "A danoprevir",
                    "C danoprevir/darunavir"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"darunavir",
                "InterventionDescription":"600 mg q12h",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "B darunavir",
                    "C danoprevir/darunavir"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"ritonavir",
                "InterventionDescription":"100 mg q12h",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "A danoprevir",
                    "B darunavir",
                    "C danoprevir/darunavir"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Effect of coadministration of darunavir (DRV), danoprevir (DNV) and ritonavir (RTV) on DRV/DNV/RTV pharmacokinetics: Area under the concentration-time curve (AUC)",
                "PrimaryOutcomeTimeFrame":"approximately 2 months"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Safety: Incidence of adverse events",
                "SecondaryOutcomeTimeFrame":"approximately 2 months"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nHealthy non-smoking male and female adults, 18 - 55 years of age, inclusive\nHealthy status defined by absence of evidence of any active or chronic disease\nMedical history without major, recent, or ongoing pathology\nWeight >/= 55 kg\nBody mass index (BMI) 18.0 - 32.0 kg/m2\nAbility and willingness to abstain from alcohol, xanthine-containing beverages or food (coffee, tea, cola, chocolate, \"energy drinks\") from 72 hours prior to entry in the clinical site center until discharge\nFemales of child-bearing potential and males and their female partners of child-bearing potential must agree to use 2 forms of contraception, one of which must be a barrier method, during the study and for 90 days after the last drug administration. Acceptable barrier forms of contraception are condom and diaphragm; acceptable non-barrier forms of contraception for this study are non-hormonal intrauterine device (IUD) and/or spermicide\n\nExclusion Criteria:\n\nPregnant or lactating females or males with female partners who are pregnant or lactating\nAny history of clinically significant cardiovascular or cerebrovascular disease, hypertension, and/or infections\nPositive test for drugs of abuse at screening or prior to admission to the clinical site during any study period\nPositive for hepatitis B, hepatitis C or HIV infection\nCurrent smokers or subjects who have discontinued smoking less than 6 months prior to first dose of study medication\nUse of hormonal contraceptives within 30 days before the first dose of study medication\nHistory of clinically significant drug-related allergy (such as anaphylaxis) or hepatotoxicity",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"55 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Clinical Trials",
                "OverallOfficialAffiliation":"Hoffmann-La Roche",
                "OverallOfficialRole":"Study Director"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationCity":"Lenexa",
                "LocationState":"Kansas",
                "LocationZip":"66219",
                "LocationCountry":"United States"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"D000019438",
                "InterventionMeshTerm":"Ritonavir"
              },{
                "InterventionMeshId":"D000069454",
                "InterventionMeshTerm":"Darunavir"
              }
            ]
          },
          "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"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M19978",
                "InterventionBrowseLeafName":"Ritonavir",
                "InterventionBrowseLeafAsFound":"Ritonavir",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M423",
                "InterventionBrowseLeafName":"Darunavir",
                "InterventionBrowseLeafAsFound":"Darunavir",
                "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"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"Infe",
                "InterventionBrowseBranchName":"Anti-Infective Agents"
              },{
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              }
            ]
          }
        }
      }
    }
  }
}