Nctid:
NCT00000764
Payload:
{"FullStudy"=>{"Rank"=>498566, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"June 24, 2024"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000007239", "ConditionMeshTerm"=>"Infections"}, {"ConditionMeshId"=>"D000003141", "ConditionMeshTerm"=>"Communicable Diseases"}, {"ConditionMeshId"=>"D000015658", "ConditionMeshTerm"=>"HIV Infections"}, {"ConditionMeshId"=>"D000000163", "ConditionMeshTerm"=>"Acquired Immunodeficiency Syndrome"}, {"ConditionMeshId"=>"D000030361", "ConditionMeshTerm"=>"Papillomavirus Infections"}, {"ConditionMeshId"=>"D000001005", "ConditionMeshTerm"=>"Anus Neoplasms"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000020969", "ConditionAncestorTerm"=>"Disease Attributes"}, {"ConditionAncestorId"=>"D000010335", "ConditionAncestorTerm"=>"Pathologic Processes"}, {"ConditionAncestorId"=>"D000009369", "ConditionAncestorTerm"=>"Neoplasms"}, {"ConditionAncestorId"=>"D000086982", "ConditionAncestorTerm"=>"Blood-Borne Infections"}, {"ConditionAncestorId"=>"D000015229", "ConditionAncestorTerm"=>"Sexually Transmitted Diseases, Viral"}, {"ConditionAncestorId"=>"D000012749", "ConditionAncestorTerm"=>"Sexually Transmitted Diseases"}, {"ConditionAncestorId"=>"D000016180", "ConditionAncestorTerm"=>"Lentivirus Infections"}, {"ConditionAncestorId"=>"D000012192", "ConditionAncestorTerm"=>"Retroviridae Infections"}, {"ConditionAncestorId"=>"D000012327", "ConditionAncestorTerm"=>"RNA Virus Infections"}, {"ConditionAncestorId"=>"D000014777", "ConditionAncestorTerm"=>"Virus Diseases"}, {"ConditionAncestorId"=>"D000091662", "ConditionAncestorTerm"=>"Genital Diseases"}, {"ConditionAncestorId"=>"D000091642", "ConditionAncestorTerm"=>"Urogenital Diseases"}, {"ConditionAncestorId"=>"D000007153", "ConditionAncestorTerm"=>"Immunologic Deficiency Syndromes"}, {"ConditionAncestorId"=>"D000007154", "ConditionAncestorTerm"=>"Immune System Diseases"}, {"ConditionAncestorId"=>"D000012897", "ConditionAncestorTerm"=>"Slow Virus Diseases"}, {"ConditionAncestorId"=>"D000004266", "ConditionAncestorTerm"=>"DNA Virus Infections"}, {"ConditionAncestorId"=>"D000014412", "ConditionAncestorTerm"=>"Tumor Virus Infections"}, {"ConditionAncestorId"=>"D000012004", "ConditionAncestorTerm"=>"Rectal Neoplasms"}, {"ConditionAncestorId"=>"D000015179", "ConditionAncestorTerm"=>"Colorectal Neoplasms"}, {"ConditionAncestorId"=>"D000007414", "ConditionAncestorTerm"=>"Intestinal Neoplasms"}, {"ConditionAncestorId"=>"D000005770", "ConditionAncestorTerm"=>"Gastrointestinal Neoplasms"}, {"ConditionAncestorId"=>"D000004067", "ConditionAncestorTerm"=>"Digestive System Neoplasms"}, {"ConditionAncestorId"=>"D000009371", "ConditionAncestorTerm"=>"Neoplasms by Site"}, {"ConditionAncestorId"=>"D000004066", "ConditionAncestorTerm"=>"Digestive System Diseases"}, {"ConditionAncestorId"=>"D000005767", "ConditionAncestorTerm"=>"Gastrointestinal Diseases"}, {"ConditionAncestorId"=>"D000007410", "ConditionAncestorTerm"=>"Intestinal Diseases"}, {"ConditionAncestorId"=>"D000001004", "ConditionAncestorTerm"=>"Anus Diseases"}, {"ConditionAncestorId"=>"D000012002", "ConditionAncestorTerm"=>"Rectal Diseases"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M16355", "ConditionBrowseLeafName"=>"Syndrome", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M12307", "ConditionBrowseLeafName"=>"Neoplasm Metastasis", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M10283", "ConditionBrowseLeafName"=>"Infections", "ConditionBrowseLeafAsFound"=>"Infection", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M6368", "ConditionBrowseLeafName"=>"Communicable Diseases", "ConditionBrowseLeafAsFound"=>"Infection", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M23687", "ConditionBrowseLeafName"=>"Papillomavirus Infections", "ConditionBrowseLeafAsFound"=>"Papillomavirus Infection", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M4321", "ConditionBrowseLeafName"=>"Anus Neoplasms", "ConditionBrowseLeafAsFound"=>"Anus Neoplasms", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M3522", "ConditionBrowseLeafName"=>"Acquired Immunodeficiency Syndrome", "ConditionBrowseLeafAsFound"=>"HIV Infections", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M18250", "ConditionBrowseLeafName"=>"HIV Infections", "ConditionBrowseLeafAsFound"=>"HIV Infections", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M10199", "ConditionBrowseLeafName"=>"Immunologic Deficiency Syndromes", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M17522", "ConditionBrowseLeafName"=>"Virus Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M17162", "ConditionBrowseLeafName"=>"Tumor Virus Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M3735", "ConditionBrowseLeafName"=>"AIDS-Related Complex", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M22700", "ConditionBrowseLeafName"=>"Disease Attributes", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M2593", "ConditionBrowseLeafName"=>"Blood-Borne Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M15558", "ConditionBrowseLeafName"=>"Sexually Transmitted Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M17933", "ConditionBrowseLeafName"=>"Sexually Transmitted Diseases, Viral", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M18640", "ConditionBrowseLeafName"=>"Lentivirus Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M15026", "ConditionBrowseLeafName"=>"Retroviridae Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M15149", "ConditionBrowseLeafName"=>"RNA Virus Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M2876", "ConditionBrowseLeafName"=>"Genital Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M2875", "ConditionBrowseLeafName"=>"Urogenital Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M10200", "ConditionBrowseLeafName"=>"Immune System Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M15700", "ConditionBrowseLeafName"=>"Slow Virus Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M7442", "ConditionBrowseLeafName"=>"DNA Virus Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M14846", "ConditionBrowseLeafName"=>"Rectal Neoplasms", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M17890", "ConditionBrowseLeafName"=>"Colorectal Neoplasms", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M10448", "ConditionBrowseLeafName"=>"Intestinal Neoplasms", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M8886", "ConditionBrowseLeafName"=>"Gastrointestinal Neoplasms", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M7256", "ConditionBrowseLeafName"=>"Digestive System Neoplasms", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M7255", "ConditionBrowseLeafName"=>"Digestive System Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M8883", "ConditionBrowseLeafName"=>"Gastrointestinal Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M10444", "ConditionBrowseLeafName"=>"Intestinal Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4320", "ConditionBrowseLeafName"=>"Anus Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M14844", "ConditionBrowseLeafName"=>"Rectal Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"T362", "ConditionBrowseLeafName"=>"Anal Cancer", "ConditionBrowseLeafAsFound"=>"Anus Neoplasms", "ConditionBrowseLeafRelevance"=>"high"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Symptoms and General Pathology", "ConditionBrowseBranchAbbrev"=>"BC23"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Neoplasms", "ConditionBrowseBranchAbbrev"=>"BC04"}, {"ConditionBrowseBranchName"=>"Infections", "ConditionBrowseBranchAbbrev"=>"BC01"}, {"ConditionBrowseBranchName"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "ConditionBrowseBranchAbbrev"=>"BXS"}, {"ConditionBrowseBranchName"=>"Digestive System Diseases", "ConditionBrowseBranchAbbrev"=>"BC06"}, {"ConditionBrowseBranchName"=>"Immune System Diseases", "ConditionBrowseBranchAbbrev"=>"BC20"}, {"ConditionBrowseBranchName"=>"Rare Diseases", "ConditionBrowseBranchAbbrev"=>"Rare"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"D000007372", "InterventionMeshTerm"=>"Interferons"}, {"InterventionMeshId"=>"D000016898", "InterventionMeshTerm"=>"Interferon-alpha"}, {"InterventionMeshId"=>"D000077190", "InterventionMeshTerm"=>"Interferon alpha-2"}, {"InterventionMeshId"=>"D000015474", "InterventionMeshTerm"=>"Isotretinoin"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000000970", "InterventionAncestorTerm"=>"Antineoplastic Agents"}, {"InterventionAncestorId"=>"D000000998", "InterventionAncestorTerm"=>"Antiviral Agents"}, {"InterventionAncestorId"=>"D000000890", "InterventionAncestorTerm"=>"Anti-Infective Agents"}, {"InterventionAncestorId"=>"D000007155", "InterventionAncestorTerm"=>"Immunologic Factors"}, {"InterventionAncestorId"=>"D000045505", "InterventionAncestorTerm"=>"Physiological Effects of Drugs"}, {"InterventionAncestorId"=>"D000003879", "InterventionAncestorTerm"=>"Dermatologic Agents"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M18131", "InterventionBrowseLeafName"=>"Isotretinoin", "InterventionBrowseLeafAsFound"=>"Brace", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M10407", "InterventionBrowseLeafName"=>"Interferons", "InterventionBrowseLeafAsFound"=>"Cardiac", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M19243", "InterventionBrowseLeafName"=>"Interferon-alpha", "InterventionBrowseLeafAsFound"=>"Breathing", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M1685", "InterventionBrowseLeafName"=>"Interferon alpha-2", "InterventionBrowseLeafAsFound"=>"Primary care", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M4314", "InterventionBrowseLeafName"=>"Antiviral Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M4214", "InterventionBrowseLeafName"=>"Anti-Infective Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M10201", "InterventionBrowseLeafName"=>"Immunologic Factors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M7074", "InterventionBrowseLeafName"=>"Dermatologic Agents", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Dermatologic Agents", "InterventionBrowseBranchAbbrev"=>"Derm"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}, {"InterventionBrowseBranchName"=>"Anti-Infective Agents", "InterventionBrowseBranchAbbrev"=>"Infe"}, {"InterventionBrowseBranchName"=>"Antineoplastic Agents", "InterventionBrowseBranchAbbrev"=>"ANeo"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 1"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignAllocation"=>"Randomized", "DesignPrimaryPurpose"=>"Treatment"}, "EnrollmentInfo"=>{"EnrollmentCount"=>"98"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"October 2021", "CompletionDateStruct"=>{"CompletionDate"=>"July 1996", "CompletionDateType"=>"Actual"}, "LastUpdateSubmitDate"=>"October 27, 2021", "StudyFirstSubmitDate"=>"November 2, 1999", "StudyFirstSubmitQCDate"=>"August 30, 2001", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"October 28, 2021", "LastUpdatePostDateType"=>"Actual"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"August 31, 2001", "StudyFirstPostDateType"=>"Estimate"}}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Interferon Alfa-2a", "Acquired Immunodeficiency Syndrome", "AIDS-Related Complex", "Anus Neoplasms", "Papillomavirus, Human", "Papovaviridae Infections", "Tumor Virus Infections", "Isotretinoin"]}, "ConditionList"=>{"Condition"=>["HIV Infections", "Anus Neoplasms"]}}, "DescriptionModule"=>{"BriefSummary"=>"PRIMARY: In Phase I, to define a broadly tolerable dose of isotretinoin that can be used in combination with interferon alfa-2a (IFN alfa-2a). In Phase II, to determine trends in efficacy of isotretinoin alone or in combination with IFN alfa-2a as chemoprevention (preventing progression or recurrence) of anal intraepithelial neoplasia ( AIN ) / squamous intraepithelial lesions ( SIL ) in patients with HIV infection.\n\nSECONDARY: To evaluate the effects of isotretinoin alone or in combination with IFN alfa-2a on immune function markers, human papillomavirus (HPV) type, and HPV DNA levels.\n\nPatients with HIV infection have a significant risk of recurrence following local ablation of intraepithelial neoplasia; thus, anogenital epithelial may become an increasingly important cause of morbidity, and possibly mortality, as the HIV epidemic matures. Clinical studies of non-HIV-infected subjects have established that synthetic retinoids inhibit the progression of epithelial preneoplastic conditions and some neoplastic states.", "DetailedDescription"=>"Patients with HIV infection have a significant risk of recurrence following local ablation of intraepithelial neoplasia; thus, anogenital epithelial may become an increasingly important cause of morbidity, and possibly mortality, as the HIV epidemic matures. Clinical studies of non-HIV-infected subjects have established that synthetic retinoids inhibit the progression of epithelial preneoplastic conditions and some neoplastic states.\n\nIn the Phase I portion of the study, 20 patients per site each receive isotretinoin in escalating doses. If a patient experiences grade 2 or worse toxicity (or grade 3 or worse hypertriglyceridemia), dose is reduced to the previously tolerated dose for the remainder of the 6 week period. Patients are then reassessed for anal neoplasia; those with no progression and no grade 2 or worse toxicity receive an additional 6 weeks of isotretinoin in combination with interferon alfa-2a. For Phase II of the study, a separate group of patients who have undergone ablative therapy are randomized to one of three arms (26 patients/arm): isotretinoin alone at the dose tolerated by at least 60 percent of patients in Phase I; isotretinoin plus interferon alfa-2a; or observation only. Treatment continues for 48 weeks."}, "EligibilityModule"=>{"Gender"=>"All", "MinimumAge"=>"18 years", "StdAgeList"=>{"StdAge"=>["Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\nPCP prophylaxis (required for patients with CD4 count < 200 cells/mm3).\nChemoprophylaxis for candidiasis and herpes simplex.\nMetronidazole for up to 14 days.\nErythropoietin.\n\nPatients must have:\n\nHIV seropositivity.\nNO active opportunistic infection requiring treatment with prohibited drugs.\nPhase I - Current grade 1 AIN (i.e., low grade SIL) OR treated or untreated grade 2 or 3 AIN (i.e., high grade SIL).\n\nPhase II - Prior histologically confirmed grade 2 or 3 AIN / high grade SIL, with ablative therapy within the past 30-90 days.\n\nCapability of complying with study protocol.\n\nNOTE:\n\nThe terms condyloma, grade 1 AIN, and low grade SIL are interchangeable. Grade 2 or 3 AIN is interchangeable with high grade SIL.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\nActive medical problems for which the patient is undergoing evaluations or for which prohibited therapy is required.\nOther active malignancies requiring systemic therapy.\nSignificant symptomatic cardiac disease.\n\nNOTE:\n\nPatients with malignancies being managed with local therapy (e.g., Kaposi's sarcoma, basal cell carcinoma) may enroll at the discretion of the site investigator.\n\nConcurrent Medication:\n\nExcluded:\n\nG-CSF (filgrastim).\nMyelosuppressive antibiotics (except co-trimoxazole for PCP prophylaxis).\nCorticosteroids.\nBiologic response modifiers.\nCytotoxic chemotherapy.\n\nConcurrent Treatment:\n\nExcluded:\n\nRadiation therapy.\n\nPatients with the following prior conditions are excluded:\n\nHistory of ventricular arrhythmias or myocardial infarction.\n\nPrior Medication:\n\nExcluded within 20 days prior to study entry:\n\nG-CSF (filgrastim).\nMyelosuppressive antibiotics (except co-trimoxazole for PCP prophylaxis).\nCorticosteroids.\nBiologic response modifiers.\nCytotoxic chemotherapy.\n\nPrior Treatment:\n\nExcluded within 20 days prior to study entry:\n\nRadiation therapy.\n\nExcluded within 14 days prior to study entry:\n\nTransfusion.\n\nActive substance abuse or illegal drug use (alcohol consumption is strongly discouraged)."}, "IdentificationModule"=>{"NCTId"=>"NCT00000764", "BriefTitle"=>"Chemoprevention of Anal Neoplasia Arising Secondary to Anogenital Human Papillomavirus Infection in Persons With HIV Infection.", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "OfficialTitle"=>"Chemoprevention of Anal Neoplasia Arising Secondary to Anogenital Human Papillomavirus Infection in Persons With HIV Infection.", "OrgStudyIdInfo"=>{"OrgStudyId"=>"ACTG 216"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"11193", "SecondaryIdType"=>"Registry Identifier", "SecondaryIdDomain"=>"DAIDS ES Registry Number"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Isotretinoin", "InterventionType"=>"Drug"}, {"InterventionName"=>"Interferon alfa-2a", "InterventionType"=>"Drug"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"98122", "LocationCity"=>"Seattle", "LocationState"=>"Washington", "LocationCountry"=>"United States", "LocationFacility"=>"University of Washington AIDS CRS"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Palefsky JM", "OverallOfficialRole"=>"Study Chair"}, {"OverallOfficialName"=>"Northfelt DW", "OverallOfficialRole"=>"Study Chair"}, {"OverallOfficialName"=>"Kaplan LD", "OverallOfficialRole"=>"Study Chair"}, {"OverallOfficialName"=>"Critchlow C", "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"}}}}}}