Nctid:
NCT00002248
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D003457", "term"=>"Cryptosporidiosis"}, {"id"=>"D004751", "term"=>"Enteritis"}], "ancestors"=>[{"id"=>"D007239", "term"=>"Infections"}, {"id"=>"D005759", "term"=>"Gastroenteritis"}, {"id"=>"D005767", "term"=>"Gastrointestinal Diseases"}, {"id"=>"D004066", "term"=>"Digestive System Diseases"}, {"id"=>"D007410", "term"=>"Intestinal Diseases"}, {"id"=>"D007411", "term"=>"Intestinal Diseases, Parasitic"}, {"id"=>"D010272", "term"=>"Parasitic Diseases"}, {"id"=>"D011529", "term"=>"Protozoan Infections, Animal"}, {"id"=>"D010273", "term"=>"Parasitic Diseases, Animal"}, {"id"=>"D003048", "term"=>"Coccidiosis"}, {"id"=>"D011528", "term"=>"Protozoan Infections"}], "browseLeaves"=>[{"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "relevance"=>"LOW"}, {"id"=>"M7159", "name"=>"Diarrhea", "relevance"=>"LOW"}, {"id"=>"M7913", "name"=>"Enteritis", "asFound"=>"Enteritis", "relevance"=>"HIGH"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M6668", "name"=>"Cryptosporidiosis", "asFound"=>"Cryptosporidiosis", "relevance"=>"HIGH"}, {"id"=>"M8875", "name"=>"Gastroenteritis", "relevance"=>"LOW"}, {"id"=>"M8883", "name"=>"Gastrointestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M7255", "name"=>"Digestive System Diseases", "relevance"=>"LOW"}, {"id"=>"M10444", "name"=>"Intestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M10445", "name"=>"Intestinal Diseases, Parasitic", "relevance"=>"LOW"}, {"id"=>"M13185", "name"=>"Parasitic Diseases", "relevance"=>"LOW"}, {"id"=>"M14388", "name"=>"Protozoan Infections", "relevance"=>"LOW"}, {"id"=>"M6276", "name"=>"Coccidioidomycosis", "relevance"=>"LOW"}, {"id"=>"M6277", "name"=>"Coccidiosis", "relevance"=>"LOW"}, {"id"=>"T1672", "name"=>"Cryptosporidiosis", "asFound"=>"Cryptosporidiosis", "relevance"=>"HIGH"}, {"id"=>"T1374", "name"=>"Coccidioidomycosis", "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"=>"Digestive System Diseases", "abbrev"=>"BC06"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M4225", "name"=>"Antibodies", "relevance"=>"LOW"}, {"id"=>"M10184", "name"=>"Immunoglobulins", "relevance"=>"LOW"}, {"id"=>"M19117", "name"=>"Immunoglobulins, Intravenous", "relevance"=>"LOW"}, {"id"=>"M11139", "name"=>"Loperamide", "relevance"=>"LOW"}, {"id"=>"M4249", "name"=>"Antidiarrheals", "relevance"=>"LOW"}, {"id"=>"T435", "name"=>"Whey Protein", "asFound"=>"Vial", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Gastrointestinal Agents", "abbrev"=>"Gast"}, {"name"=>"Other Dietary Supplements", "abbrev"=>"Ot"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"maskingInfo"=>{"masking"=>"DOUBLE"}, "primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>40}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1993-04", "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"=>["Antidiarrheals", "Cryptosporidiosis", "Diarrhea", "Acquired Immunodeficiency Syndrome", "Cryptosporidium", "Immunization, Passive"], "conditions"=>["Cryptosporidiosis", "HIV Infections"]}, "referencesModule"=>{"references"=>[{"type"=>"BACKGROUND", "citation"=>"Nord J, Ma P, Tacket CO, Dijohn D, Tzipori S, Sahner D, Shieb G. Treatment of AIDS associated cryptosporidiosis with hyperimmune colostrum from cows vaccinated with cryptosporidium. Int Conf AIDS. 1989 Jun 4-9;5:656 (abstract no C586)"}]}, "descriptionModule"=>{"briefSummary"=>"PRIMARY: To assess the effect of bovine anti-Cryptosporidium immunoglobulin (BACI) on the volume of diarrhea due to Cryptosporidium parvum in AIDS patients who have protracted Cryptosporidium enteritis.\n\nSECONDARY: To assess changes in stool consistency and frequency, body weight, and safety in this patient population.", "detailedDescription"=>"Forty patients are randomized to receive either BACI or placebo (bovine colostrum from non-immunized cattle) for 1 week. The double-blind portion of the study will be followed by an open-label phase in which all 40 patients receive BACI for 1 week."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Antidiarrheal compounds (if dose remains stable).\n* Zidovudine (AZT), dideoxyinosine (ddI), dideoxycytidine (ddC), or alternative HIV therapy (provided dose was stable for at least 4 weeks prior to study entry).\n\nPatients must have:\n\n* AIDS.\n* Cryptosporidium parvum enteritis.\n* Chronic diarrhea.\n* Life expectancy of at least 4 weeks.\n* Ability to tolerate food by mouth.\n* Ability to take the histamine H2-receptor antagonist famotidine (Pepcid).\n\nPrior Medication:\n\nAllowed:\n\n* Antidiarrheal compounds (provided dose has remained stable in the 7 days prior to study entry).\n* Zidovudine (AZT), dideoxyinosine (ddI), dideoxycytidine (ddC), or alternative HIV therapy (provided dose has remained stable for at least 4 weeks prior to study entry).\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\n* Concurrent unresolved clinical infections with enteric pathogens other than C. parvum (e.g., rotavirus, Salmonella, Shigella, Campylobacter, Giardia, C. difficile toxin, Yersinia, amebiasis, MAI, CMV, Microsporida) as determined by history or routine microbiology screening.\n* Other acute infections or concurrent immediately life-threatening medical crisis other than cryptosporidiosis.\n* Grossly bloody diarrhea.\n* Known allergy to milk or milk products (other than lactose intolerance).\n\nPrior Medication:\n\nExcluded:\n\n* Other experimental therapy (e.g., macrolide antibiotics, paromomycin) within 30 days prior to study entry."}, "identificationModule"=>{"nctId"=>"NCT00002248", "briefTitle"=>"A Randomized, Multicenter, Double-Blind, Parallel-Group, Placebo-Controlled Trial of the Efficacy and Safety of Bovine Anti-Cryptosporidium Immunoglobulin (BACI) in the Treatment of Cryptosporidium Enteritis in AIDS Patients", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"NIH AIDS Clinical Trials Information Service"}, "officialTitle"=>"A Randomized, Multicenter, Double-Blind, Parallel-Group, Placebo-Controlled Trial of the Efficacy and Safety of Bovine Anti-Cryptosporidium Immunoglobulin (BACI) in the Treatment of Cryptosporidium Enteritis in AIDS Patients", "orgStudyIdInfo"=>{"id"=>"081A"}, "secondaryIdInfos"=>[{"id"=>"UNX-4101"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Cryptosporidium Immune Whey Protein Concentrate (Bovine)", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"90067", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"Gabin Med Group", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"94110", "city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"UCSF - San Francisco Gen Hosp", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"30308", "city"=>"Atlanta", "state"=>"Georgia", "country"=>"United States", "facility"=>"AIDS Research Consortium of Atlanta", "geoPoint"=>{"lat"=>33.749, "lon"=>-84.38798}}, {"zip"=>"02111", "city"=>"Boston", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"New England Med Ctr", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}, {"zip"=>"02135", "city"=>"Boston", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Saint Elizabeth's Hosp", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}, {"zip"=>"10021", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Cornell Univ Med Ctr", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Univax Biologics Inc", "class"=>"INDUSTRY"}}}}
