Nctid:
NCT00001128
Payload:
{"FullStudy"=>{"Rank"=>474490, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"December 08, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000003457", "ConditionMeshTerm"=>"Cryptosporidiosis"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000007239", "ConditionAncestorTerm"=>"Infections"}, {"ConditionAncestorId"=>"D000007411", "ConditionAncestorTerm"=>"Intestinal Diseases, Parasitic"}, {"ConditionAncestorId"=>"D000010272", "ConditionAncestorTerm"=>"Parasitic Diseases"}, {"ConditionAncestorId"=>"D000011529", "ConditionAncestorTerm"=>"Protozoan Infections, Animal"}, {"ConditionAncestorId"=>"D000010273", "ConditionAncestorTerm"=>"Parasitic Diseases, Animal"}, {"ConditionAncestorId"=>"D000003048", "ConditionAncestorTerm"=>"Coccidiosis"}, {"ConditionAncestorId"=>"D000011528", "ConditionAncestorTerm"=>"Protozoan Infections"}, {"ConditionAncestorId"=>"D000007410", "ConditionAncestorTerm"=>"Intestinal Diseases"}, {"ConditionAncestorId"=>"D000005767", "ConditionAncestorTerm"=>"Gastrointestinal Diseases"}, {"ConditionAncestorId"=>"D000004066", "ConditionAncestorTerm"=>"Digestive System 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"=>"M9889", "ConditionBrowseLeafName"=>"Immunologic Deficiency Syndromes", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M3212", "ConditionBrowseLeafName"=>"Acquired Immunodeficiency Syndrome", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M12515", "ConditionBrowseLeafName"=>"Opportunistic Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M19100", "ConditionBrowseLeafName"=>"AIDS-Related Opportunistic Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M6358", "ConditionBrowseLeafName"=>"Cryptosporidiosis", "ConditionBrowseLeafAsFound"=>"Cryptosporidiosis", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M10134", "ConditionBrowseLeafName"=>"Intestinal Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M10135", "ConditionBrowseLeafName"=>"Intestinal Diseases, Parasitic", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M12875", "ConditionBrowseLeafName"=>"Parasitic Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M14078", "ConditionBrowseLeafName"=>"Protozoan Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M5966", "ConditionBrowseLeafName"=>"Coccidioidomycosis", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M5967", "ConditionBrowseLeafName"=>"Coccidiosis", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M8573", "ConditionBrowseLeafName"=>"Gastrointestinal Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M6945", "ConditionBrowseLeafName"=>"Digestive System Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"T1303", "ConditionBrowseLeafName"=>"Chronic Graft Versus Host Disease", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"T1672", "ConditionBrowseLeafName"=>"Cryptosporidiosis", "ConditionBrowseLeafAsFound"=>"Cryptosporidiosis", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"T1374", "ConditionBrowseLeafName"=>"Coccidioidomycosis", "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"=>"D000017963", "InterventionMeshTerm"=>"Azithromycin"}, {"InterventionMeshId"=>"D000010303", "InterventionMeshTerm"=>"Paromomycin"}, {"InterventionMeshId"=>"D000018664", "InterventionMeshTerm"=>"Interleukin-12"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000000900", "InterventionAncestorTerm"=>"Anti-Bacterial Agents"}, {"InterventionAncestorId"=>"D000000890", "InterventionAncestorTerm"=>"Anti-Infective Agents"}, {"InterventionAncestorId"=>"D000000276", "InterventionAncestorTerm"=>"Adjuvants, Immunologic"}, {"InterventionAncestorId"=>"D000007155", "InterventionAncestorTerm"=>"Immunologic Factors"}, {"InterventionAncestorId"=>"D000045505", "InterventionAncestorTerm"=>"Physiological Effects of Drugs"}, {"InterventionAncestorId"=>"D000020533", "InterventionAncestorTerm"=>"Angiogenesis Inhibitors"}, {"InterventionAncestorId"=>"D000043924", "InterventionAncestorTerm"=>"Angiogenesis Modulating Agents"}, {"InterventionAncestorId"=>"D000006133", "InterventionAncestorTerm"=>"Growth Substances"}, {"InterventionAncestorId"=>"D000006131", "InterventionAncestorTerm"=>"Growth Inhibitors"}, {"InterventionAncestorId"=>"D000000970", "InterventionAncestorTerm"=>"Antineoplastic Agents"}, {"InterventionAncestorId"=>"D000000981", "InterventionAncestorTerm"=>"Antiprotozoal Agents"}, {"InterventionAncestorId"=>"D000000977", "InterventionAncestorTerm"=>"Antiparasitic Agents"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M19822", "InterventionBrowseLeafName"=>"Azithromycin", "InterventionBrowseLeafAsFound"=>"Neoadjuvant", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M12906", "InterventionBrowseLeafName"=>"Paromomycin", "InterventionBrowseLeafAsFound"=>"Blood glucose levels", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M20437", "InterventionBrowseLeafName"=>"Interleukin-12", "InterventionBrowseLeafAsFound"=>"g/dL", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M3912", "InterventionBrowseLeafName"=>"Anti-Bacterial Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3904", "InterventionBrowseLeafName"=>"Anti-Infective Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3318", "InterventionBrowseLeafName"=>"Adjuvants, Immunologic", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M9891", "InterventionBrowseLeafName"=>"Immunologic Factors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M22008", "InterventionBrowseLeafName"=>"Angiogenesis Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M8921", "InterventionBrowseLeafName"=>"Growth Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3988", "InterventionBrowseLeafName"=>"Antiprotozoal Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3984", "InterventionBrowseLeafName"=>"Antiparasitic Agents", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Anti-Infective Agents", "InterventionBrowseBranchAbbrev"=>"Infe"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}, {"InterventionBrowseBranchName"=>"Antineoplastic Agents", "InterventionBrowseBranchAbbrev"=>"ANeo"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Not Applicable"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignMaskingInfo"=>{"DesignMasking"=>"Double"}, "DesignPrimaryPurpose"=>"Treatment"}, "EnrollmentInfo"=>{"EnrollmentCount"=>"16"}}, "StatusModule"=>{"OverallStatus"=>"Terminated", "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"June 2003", "CompletionDateStruct"=>{"CompletionDate"=>"June 2005", "CompletionDateType"=>"Actual"}, "LastUpdateSubmitDate"=>"December 13, 2016", "StudyFirstSubmitDate"=>"January 17, 2000", "StudyFirstSubmitQCDate"=>"August 30, 2001", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"December 14, 2016", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"August 31, 2001", "StudyFirstPostDateType"=>"Estimate"}, "PrimaryCompletionDateStruct"=>{"PrimaryCompletionDate"=>"June 2005", "PrimaryCompletionDateType"=>"Actual"}}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["AIDS-Related Opportunistic Infections", "Cryptosporidiosis", "Acquired Immunodeficiency Syndrome", "Azithromycin", "Paromomycin", "Interleukin-12"]}, "ConditionList"=>{"Condition"=>["Cryptosporidiosis", "HIV Infections"]}}, "DescriptionModule"=>{"BriefSummary"=>"The purpose of this study is to see if it is safe and effective to add interleukin-12 (IL-12) to the standard drug combination (paromomycin plus azithromycin) used to treat cryptosporidiosis in AIDS patients. Doctors would like to find out if the combination of IL-12, paromomycin, and azithromycin is more effective than paromomycin and azithromycin alone.\n\nCryptosporidiosis is a type of opportunistic (AIDS-related) infection seen in HIV-positive patients as their immune systems weaken. It is caused by a parasite that invades the intestinal tract, and it can cause watery diarrhea, stomach cramps, an upset stomach, or a fever. Antibiotics (paromomycin and azithromycin) are usually used to treat cryptosporidiosis. In this study, doctors will look at the effectiveness of using IL-12. IL-12 is a type of protein naturally produced by certain types of cells of the immune system and is believed to be important for immune function. Doctors hope that IL-12 can help boost the immune system in fighting cryptosporidiosis.", "DetailedDescription"=>"Cryptosporidium parvum, an intracellular protozoan parasite, is a frequent cause of chronic diarrhea in HIV-infected patients, causing significant morbidity and mortality. Highly effective antiparasitic treatment for this infection is not currently available. Paromomycin and azithromycin have some efficacy and have been used in combination in a small number of patients. Immune reconstitution with highly active antiretroviral therapy appears to be the most effective therapy, but this is not possible for all patients. Interferon gamma expression is strongly associated with control of cryptosporidiosis, and IL-12 is the cytokine primarily responsible for stimulation of interferon gamma expression in vivo. It is hoped that treatment with recombinant human IL-12 can result in stimulation of an intestinal cytokine response in AIDS patients with cryptosporidiosis and that response combined with chemotherapy can lead to the elimination of detectable numbers of Cryptosporidium oocysts from the stools.\n\nAll patients receive azithromycin and paromomycin, and patients are randomized to add either IL-12 or placebo. IL-12 (or placebo) injections are given twice a week. Patients take their study medications for 4 weeks. During this time, they will be asked to record bowel movements and any symptoms they experience. Patients return to the clinic at least twice a week to receive IL-12 (or placebo) injections. At Weeks 2 and 4, patients are seen by one of the principal investigators. Blood samples are obtained for viral load measurements and CD4 count, as well as routine urinalysis. Patients undergo upper endoscopy with jejunal biopsy and colonoscopy with ileal biopsy between Weeks 2 and 4 of therapy for assays of intestinal cytokine expression. A final clinic visit occurs 12 weeks post-therapy for a physical exam and blood tests."}, "EligibilityModule"=>{"Gender"=>"All", "MinimumAge"=>"18 years", "StdAgeList"=>{"StdAge"=>["Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Inclusion Criteria\n\nPatients may be eligible for this study if they:\n\nAre HIV-positive.\nHave a CD4 cell count below 150 cells/mm3.\nHave been on stable anti-HIV therapy that includes at least 2 nucleoside analogues for at least 4 weeks.\nHave chronic diarrhea (3 bowel movements a day that are loose or watery, for 5 days per week over 3 weeks).\nTest positively for Cryptosporidium.\nAre at least 18 years old.\nAgree to use effective methods of birth control.\n\nExclusion Criteria\n\nPatients will not be eligible for this study if they:\n\nHave any other active opportunistic (AIDS-related) infection.\nRequire intravenous (IV) fluids.\nHave a history of an allergy to certain medications, such as colony-stimulating factors (G-CSF or GM-CSF) or a type of antibiotic.\nAre pregnant."}, "IdentificationModule"=>{"NCTId"=>"NCT00001128", "BriefTitle"=>"Treatment of Chronic Cryptosporidiosis in AIDS Patients", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "OfficialTitle"=>"A Pilot, Proof-of-Concept, Dose-Escalating Trial of Recombinant Human Interleukin-12 (rhIL-12) Versus Placebo Along With Paromomycin and Azithromycin for Chronic Cryptosporidiosis in AIDS", "OrgStudyIdInfo"=>{"OrgStudyId"=>"DAIDS R001"}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Interleukin-12", "InterventionType"=>"Drug"}, {"InterventionName"=>"Paromomycin sulfate", "InterventionType"=>"Drug"}, {"InterventionName"=>"Azithromycin", "InterventionType"=>"Drug"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"77030", "LocationCity"=>"Houston", "LocationState"=>"Texas", "LocationCountry"=>"United States", "LocationFacility"=>"Pablo C. Okhuysen"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"A. Clinton White", "OverallOfficialRole"=>"Principal Investigator"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "LeadSponsorClass"=>"NIH"}, "CollaboratorList"=>{"Collaborator"=>[{"CollaboratorName"=>"Genetics Institute", "CollaboratorClass"=>"INDUSTRY"}]}}}}}}
