Nctid:
NCT00000768
Payload:
{"FullStudy"=>{"Rank"=>474844, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"December 08, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000003092", "ConditionMeshTerm"=>"Colitis"}, {"ConditionMeshId"=>"D000005767", "ConditionMeshTerm"=>"Gastrointestinal Diseases"}, {"ConditionMeshId"=>"D000004066", "ConditionMeshTerm"=>"Digestive System Diseases"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000005759", "ConditionAncestorTerm"=>"Gastroenteritis"}, {"ConditionAncestorId"=>"D000003108", "ConditionAncestorTerm"=>"Colonic Diseases"}, {"ConditionAncestorId"=>"D000007410", "ConditionAncestorTerm"=>"Intestinal Diseases"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M16045", "ConditionBrowseLeafName"=>"Syndrome", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M9973", "ConditionBrowseLeafName"=>"Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M6058", "ConditionBrowseLeafName"=>"Communicable Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M17940", "ConditionBrowseLeafName"=>"HIV Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M8573", "ConditionBrowseLeafName"=>"Gastrointestinal Diseases", "ConditionBrowseLeafAsFound"=>"Gastrointestinal Diseases", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M6945", "ConditionBrowseLeafName"=>"Digestive System Diseases", "ConditionBrowseLeafAsFound"=>"Gastrointestinal Diseases", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M9889", "ConditionBrowseLeafName"=>"Immunologic Deficiency Syndromes", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M6481", "ConditionBrowseLeafName"=>"Cytomegalovirus Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M6010", "ConditionBrowseLeafName"=>"Colitis", "ConditionBrowseLeafAsFound"=>"Colitis", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M3212", "ConditionBrowseLeafName"=>"Acquired Immunodeficiency Syndrome", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M8565", "ConditionBrowseLeafName"=>"Gastroenteritis", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M6026", "ConditionBrowseLeafName"=>"Colonic Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M10134", "ConditionBrowseLeafName"=>"Intestinal Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"T1720", "ConditionBrowseLeafName"=>"Cytomegalic Inclusion Disease", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Symptoms and General Pathology", "ConditionBrowseBranchAbbrev"=>"BC23"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Infections", "ConditionBrowseBranchAbbrev"=>"BC01"}, {"ConditionBrowseBranchName"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "ConditionBrowseBranchAbbrev"=>"BXS"}, {"ConditionBrowseBranchName"=>"Immune System Diseases", "ConditionBrowseBranchAbbrev"=>"BC20"}, {"ConditionBrowseBranchName"=>"Digestive System Diseases", "ConditionBrowseBranchAbbrev"=>"BC06"}, {"ConditionBrowseBranchName"=>"Rare Diseases", "ConditionBrowseBranchAbbrev"=>"Rare"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"D000015774", "InterventionMeshTerm"=>"Ganciclovir"}, {"InterventionMeshId"=>"C000092309", "InterventionMeshTerm"=>"Ganciclovir triphosphate"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000000998", "InterventionAncestorTerm"=>"Antiviral Agents"}, {"InterventionAncestorId"=>"D000000890", "InterventionAncestorTerm"=>"Anti-Infective Agents"}, {"InterventionAncestorId"=>"D000019384", "InterventionAncestorTerm"=>"Nucleic Acid Synthesis Inhibitors"}, {"InterventionAncestorId"=>"D000004791", "InterventionAncestorTerm"=>"Enzyme Inhibitors"}, {"InterventionAncestorId"=>"D000045504", "InterventionAncestorTerm"=>"Molecular Mechanisms of Pharmacological Action"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M18021", "InterventionBrowseLeafName"=>"Ganciclovir", "InterventionBrowseLeafAsFound"=>"Roux-en-Y", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M340407", "InterventionBrowseLeafName"=>"Ganciclovir triphosphate", "InterventionBrowseLeafAsFound"=>"Roux-en-Y", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M4004", "InterventionBrowseLeafName"=>"Antiviral Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3904", "InterventionBrowseLeafName"=>"Anti-Infective Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M7641", "InterventionBrowseLeafName"=>"Enzyme Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"T5", "InterventionBrowseLeafName"=>"Glutamic Acid", "InterventionBrowseLeafAsFound"=>"Hepatitis A", "InterventionBrowseLeafRelevance"=>"high"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Anti-Infective Agents", "InterventionBrowseBranchAbbrev"=>"Infe"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}, {"InterventionBrowseBranchName"=>"Amino Acids", "InterventionBrowseBranchAbbrev"=>"AA"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 1"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignAllocation"=>"Randomized", "DesignPrimaryPurpose"=>"Treatment"}, "EnrollmentInfo"=>{"EnrollmentCount"=>"24"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"October 2021", "CompletionDateStruct"=>{"CompletionDate"=>"August 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"=>["Intestinal Absorption", "Ganciclovir", "Drug Therapy, Combination", "Cytomegalovirus Infections", "Colitis", "Administration, Oral", "Acquired Immunodeficiency Syndrome", "Biological Availability", "Glutamic Acid"]}, "ConditionList"=>{"Condition"=>["Colitis", "HIV Infections"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"8380610", "ReferenceType"=>"background", "ReferenceCitation"=>"Dieterich DT, Kotler DP, Busch DF, Crumpacker C, Du Mond C, Dearmand B, Buhles W. Ganciclovir treatment of cytomegalovirus colitis in AIDS: a randomized, double-blind, placebo-controlled multicenter study. J Infect Dis. 1993 Feb;167(2):278-82. doi: 10.1093/infdis/167.2.278."}]}}, "DescriptionModule"=>{"BriefSummary"=>"To determine the oral bioavailability of three dose levels of oral ganciclovir given with and without glutamic acid hydrochloride in patients with cytomegalovirus (CMV) GI disease, and to compare the bioavailability of these regimens to that of standard intravenous (IV) ganciclovir.\n\nLong-term ganciclovir maintenance therapy has been recommended for CMV colitis or esophagitis following induction treatment. Oral ganciclovir is a likely candidate for maintenance because of its possible therapeutic value and ease of administration, but an optimum dose has not been determined. Since oral ganciclovir has a low bioavailability and is more soluble in an acid pH environment, the addition of glutamic acid hydrochloride may enhance gastrointestinal absorption of this drug.", "DetailedDescription"=>"Long-term ganciclovir maintenance therapy has been recommended for CMV colitis or esophagitis following induction treatment. Oral ganciclovir is a likely candidate for maintenance because of its possible therapeutic value and ease of administration, but an optimum dose has not been determined. Since oral ganciclovir has a low bioavailability and is more soluble in an acid pH environment, the addition of glutamic acid hydrochloride may enhance gastrointestinal absorption of this drug.\n\nAll patients receive an induction regimen of IV ganciclovir administered twice daily for 21 to 42 (Per Amendment 3/4/95) days. A permanent venous catheter is implanted for the induction therapy. If clinically improved following induction, patients are then randomized to receive one of three doses of oral ganciclovir, given first without and then with oral glutamic acid hydrochloride, every 8 hours until they reach a steady state. PER AMENDMENT 3/14/95: After subjects have reached steady state with oral ganciclovir and glutamic acid hydrochloride then PK samples will be taken. Subjects will continue the dosing regimen they were assigned to (glutamic acid hydrochloride will be added if it resulted in at least 33% increased bioavailability) for up to 12 months or until relapse of CMV GI disease is documented. Subjects will be followed at monthly intervals for safety evaluation and for evidence of CMV GI relapse. Subjects who have clinical symptoms of relapse will undergo repeat endoscopy or colonoscopy to document the relapse."}, "EligibilityModule"=>{"Gender"=>"All", "MinimumAge"=>"13 years", "StdAgeList"=>{"StdAge"=>["Child", "Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nRecommended:\n\nPCP prophylaxis.\n\nAllowed:\n\nAntiretroviral therapy during induction and pharmacokinetic part of study, provided patient remains on the same antiretroviral therapy for the duration of the study.\nChemotherapy for Kaposi's sarcoma, provided patient is hematologically stable for at least 30 days prior to study entry.\nRecombinant human erythropoietin.\nGM-CSF and G-CSF.\nOther medications necessary for patient's welfare, at the physician's discretion.\n\nPatients must have:\n\nHIV infection.\nBiopsy-proven cytomegalovirus (CMV) colitis.\nLife expectancy of at least 3 months.\nNo active AIDS-defining opportunistic infection requiring therapy that is known to cause nephrotoxicity or myelosuppression.\n\nNOTE:\n\nKaposi's sarcoma is permitted if patients are hematologically stable for at least 30 days prior to study entry.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\nOther etiologies for diarrhea identified at study entry.\n\nPER AMENDMENT 3/14/95:\n\nFor subjects who have diarrhea - no other etiologies for diarrhea identified within 6 weeks of enrollment.\nKnown hypersensitivity to study drugs.\nCMV retinitis.\n\nConcurrent Medication:\n\nExcluded:\n\nAcyclovir or probenecid (PER AMENDMENT 3/14/95).\nImmunomodulators.\nBiologic response modifiers (other than GM-CSF or G-CSF).\nInvestigational agents, with the exception of treatment IND drugs.\nAntacids.\nH2 blockers.\nProton pump inhibitors.\nFoscarnet during induction and pharmacokinetic part of study.\nIntravenous CMV retinitis maintenance therapy (including ganciclovir) during pharmacokinetic part of study.\nNephrotoxic agents.\n\nPrior Medication:\n\nExcluded within 14 days prior to study entry:\n\nImmunomodulators.\nBiologic response modifiers (other than GM-CSF or G-CSF).\nInvestigational agents, with the exception of treatment IND drugs."}, "IdentificationModule"=>{"NCTId"=>"NCT00000768", "BriefTitle"=>"A Randomized Comparative Pharmacokinetic Study of Oral Ganciclovir After Treatment With Intravenous Ganciclovir for Cytomegalovirus Gastrointestinal Disease in AIDS Patients", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "OfficialTitle"=>"A Randomized Comparative Pharmacokinetic Study of Oral Ganciclovir After Treatment With Intravenous Ganciclovir for Cytomegalovirus Gastrointestinal Disease in AIDS Patients", "OrgStudyIdInfo"=>{"OrgStudyId"=>"ACTG 183"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"11158", "SecondaryIdType"=>"Registry Identifier", "SecondaryIdDomain"=>"DAIDS ES Registry Number"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Glutamic acid hydrochloride", "InterventionType"=>"Drug"}, {"InterventionName"=>"Ganciclovir", "InterventionType"=>"Drug"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"35294", "LocationCity"=>"Birmingham", "LocationState"=>"Alabama", "LocationCountry"=>"United States", "LocationFacility"=>"Alabama Therapeutics CRS"}, {"LocationCity"=>"San Francisco", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"Ucsf Aids Crs"}, {"LocationCity"=>"Saint Louis", "LocationState"=>"Missouri", "LocationCountry"=>"United States", "LocationFacility"=>"Washington U CRS"}, {"LocationZip"=>"10016", "LocationCity"=>"New York", "LocationState"=>"New York", "LocationCountry"=>"United States", "LocationFacility"=>"NY Univ. HIV/AIDS CRS"}, {"LocationZip"=>"45267", "LocationCity"=>"Cincinnati", "LocationState"=>"Ohio", "LocationCountry"=>"United States", "LocationFacility"=>"Univ. of Cincinnati CRS"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Jacobson M", "OverallOfficialRole"=>"Study Chair"}, {"OverallOfficialName"=>"Dieterich D", "OverallOfficialRole"=>"Study Chair"}, {"OverallOfficialName"=>"Kotler D", "OverallOfficialRole"=>"Study Chair"}, {"OverallOfficialName"=>"Laine L", "OverallOfficialRole"=>"Study Chair"}, {"OverallOfficialName"=>"Kumar P", "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"}}}}}}