Nctid:
NCT00002251
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-06"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D007239", "term"=>"Infections"}, {"id"=>"D003141", "term"=>"Communicable Diseases"}, {"id"=>"D003586", "term"=>"Cytomegalovirus Infections"}], "ancestors"=>[{"id"=>"D020969", "term"=>"Disease Attributes"}, {"id"=>"D010335", "term"=>"Pathologic Processes"}, {"id"=>"D014777", "term"=>"Virus Diseases"}, {"id"=>"D006566", "term"=>"Herpesviridae Infections"}, {"id"=>"D004266", "term"=>"DNA Virus Infections"}], "browseLeaves"=>[{"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M10283", "name"=>"Infections", "asFound"=>"Infection", "relevance"=>"HIGH"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "asFound"=>"Infection", "relevance"=>"HIGH"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "relevance"=>"LOW"}, {"id"=>"M6791", "name"=>"Cytomegalovirus Infections", "asFound"=>"Cytomegalovirus Infections", "relevance"=>"HIGH"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M12825", "name"=>"Opportunistic Infections", "relevance"=>"LOW"}, {"id"=>"M19410", "name"=>"AIDS-Related Opportunistic Infections", "relevance"=>"LOW"}, {"id"=>"M22700", "name"=>"Disease Attributes", "relevance"=>"LOW"}, {"id"=>"M17522", "name"=>"Virus Diseases", "relevance"=>"LOW"}, {"id"=>"M9643", "name"=>"Herpesviridae Infections", "relevance"=>"LOW"}, {"id"=>"M7442", "name"=>"DNA Virus Infections", "relevance"=>"LOW"}, {"id"=>"T1720", "name"=>"Cytomegalic Inclusion Disease", "asFound"=>"Cytomegalovirus Infections", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D015774", "term"=>"Ganciclovir"}, {"id"=>"C092309", "term"=>"Ganciclovir triphosphate"}], "ancestors"=>[{"id"=>"D000998", "term"=>"Antiviral Agents"}, {"id"=>"D000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D019384", "term"=>"Nucleic Acid Synthesis Inhibitors"}, {"id"=>"D004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}], "browseLeaves"=>[{"id"=>"M18331", "name"=>"Ganciclovir", "asFound"=>"Cortisol", "relevance"=>"HIGH"}, {"id"=>"M340476", "name"=>"Ganciclovir triphosphate", "asFound"=>"Cortisol", "relevance"=>"HIGH"}, {"id"=>"M4314", "name"=>"Antiviral Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "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"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>20}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1991-05", "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"=>["AIDS-Related Opportunistic Infections", "Ganciclovir", "Cytomegalovirus Infections", "Acquired Immunodeficiency Syndrome", "Biological Availability"], "conditions"=>["Cytomegalovirus Infections", "HIV Infections"]}, "referencesModule"=>{"references"=>[{"pmid"=>"8690817", "type"=>"BACKGROUND", "citation"=>"Lavelle J, Follansbee S, Trapnell CB, Buhles WC, Griffy KG, Jung D, Dorr A, Connor J. Effect of food on the relative bioavailability of oral ganciclovir. J Clin Pharmacol. 1996 Mar;36(3):238-41. doi: 10.1002/j.1552-4604.1996.tb04193.x."}]}, "descriptionModule"=>{"briefSummary"=>"This study is designed to determine the influence of food on the absorption and relative bioavailability of oral ganciclovir by comparing the absorption of oral ganciclovir in a fed and fasting state at steady state plasma levels."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT"], "maximumAge"=>"60 years", "minimumAge"=>"13 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nPatients must have the following:\n\n* Confirmation of HIV infection by HIV antibody testing, p24 antigen, or culture of HIV.\n* Documented confirmation of present or past CMV infection.\n* Must understand the nature of the study, agree to tests required in the protocol, and must understand and sign an informed Consent form approved by the appropriate Institutional Review Board and by Syntex.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following conditions or symptoms are excluded:\n\n* Uncontrolled diarrhea or clinically significant gastrointestinal symptoms including persistent nausea or abdominal pain.\n\nConcurrent Medication:\n\nExcluded:\n\n* Antimetabolites. Interferons. Other nucleoside analogs. Zidovudine (AZT). Any investigational drug.\n\nPatients with the following are excluded:\n\n* Any concomitant conditions listed in Exclusion Co-Existing Conditions.\n* Karnofsky score \\< 70.\n* Hypersensitivity to acyclovir.\n* Displaying signs of dementia or decreased mentation which would interfere with the ability of the subject to follow protocol schedule.\n\nPrior Medication:\n\nExcluded:\n\n* Anti-cytomegalovirus therapy including ganciclovir therapy for treatment of CMV disease.\n* Excluded within 4 days of study entry:\n* Antimetabolites.\n* Interferons.\n* Other nucleoside analogs.\n* Zidovudine (AZT)."}, "identificationModule"=>{"nctId"=>"NCT00002251", "briefTitle"=>"A Multiple Dose Crossover Pharmacokinetics Study to Evaluate the Effects of Food on the Absorption of Oral Ganciclovir", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"NIH AIDS Clinical Trials Information Service"}, "officialTitle"=>"A Multiple Dose Crossover Pharmacokinetics Study to Evaluate the Effects of Food on the Absorption of Oral Ganciclovir", "orgStudyIdInfo"=>{"id"=>"059A"}, "secondaryIdInfos"=>[{"id"=>"ICM 1775"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Ganciclovir", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"94114", "city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"Davies Med Ctr", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"20007", "city"=>"Washington", "state"=>"District of Columbia", "country"=>"United States", "facility"=>"Georgetown Univ Med Ctr", "geoPoint"=>{"lat"=>38.89511, "lon"=>-77.03637}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Hoffmann-La Roche", "class"=>"INDUSTRY"}}}}
