Nctid:
NCT00002144
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D007239", "term"=>"Infections"}, {"id"=>"D003141", "term"=>"Communicable Diseases"}, {"id"=>"D014777", "term"=>"Virus Diseases"}, {"id"=>"D006561", "term"=>"Herpes Simplex"}], "ancestors"=>[{"id"=>"D020969", "term"=>"Disease Attributes"}, {"id"=>"D010335", "term"=>"Pathologic Processes"}, {"id"=>"D006566", "term"=>"Herpesviridae Infections"}, {"id"=>"D004266", "term"=>"DNA Virus Infections"}, {"id"=>"D017193", "term"=>"Skin Diseases, Viral"}, {"id"=>"D012874", "term"=>"Skin Diseases, Infectious"}, {"id"=>"D012871", "term"=>"Skin Diseases"}], "browseLeaves"=>[{"id"=>"M17522", "name"=>"Virus Diseases", "asFound"=>"Virus Infection", "relevance"=>"HIGH"}, {"id"=>"M10283", "name"=>"Infections", "asFound"=>"Infection", "relevance"=>"HIGH"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "asFound"=>"Infection", "relevance"=>"HIGH"}, {"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "relevance"=>"LOW"}, {"id"=>"M9639", "name"=>"Herpes Simplex", "asFound"=>"Herpes Simplex", "relevance"=>"HIGH"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M22700", "name"=>"Disease Attributes", "relevance"=>"LOW"}, {"id"=>"M9643", "name"=>"Herpesviridae Infections", "relevance"=>"LOW"}, {"id"=>"M7442", "name"=>"DNA Virus Infections", "relevance"=>"LOW"}, {"id"=>"M15674", "name"=>"Skin Diseases", "relevance"=>"LOW"}, {"id"=>"M19501", "name"=>"Skin Diseases, Viral", "relevance"=>"LOW"}, {"id"=>"M15677", "name"=>"Skin Diseases, Infectious", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D017245", "term"=>"Foscarnet"}, {"id"=>"D010746", "term"=>"Phosphonoacetic Acid"}], "ancestors"=>[{"id"=>"D000998", "term"=>"Antiviral Agents"}, {"id"=>"D000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D018894", "term"=>"Reverse Transcriptase Inhibitors"}, {"id"=>"D019384", "term"=>"Nucleic Acid Synthesis Inhibitors"}, {"id"=>"D004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}], "browseLeaves"=>[{"id"=>"M3567", "name"=>"Acyclovir", "relevance"=>"LOW"}, {"id"=>"M19543", "name"=>"Foscarnet", "asFound"=>"Orlistat", "relevance"=>"HIGH"}, {"id"=>"M13647", "name"=>"Phosphonoacetic Acid", "asFound"=>"Lithotomy position", "relevance"=>"HIGH"}, {"id"=>"M4314", "name"=>"Antiviral Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M20935", "name"=>"Reverse Transcriptase Inhibitors", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>12}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1996-03", "lastUpdateSubmitDate"=>"2005-06-23", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2005-06-24", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Herpes Simplex", "Foscarnet", "Acquired Immunodeficiency Syndrome"], "conditions"=>["Herpes Simplex", "HIV Infections"]}, "referencesModule"=>{"references"=>[{"type"=>"BACKGROUND", "citation"=>"Hardy D, Javaly K, Wohlfeiler M, Kalayjian R, Klein T, Bryson Y, Graford K, Martin-Munley S. Phase I, pilot study of the safety and efficacy of foscarnet (PFA) cream for treatment (Rx) of acyclovir-unresponsive (ACV-R) herpes simplex (HSV). Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:83"}]}, "descriptionModule"=>{"briefSummary"=>"PRIMARY: To evaluate the clinical activity of foscarnet cream on the index lesion of mucocutaneous herpes simplex virus (HSV) infections in immunocompromised patients previously unresponsive to acyclovir treatment.\n\nSECONDARY: To evaluate the clinical activity and virologic activity of foscarnet cream on all treated lesions in this patient population. To evaluate the local tolerance and side effects of treatment with foscarnet cream in this patient population.", "detailedDescription"=>"Patients receive topical applications of one percent foscarnet cream five times daily for up to 6 weeks; those who show no evidence of epithelialization of the index lesion after 3 or more weeks are removed from study and offered intravenous foscarnet. Patients who show a good response to topical foscarnet cream at the end of 6 weeks may continue receiving treatment at the discretion of the investigator."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "minimumAge"=>"13 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Ganciclovir (provided drug was administered for at least 14 days prior to study entry, and the HSV isolate exhibits resistance against acyclovir).\n* Other medication considered necessary for patient's welfare, at the discretion of the investigator.\n\nPatients must have:\n\n* HIV infection or AIDS.\n* Mucocutaneous HSV infection with at least one clinically evaluable lesion.\n* Prior acyclovir without clinical benefit.\n* Life expectancy of at least 3 months.\n* Consent of parent or guardian if less than 18 years of age.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\n* Known hypersensitivity to the study drug.\n* Any medical, psychiatric, or other condition that would preclude study compliance.\n* Incapable of self administration of medication or presence of a care provider administering medication.\n\nConcurrent Medication:\n\nExcluded:\n\n* Intravenous foscarnet for current episode of HSV.\n* Acyclovir, interferon, or any investigational drug that might have anti-HSV activity (e.g., 256U87, HPMPC, BVDaraU, trifluridine).\n\nPatients with the following prior condition are excluded:\n\nPrevious participation in the study.\n\nPrior Medication:\n\nExcluded:\n\n* Intravenous foscarnet within 2 months prior to study entry."}, "identificationModule"=>{"nctId"=>"NCT00002144", "briefTitle"=>"The Pilot Study of Foscarnet Cream in the Treatment of Mucocutaneous Herpes Simplex Virus Infections in Immunocompromised Patients Unresponsive to Acyclovir Treatment", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"NIH AIDS Clinical Trials Information Service"}, "officialTitle"=>"The Pilot Study of Foscarnet Cream in the Treatment of Mucocutaneous Herpes Simplex Virus Infections in Immunocompromised Patients Unresponsive to Acyclovir Treatment", "orgStudyIdInfo"=>{"id"=>"240A"}, "secondaryIdInfos"=>[{"id"=>"92-FT-57"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Foscarnet sodium", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"90095", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"CARE Ctr / UCLA Med Ctr", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"20037", "city"=>"Washington", "state"=>"District of Columbia", "country"=>"United States", "facility"=>"George Washington Univ Med Ctr", "geoPoint"=>{"lat"=>38.89511, "lon"=>-77.03637}}, {"zip"=>"33143", "city"=>"Miami", "state"=>"Florida", "country"=>"United States", "facility"=>"South Miami Hosp", "geoPoint"=>{"lat"=>25.77427, "lon"=>-80.19366}}, {"zip"=>"60610", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Dr Thomas Klein", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"10016", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Bellevue Hosp Ctr", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"44106", "city"=>"Cleveland", "state"=>"Ohio", "country"=>"United States", "facility"=>"Univ Hosps of Cleveland", "geoPoint"=>{"lat"=>41.4995, "lon"=>-81.69541}}, {"zip"=>"02908", "city"=>"Providence", "state"=>"Rhode Island", "country"=>"United States", "facility"=>"Roger Williams Med Ctr", "geoPoint"=>{"lat"=>41.82399, "lon"=>-71.41283}}, {"zip"=>"53226", "city"=>"Milwaukee", "state"=>"Wisconsin", "country"=>"United States", "facility"=>"Milwaukee County Med Complex", "geoPoint"=>{"lat"=>43.0389, "lon"=>-87.90647}}], "overallOfficials"=>[{"name"=>"Hardy WD", "role"=>"STUDY_CHAIR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Astra USA", "class"=>"INDUSTRY"}}}}
