Nctid:
NCT00000758
Payload:
{"FullStudy"=>{"Rank"=>474140, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"December 01, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000002578", "ConditionMeshTerm"=>"Uterine Cervical Dysplasia"}, {"ConditionMeshId"=>"D000006965", "ConditionMeshTerm"=>"Hyperplasia"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000091662", "ConditionAncestorTerm"=>"Genital Diseases"}, {"ConditionAncestorId"=>"D000091642", "ConditionAncestorTerm"=>"Urogenital Diseases"}, {"ConditionAncestorId"=>"D000010335", "ConditionAncestorTerm"=>"Pathologic Processes"}, {"ConditionAncestorId"=>"D000011230", "ConditionAncestorTerm"=>"Precancerous Conditions"}, {"ConditionAncestorId"=>"D000009369", "ConditionAncestorTerm"=>"Neoplasms"}, {"ConditionAncestorId"=>"D000002577", "ConditionAncestorTerm"=>"Uterine Cervical Diseases"}, {"ConditionAncestorId"=>"D000014591", "ConditionAncestorTerm"=>"Uterine Diseases"}, {"ConditionAncestorId"=>"D000005831", "ConditionAncestorTerm"=>"Genital Diseases, Female"}, {"ConditionAncestorId"=>"D000052776", "ConditionAncestorTerm"=>"Female Urogenital Diseases"}, {"ConditionAncestorId"=>"D000005261", "ConditionAncestorTerm"=>"Female Urogenital Diseases and Pregnancy Complications"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M9973", "ConditionBrowseLeafName"=>"Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M6058", "ConditionBrowseLeafName"=>"Communicable Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M16045", "ConditionBrowseLeafName"=>"Syndrome", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M17940", "ConditionBrowseLeafName"=>"HIV Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M9889", "ConditionBrowseLeafName"=>"Immunologic Deficiency Syndromes", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M5516", "ConditionBrowseLeafName"=>"Uterine Cervical Dysplasia", "ConditionBrowseLeafAsFound"=>"Cervical Dysplasia", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M3212", "ConditionBrowseLeafName"=>"Acquired Immunodeficiency Syndrome", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M5515", "ConditionBrowseLeafName"=>"Uterine Cervical Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M3425", "ConditionBrowseLeafName"=>"AIDS-Related Complex", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M9706", "ConditionBrowseLeafName"=>"Hyperplasia", "ConditionBrowseLeafAsFound"=>"Dysplasia", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M2877", "ConditionBrowseLeafName"=>"Genital Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M2876", "ConditionBrowseLeafName"=>"Urogenital Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M13801", "ConditionBrowseLeafName"=>"Precancerous Conditions", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M17029", "ConditionBrowseLeafName"=>"Uterine Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M8633", "ConditionBrowseLeafName"=>"Genital Diseases, Female", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M26783", "ConditionBrowseLeafName"=>"Female Urogenital Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M13817", "ConditionBrowseLeafName"=>"Pregnancy Complications", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M8089", "ConditionBrowseLeafName"=>"Female Urogenital Diseases and Pregnancy Complications", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"T1074", "ConditionBrowseLeafName"=>"Cervical Intraepithelial Neoplasia", "ConditionBrowseLeafAsFound"=>"Cervical Dysplasia", "ConditionBrowseLeafRelevance"=>"high"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Infections", "ConditionBrowseBranchAbbrev"=>"BC01"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Symptoms and General Pathology", "ConditionBrowseBranchAbbrev"=>"BC23"}, {"ConditionBrowseBranchName"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "ConditionBrowseBranchAbbrev"=>"BXS"}, {"ConditionBrowseBranchName"=>"Immune System Diseases", "ConditionBrowseBranchAbbrev"=>"BC20"}, {"ConditionBrowseBranchName"=>"Neoplasms", "ConditionBrowseBranchAbbrev"=>"BC04"}, {"ConditionBrowseBranchName"=>"Rare Diseases", "ConditionBrowseBranchAbbrev"=>"Rare"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"D000005472", "InterventionMeshTerm"=>"Fluorouracil"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000000963", "InterventionAncestorTerm"=>"Antimetabolites"}, {"InterventionAncestorId"=>"D000045504", "InterventionAncestorTerm"=>"Molecular Mechanisms of Pharmacological Action"}, {"InterventionAncestorId"=>"D000000964", "InterventionAncestorTerm"=>"Antimetabolites, Antineoplastic"}, {"InterventionAncestorId"=>"D000000970", "InterventionAncestorTerm"=>"Antineoplastic Agents"}, {"InterventionAncestorId"=>"D000007166", "InterventionAncestorTerm"=>"Immunosuppressive Agents"}, {"InterventionAncestorId"=>"D000007155", "InterventionAncestorTerm"=>"Immunologic Factors"}, {"InterventionAncestorId"=>"D000045505", "InterventionAncestorTerm"=>"Physiological Effects of Drugs"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M8290", "InterventionBrowseLeafName"=>"Fluorouracil", "InterventionBrowseLeafAsFound"=>"Ultrasound", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M3971", "InterventionBrowseLeafName"=>"Antimetabolites", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M9902", "InterventionBrowseLeafName"=>"Immunosuppressive Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M9891", "InterventionBrowseLeafName"=>"Immunologic Factors", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Antineoplastic Agents", "InterventionBrowseBranchAbbrev"=>"ANeo"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 3"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignPrimaryPurpose"=>"Prevention", "DesignInterventionModel"=>"Parallel Assignment"}, "EnrollmentInfo"=>{"EnrollmentCount"=>"158"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"October 2021", "CompletionDateStruct"=>{"CompletionDate"=>"April 1998", "CompletionDateType"=>"Actual"}, "LastUpdateSubmitDate"=>"October 27, 2021", "StudyFirstSubmitDate"=>"November 2, 1999", "StudyFirstSubmitQCDate"=>"August 30, 2001", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"November 4, 2021", "LastUpdatePostDateType"=>"Actual"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"August 31, 2001", "StudyFirstPostDateType"=>"Estimate"}}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Acquired Immunodeficiency Syndrome", "AIDS-Related Complex", "Fluorouracil", "Cervix Dysplasia", "Cervix Diseases"]}, "ConditionList"=>{"Condition"=>["HIV Infections", "Cervix, Dysplasia"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"8880203", "ReferenceType"=>"background", "ReferenceCitation"=>"Robinson WR, Morris CB. Cervical neoplasia. Pathogenesis, diagnosis, and management. Hematol Oncol Clin North Am. 1996 Oct;10(5):1163-76. doi: 10.1016/s0889-8588(05)70391-9."}, {"ReferenceType"=>"background", "ReferenceCitation"=>"Maiman M, Watts DH, Andersen J. A phase three randomized trial of topical vaginal 5-fluorouracil maintenance therapy versus observation after standard treatment for high grade cervical dysplasia in HIV-infected women: ACTG 200. Conf Retroviruses Opportunistic Infect. 1999 Jan 31-Feb 4;6th:155 (abstract no 466)"}]}}, "DescriptionModule"=>{"BriefSummary"=>"To determine the efficacy and safety of intravaginal fluorouracil administered as prophylaxis in HIV-infected women who have received standard ablative therapy (surgery) for high-grade cervical dysplasia (pre-cancer of the cervix; cervical intraepithelial neoplasia). To correlate time to recurrence of cervical dysplasia with T-cell function.\n\nWomen with HIV infection are at greater risk for cervical dysplasia. Because of the likelihood that untreated or recurrent cervical dysplasia may progress to invasive cancer, there is an urgent need to develop appropriate therapies.", "DetailedDescription"=>"Women with HIV infection are at greater risk for cervical dysplasia. Because of the likelihood that untreated or recurrent cervical dysplasia may progress to invasive cancer, there is an urgent need to develop appropriate therapies.\n\nPatients are randomized to receive either intravaginal fluorouracil or no treatment (observation only). Fluorouracil cream is self-administered via applicator at biweekly intervals for 6 months. Patients are evaluated for recurrent cervical dysplasia by cytology and colposcopy with or without biopsy."}, "EligibilityModule"=>{"Gender"=>"Female", "MinimumAge"=>"13 years", "StdAgeList"=>{"StdAge"=>["Child", "Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\nAntiretrovirals (AZT, ddI, ddC) and immunomodulators (interferon and interleukin).\nProphylaxis or treatment for opportunistic infections.\nVaginal antifungal agents or other indicated vaginal medications (although not permitted on day of fluorouracil application).\nContraceptives.\nAcyclovir (prophylaxis or treatment) in patients with a history of primary or recurrent genital herpes.\n\nPatients must have:\n\nHIV infection.\nPrior cervical dysplasia (grade II or III cervical intraepithelial neoplasia) successfully treated with an ablative procedure within the past 12 weeks.\nPatients less than 18 years of age must have consent of parent or guardian.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms and conditions are excluded:\n\nUntreated or persistent vaginal or vulvar dysplasia.\nColposcopy or biopsy inconclusive or positive for dysplasia.\nActive genital ulcerative disease such as syphilitic chancre or herpes ulcer.\nAdenocarcinoma in situ.\n\nConcurrent Medication:\n\nExcluded:\n\nCytotoxic chemotherapy for malignancy.\nHigh-dose steroids (> 10 mg/day prednisone or its steroid equivalent).\n\nPatients with the following prior conditions are excluded:\n\nMalignancy requiring cytotoxic chemotherapy within the 3 months prior to study entry.\nPrior hysterectomy.\nHistory of allergic reaction or severe hypersensitivity to fluorouracil.\n\nPrior Medication:\n\nExcluded:\n\nFluorouracil (systemic or topical) within 3 months prior to study entry."}, "IdentificationModule"=>{"NCTId"=>"NCT00000758", "BriefTitle"=>"A Phase III Randomized Trial of Topical Vaginal Fluorouracil (5-Fluorouracil, 5-FU) Maintenance Therapy Versus Observation After Standard Treatment for High-Grade Cervical Dysplasia in HIV-Infected Women", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "OfficialTitle"=>"A Phase III Randomized Trial of Topical Vaginal Fluorouracil (5-Fluorouracil, 5-FU) Maintenance Therapy Versus Observation After Standard Treatment for High-Grade Cervical Dysplasia in HIV-Infected Women", "OrgStudyIdInfo"=>{"OrgStudyId"=>"ACTG 200"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"11176", "SecondaryIdType"=>"Registry Identifier", "SecondaryIdDomain"=>"DAIDS ES Registry Number"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Fluorouracil", "InterventionType"=>"Drug"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"90033", "LocationCity"=>"Los Angeles", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"Usc La Nichd Crs"}, {"LocationZip"=>"33136", "LocationCity"=>"Miami", "LocationState"=>"Florida", "LocationCountry"=>"United States", "LocationFacility"=>"Univ. of Miami AIDS CRS"}, {"LocationZip"=>"60611", "LocationCity"=>"Chicago", "LocationState"=>"Illinois", "LocationCountry"=>"United States", "LocationFacility"=>"Northwestern University CRS"}, {"LocationZip"=>"60612", "LocationCity"=>"Chicago", "LocationState"=>"Illinois", "LocationCountry"=>"United States", "LocationFacility"=>"Cook County Hosp. CORE Ctr."}, {"LocationZip"=>"60637", "LocationCity"=>"Chicago", "LocationState"=>"Illinois", "LocationCountry"=>"United States", "LocationFacility"=>"Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease"}, {"LocationZip"=>"70112", "LocationCity"=>"New Orleans", "LocationState"=>"Louisiana", "LocationCountry"=>"United States", "LocationFacility"=>"Tulane/LSU Maternal/Child CRS"}, {"LocationZip"=>"21287", "LocationCity"=>"Baltimore", "LocationState"=>"Maryland", "LocationCountry"=>"United States", "LocationFacility"=>"Johns Hopkins Adult AIDS CRS"}, {"LocationZip"=>"02118", "LocationCity"=>"Boston", "LocationState"=>"Massachusetts", "LocationCountry"=>"United States", "LocationFacility"=>"Bmc Actg Crs"}, {"LocationZip"=>"02215", "LocationCity"=>"Boston", "LocationState"=>"Massachusetts", "LocationCountry"=>"United States", "LocationFacility"=>"Beth Israel Deaconess Med. Ctr., ACTG CRS"}, {"LocationZip"=>"48201", "LocationCity"=>"Detroit", "LocationState"=>"Michigan", "LocationCountry"=>"United States", "LocationFacility"=>"Children's Hospital of Michigan NICHD CRS"}, {"LocationZip"=>"07103", "LocationCity"=>"Newark", "LocationState"=>"New Jersey", "LocationCountry"=>"United States", "LocationFacility"=>"NJ Med. School CRS"}, {"LocationZip"=>"10457", "LocationCity"=>"Bronx", "LocationState"=>"New York", "LocationCountry"=>"United States", "LocationFacility"=>"Bronx-Lebanon Hosp. IMPAACT CRS"}, {"LocationZip"=>"14215", "LocationCity"=>"Buffalo", "LocationState"=>"New York", "LocationCountry"=>"United States", "LocationFacility"=>"SUNY - Buffalo, Erie County Medical Ctr."}, {"LocationZip"=>"10021", "LocationCity"=>"New York", "LocationState"=>"New York", "LocationCountry"=>"United States", "LocationFacility"=>"Memorial Sloan-Kettering Cancer Ctr."}, {"LocationZip"=>"14642", "LocationCity"=>"Rochester", "LocationState"=>"New York", "LocationCountry"=>"United States", "LocationFacility"=>"Univ. of Rochester ACTG CRS"}, {"LocationZip"=>"13210", "LocationCity"=>"Syracuse", "LocationState"=>"New York", "LocationCountry"=>"United States", "LocationFacility"=>"SUNY Upstate Med. Univ., Dept. of Peds."}, {"LocationZip"=>"27599", "LocationCity"=>"Chapel Hill", "LocationState"=>"North Carolina", "LocationCountry"=>"United States", "LocationFacility"=>"Unc Aids Crs"}, {"LocationZip"=>"45267", "LocationCity"=>"Cincinnati", "LocationState"=>"Ohio", "LocationCountry"=>"United States", "LocationFacility"=>"Univ. of Cincinnati CRS"}, {"LocationZip"=>"98122", "LocationCity"=>"Seattle", "LocationState"=>"Washington", "LocationCountry"=>"United States", "LocationFacility"=>"UW School of Medicine - CHRMC"}, {"LocationZip"=>"00936", "LocationCity"=>"San Juan", "LocationCountry"=>"Puerto Rico", "LocationFacility"=>"Puerto Rico-AIDS CRS"}, {"LocationZip"=>"00936", "LocationCity"=>"San Juan", "LocationCountry"=>"Puerto Rico", "LocationFacility"=>"San Juan City Hosp. PR NICHD CRS"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Maiman M", "OverallOfficialRole"=>"Study Chair"}, {"OverallOfficialName"=>"Watts DH", "OverallOfficialRole"=>"Study Chair"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "LeadSponsorClass"=>"NIH"}, "CollaboratorList"=>{"Collaborator"=>[{"CollaboratorName"=>"Hoffmann-La Roche", "CollaboratorClass"=>"INDUSTRY"}]}, "ResponsibleParty"=>{"ResponsiblePartyType"=>"Sponsor"}}}}}}
