Nctid:
NCT00000794
Payload:
{"FullStudy"=>{"Rank"=>473610, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"November 27, 2023", "RemovedCountryList"=>{"RemovedCountry"=>["France"]}}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000014123", "ConditionMeshTerm"=>"Toxoplasmosis"}, {"ConditionMeshId"=>"D000016781", "ConditionMeshTerm"=>"Toxoplasmosis, Cerebral"}, {"ConditionMeshId"=>"D000004660", "ConditionMeshTerm"=>"Encephalitis"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000007239", "ConditionAncestorTerm"=>"Infections"}, {"ConditionAncestorId"=>"D000001927", "ConditionAncestorTerm"=>"Brain Diseases"}, {"ConditionAncestorId"=>"D000002493", "ConditionAncestorTerm"=>"Central Nervous System Diseases"}, {"ConditionAncestorId"=>"D000009422", "ConditionAncestorTerm"=>"Nervous System Diseases"}, {"ConditionAncestorId"=>"D000090862", "ConditionAncestorTerm"=>"Neuroinflammatory Diseases"}, {"ConditionAncestorId"=>"D000003048", "ConditionAncestorTerm"=>"Coccidiosis"}, {"ConditionAncestorId"=>"D000011528", "ConditionAncestorTerm"=>"Protozoan Infections"}, {"ConditionAncestorId"=>"D000010272", "ConditionAncestorTerm"=>"Parasitic Diseases"}, {"ConditionAncestorId"=>"D000001922", "ConditionAncestorTerm"=>"Brain Abscess"}, {"ConditionAncestorId"=>"D000002494", "ConditionAncestorTerm"=>"Central Nervous System Infections"}, {"ConditionAncestorId"=>"D000020808", "ConditionAncestorTerm"=>"Central Nervous System Protozoal Infections"}, {"ConditionAncestorId"=>"D000020807", "ConditionAncestorTerm"=>"Central Nervous System Parasitic Infections"}, {"ConditionAncestorId"=>"D000000038", "ConditionAncestorTerm"=>"Abscess"}, {"ConditionAncestorId"=>"D000013492", "ConditionAncestorTerm"=>"Suppuration"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M16045", "ConditionBrowseLeafName"=>"Syndrome", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M9973", "ConditionBrowseLeafName"=>"Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M6058", "ConditionBrowseLeafName"=>"Communicable Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M9889", "ConditionBrowseLeafName"=>"Immunologic Deficiency Syndromes", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M17940", "ConditionBrowseLeafName"=>"HIV Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M3212", "ConditionBrowseLeafName"=>"Acquired Immunodeficiency Syndrome", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M7515", "ConditionBrowseLeafName"=>"Encephalitis", "ConditionBrowseLeafAsFound"=>"Encephalitis", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M16567", "ConditionBrowseLeafName"=>"Toxoplasmosis", "ConditionBrowseLeafAsFound"=>"Toxoplasmosis", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M18826", "ConditionBrowseLeafName"=>"Toxoplasmosis, Cerebral", "ConditionBrowseLeafAsFound"=>"Toxoplasmosis, Cerebral", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M4894", "ConditionBrowseLeafName"=>"Brain Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M5432", "ConditionBrowseLeafName"=>"Central Nervous System Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M2804", "ConditionBrowseLeafName"=>"Neuroinflammatory Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M5966", "ConditionBrowseLeafName"=>"Coccidioidomycosis", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M5967", "ConditionBrowseLeafName"=>"Coccidiosis", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M14078", "ConditionBrowseLeafName"=>"Protozoan Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M12875", "ConditionBrowseLeafName"=>"Parasitic Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M37", "ConditionBrowseLeafName"=>"Abscess", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4889", "ConditionBrowseLeafName"=>"Brain Abscess", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M5433", "ConditionBrowseLeafName"=>"Central Nervous System Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M15963", "ConditionBrowseLeafName"=>"Suppuration", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"T170", "ConditionBrowseLeafName"=>"Acute Graft Versus Host Disease", "ConditionBrowseLeafRelevance"=>"low"}, {"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"=>"Immune System Diseases", "ConditionBrowseBranchAbbrev"=>"BC20"}, {"ConditionBrowseBranchName"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "ConditionBrowseBranchAbbrev"=>"BXS"}, {"ConditionBrowseBranchName"=>"Nervous System Diseases", "ConditionBrowseBranchAbbrev"=>"BC10"}, {"ConditionBrowseBranchName"=>"Rare Diseases", "ConditionBrowseBranchAbbrev"=>"Rare"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"D000002955", "InterventionMeshTerm"=>"Leucovorin"}, {"InterventionMeshId"=>"D000017291", "InterventionMeshTerm"=>"Clarithromycin"}, {"InterventionMeshId"=>"D000013411", "InterventionMeshTerm"=>"Sulfadiazine"}, {"InterventionMeshId"=>"D000011739", "InterventionMeshTerm"=>"Pyrimethamine"}, {"InterventionMeshId"=>"D000053626", "InterventionMeshTerm"=>"Atovaquone"}, {"InterventionMeshId"=>"D000002118", "InterventionMeshTerm"=>"Calcium"}, {"InterventionMeshId"=>"D000058766", "InterventionMeshTerm"=>"Levoleucovorin"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000077264", "InterventionAncestorTerm"=>"Calcium-Regulating Hormones and Agents"}, {"InterventionAncestorId"=>"D000045505", "InterventionAncestorTerm"=>"Physiological Effects of Drugs"}, {"InterventionAncestorId"=>"D000000931", "InterventionAncestorTerm"=>"Antidotes"}, {"InterventionAncestorId"=>"D000020011", "InterventionAncestorTerm"=>"Protective Agents"}, {"InterventionAncestorId"=>"D000014803", "InterventionAncestorTerm"=>"Vitamin B Complex"}, {"InterventionAncestorId"=>"D000014815", "InterventionAncestorTerm"=>"Vitamins"}, {"InterventionAncestorId"=>"D000018977", "InterventionAncestorTerm"=>"Micronutrients"}, {"InterventionAncestorId"=>"D000000900", "InterventionAncestorTerm"=>"Anti-Bacterial Agents"}, {"InterventionAncestorId"=>"D000000890", "InterventionAncestorTerm"=>"Anti-Infective Agents"}, {"InterventionAncestorId"=>"D000011500", "InterventionAncestorTerm"=>"Protein Synthesis Inhibitors"}, {"InterventionAncestorId"=>"D000004791", "InterventionAncestorTerm"=>"Enzyme Inhibitors"}, {"InterventionAncestorId"=>"D000045504", "InterventionAncestorTerm"=>"Molecular Mechanisms of Pharmacological Action"}, {"InterventionAncestorId"=>"D000065692", "InterventionAncestorTerm"=>"Cytochrome P-450 CYP3A Inhibitors"}, {"InterventionAncestorId"=>"D000065607", "InterventionAncestorTerm"=>"Cytochrome P-450 Enzyme Inhibitors"}, {"InterventionAncestorId"=>"D000000962", "InterventionAncestorTerm"=>"Antimalarials"}, {"InterventionAncestorId"=>"D000000981", "InterventionAncestorTerm"=>"Antiprotozoal Agents"}, {"InterventionAncestorId"=>"D000000977", "InterventionAncestorTerm"=>"Antiparasitic Agents"}, {"InterventionAncestorId"=>"D000005493", "InterventionAncestorTerm"=>"Folic Acid Antagonists"}, {"InterventionAncestorId"=>"D000003049", "InterventionAncestorTerm"=>"Coccidiostats"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M5071", "InterventionBrowseLeafName"=>"Calcium", "InterventionBrowseLeafAsFound"=>"Double-blind", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M5881", "InterventionBrowseLeafName"=>"Leucovorin", "InterventionBrowseLeafAsFound"=>"2 weeks", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M5088", "InterventionBrowseLeafName"=>"Calcium, Dietary", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M28923", "InterventionBrowseLeafName"=>"Levoleucovorin", "InterventionBrowseLeafAsFound"=>"Absence of disease", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M19275", "InterventionBrowseLeafName"=>"Clarithromycin", "InterventionBrowseLeafAsFound"=>"Pharmacodynamics", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M14281", "InterventionBrowseLeafName"=>"Pyrimethamine", "InterventionBrowseLeafAsFound"=>"Requirements", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M27068", "InterventionBrowseLeafName"=>"Atovaquone", "InterventionBrowseLeafAsFound"=>"Morphine sulfate", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M15887", "InterventionBrowseLeafName"=>"Sulfadiazine", "InterventionBrowseLeafAsFound"=>"Total Thyroidectomy", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M3988", "InterventionBrowseLeafName"=>"Antiprotozoal Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M9479", "InterventionBrowseLeafName"=>"Hormones", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3940", "InterventionBrowseLeafName"=>"Antidotes", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M21559", "InterventionBrowseLeafName"=>"Protective Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M17248", "InterventionBrowseLeafName"=>"Vitamins", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M8308", "InterventionBrowseLeafName"=>"Folic Acid", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M17236", "InterventionBrowseLeafName"=>"Vitamin B Complex", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M20699", "InterventionBrowseLeafName"=>"Micronutrients", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M16575", "InterventionBrowseLeafName"=>"Trace Elements", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3912", "InterventionBrowseLeafName"=>"Anti-Bacterial Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3904", "InterventionBrowseLeafName"=>"Anti-Infective Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M7641", "InterventionBrowseLeafName"=>"Enzyme Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M30254", "InterventionBrowseLeafName"=>"Cytochrome P-450 CYP3A Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M30227", "InterventionBrowseLeafName"=>"Cytochrome P-450 Enzyme Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3970", "InterventionBrowseLeafName"=>"Antimalarials", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3984", "InterventionBrowseLeafName"=>"Antiparasitic Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M8309", "InterventionBrowseLeafName"=>"Folic Acid Antagonists", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"T447", "InterventionBrowseLeafName"=>"Folinic Acid", "InterventionBrowseLeafAsFound"=>"Absence of disease", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"T446", "InterventionBrowseLeafName"=>"Folic Acid", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"T448", "InterventionBrowseLeafName"=>"Folate", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"T475", "InterventionBrowseLeafName"=>"Vitamin B9", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}, {"InterventionBrowseBranchName"=>"Micronutrients", "InterventionBrowseBranchAbbrev"=>"Micro"}, {"InterventionBrowseBranchName"=>"Bone Density Conservation Agents", "InterventionBrowseBranchAbbrev"=>"BDCA"}, {"InterventionBrowseBranchName"=>"Anti-Infective Agents", "InterventionBrowseBranchAbbrev"=>"Infe"}, {"InterventionBrowseBranchName"=>"Hematinics", "InterventionBrowseBranchAbbrev"=>"Hemat"}, {"InterventionBrowseBranchName"=>"Vitamins", "InterventionBrowseBranchAbbrev"=>"Vi"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 2"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignPrimaryPurpose"=>"Treatment", "DesignInterventionModel"=>"Parallel Assignment"}, "EnrollmentInfo"=>{"EnrollmentCount"=>"100"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"October 2021", "CompletionDateStruct"=>{"CompletionDate"=>"April 1998", "CompletionDateType"=>"Actual"}, "LastUpdateSubmitDate"=>"October 27, 2021", "StudyFirstSubmitDate"=>"November 2, 1999", "StudyFirstSubmitQCDate"=>"August 30, 2001", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"October 28, 2021", "LastUpdatePostDateType"=>"Actual"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"August 31, 2001", "StudyFirstPostDateType"=>"Estimate"}}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Pyrimethamine", "Leucovorin", "Drug Therapy, Combination", "Encephalitis", "Acquired Immunodeficiency Syndrome", "Antiprotozoal Agents", "Clarithromycin", "atovaquone", "Toxoplasmosis, Cerebral", "Sulfadiazine"]}, "ConditionList"=>{"Condition"=>["Toxoplasmosis, Cerebral", "HIV Infections"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"11941551", "ReferenceType"=>"background", "ReferenceCitation"=>"Chirgwin K, Hafner R, Leport C, Remington J, Andersen J, Bosler EM, Roque C, Rajicic N, McAuliffe V, Morlat P, Jayaweera DT, Vilde JL, Luft BJ. Randomized phase II trial of atovaquone with pyrimethamine or sulfadiazine for treatment of toxoplasmic encephalitis in patients with acquired immunodeficiency syndrome: ACTG 237/ANRS 039 Study. AIDS Clinical Trials Group 237/Agence Nationale de Recherche sur le SIDA, Essai 039. Clin Infect Dis. 2002 May 1;34(9):1243-50. doi: 10.1086/339551."}]}}, "DescriptionModule"=>{"BriefSummary"=>"To evaluate the efficacy, safety, and tolerance of atovaquone with either pyrimethamine or sulfadiazine in AIDS patients with toxoplasmic encephalitis.\n\nAIDS patients with toxoplasmic encephalitis who receive the standard therapy combination of sulfadiazine and pyrimethamine experience a high frequency of severe toxicity. Atovaquone, an antibiotic that has demonstrated efficacy against toxoplasmosis in animal models and in preclinical testing has been well tolerated, is now available as a suspension, which is more readily absorbed than the tablet form of the drug. The efficacy and safety of atovaquone in combination with sulfadiazine or pyrimethamine will be studied.", "DetailedDescription"=>"AIDS patients with toxoplasmic encephalitis who receive the standard therapy combination of sulfadiazine and pyrimethamine experience a high frequency of severe toxicity. Atovaquone, an antibiotic that has demonstrated efficacy against toxoplasmosis in animal models and in preclinical testing has been well tolerated, is now available as a suspension, which is more readily absorbed than the tablet form of the drug. The efficacy and safety of atovaquone in combination with sulfadiazine or pyrimethamine will be studied.\n\nSeventy patients are randomized to receive atovaquone with either pyrimethamine or sulfonamides for up to 48 weeks. Additionally, three cohorts of 10 patients each who have a history of treatment-limiting toxicity to pyrimethamine, sulfadiazine, or both drugs receive atovaquone plus the alternate drug or atovaquone plus clarithromycin. All patients receiving pyrimethamine also receive leucovorin protection.\n\nPER AMENDMENT 4/3/96:\n\nThe open treatment groups are: Atovaquone plus pyrimethamine for patients with acute toxoplasmic encephalitis who have no treatment limiting toxicity to pyrimethamine, and Atovaquone plus clarithromycin for patients with acute toxoplasmic encephalitis who have treatment limiting toxicity to both pyrimethamine and sulfadiazine. The following arms closed on 12/22/95: Randomization to the atovaquone plus sulfadiazine arm for patients with acute toxoplasmic encephalitis who had no treatment limiting toxicity to pyrimethamine or sulfonamides, and Atovaquone plus sulfadiazine for patients with acute toxoplasmic encephalitis who had treatment limiting toxicity to pyrimethamine. The following arm closed on 9/26/95: Atovaquone plus pyrimethamine for patients with acute toxoplasmic encephalitis who had treatment limiting toxicity to sulfonamides. NOTE: Any patients enrolled in previous versions will continue to be treated with that same drug treatment and followed under their previous version guidelines."}, "EligibilityModule"=>{"Gender"=>"All", "MinimumAge"=>"13 years", "StdAgeList"=>{"StdAge"=>["Child", "Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\nAerosolized pentamidine for PCP prophylaxis.\n\nPER AMENDMENT 4/3/96:\n\nHistory of treatment limiting toxicity to pyrimethamine. Patients with a history of treatment limiting toxicity to both pyrimethamine and sulfonamides will be assigned to receive atovaquone plus clarithromycin.\n\nPatients must have:\n\nDocumented HIV infection or diagnosis of AIDS (except for CD4 count < 200 cells/mm3).\nToxoplasmic encephalitis.\nAbility to give informed consent or legal designee who could give consent.\n\nPER AMENDMENT 4/3/96:\n\nNOTE - A history of treatment limiting toxicity to both pyrimethamine and sulfonamides will result in the patient being enrolled in the atovaquone plus clarithromycin arm.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\nComa.\nOpportunistic infection that requires either acute or maintenance treatment with disallowed medications.\nAny infections or neoplasms of the central nervous system other than Toxoplasma, HIV encephalopathy, or syphilis.\nUnable to take oral study drugs.\nMalabsorption (i.e., three or more episodes of diarrhea per day that has caused >= 10 percent loss of body weight over the past 4 weeks).\nPositive CSF or serum for Cryptococcus antigen or culture (a positive serum antigen only is acceptable, provided patient received prior antifungal therapy and is on maintenance, and the likelihood of recurrence is low).\nMalignancy requiring use of cytotoxic chemotherapy.\nMedical or social condition that would adversely affect study participation or compliance.\n\nConcurrent Medication:\n\nExcluded:\n\nTrimethoprim-sulfamethoxazole.\nPrimaquine.\nSulfonamides.\nAntifolates.\nDapsone.\nClarithromycin (except for patients in the cohort to receive this drug).\nAzithromycin.\nClindamycin.\nOther macrolides.\nGamma interferon.\nMetoclopramide.\nG-CSF or GM-CSF.\n\nExcluded in patients receiving clarithromycin as study drug:\n\nTerfenadine, astemizole, or any other long-acting, non-sedating antihistamines.\n\nPER AMENDMENT 4/3/96:\n\nCisapride - may increase GI motility and may increase drug absorption.\n\nPatients with the following prior conditions are excluded:\n\nHistory of treatment-limiting toxicity to atovaquone.\nReceipt of > 96 hours (per amendment) of treatment prior to study entry for the current episode of toxoplasmic encephalitis."}, "IdentificationModule"=>{"NCTId"=>"NCT00000794", "BriefTitle"=>"Phase II Randomized Open-Label Trial of Atovaquone Plus Pyrimethamine and Atovaquone Plus Sulfadiazine for the Treatment of Acute Toxoplasmic Encephalitis", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "OfficialTitle"=>"Phase II Randomized Open-Label Trial of Atovaquone Plus Pyrimethamine and Atovaquone Plus Sulfadiazine for the Treatment of Acute Toxoplasmic Encephalitis", "OrgStudyIdInfo"=>{"OrgStudyId"=>"ACTG 237"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"ANRS 039"}, {"SecondaryId"=>"11214", "SecondaryIdType"=>"Registry Identifier", "SecondaryIdDomain"=>"DAIDS-ES"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Sulfadiazine", "InterventionType"=>"Drug"}, {"InterventionName"=>"Clarithromycin", "InterventionType"=>"Drug"}, {"InterventionName"=>"Atovaquone", "InterventionType"=>"Drug"}, {"InterventionName"=>"Pyrimethamine", "InterventionType"=>"Drug"}, {"InterventionName"=>"Leucovorin calcium", "InterventionType"=>"Drug"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"900331079", "LocationCity"=>"Los Angeles", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"USC CRS"}, {"LocationZip"=>"331361013", "LocationCity"=>"Miami", "LocationState"=>"Florida", "LocationCountry"=>"United States", "LocationFacility"=>"Univ. of Miami AIDS CRS"}, {"LocationZip"=>"96816", "LocationCity"=>"Honolulu", "LocationState"=>"Hawaii", "LocationCountry"=>"United States", "LocationFacility"=>"Queens Med. Ctr."}, {"LocationZip"=>"96816", "LocationCity"=>"Honolulu", "LocationState"=>"Hawaii", "LocationCountry"=>"United States", "LocationFacility"=>"Univ. of Hawaii at Manoa, Leahi Hosp."}, {"LocationZip"=>"60611", "LocationCity"=>"Chicago", "LocationState"=>"Illinois", "LocationCountry"=>"United States", "LocationFacility"=>"Northwestern University CRS"}, {"LocationZip"=>"60612", "LocationCity"=>"Chicago", "LocationState"=>"Illinois", "LocationCountry"=>"United States", "LocationFacility"=>"Cook County Hosp. CORE Ctr."}, {"LocationZip"=>"462025250", "LocationCity"=>"Indianapolis", "LocationState"=>"Indiana", "LocationCountry"=>"United States", "LocationFacility"=>"Indiana Univ. School of Medicine, Infectious Disease Research Clinic"}, {"LocationZip"=>"46202", "LocationCity"=>"Indianapolis", "LocationState"=>"Indiana", "LocationCountry"=>"United States", "LocationFacility"=>"Methodist Hosp. of Indiana"}, {"LocationZip"=>"21287", "LocationCity"=>"Baltimore", "LocationState"=>"Maryland", "LocationCountry"=>"United States", "LocationFacility"=>"Johns Hopkins Adult AIDS CRS"}, {"LocationZip"=>"63110", "LocationCity"=>"Saint Louis", "LocationState"=>"Missouri", "LocationCountry"=>"United States", "LocationFacility"=>"Washington U CRS"}, {"LocationCity"=>"Saint Louis", "LocationState"=>"Missouri", "LocationCountry"=>"United States", "LocationFacility"=>"St. Louis ConnectCare, Infectious Diseases Clinic"}, {"LocationZip"=>"13210", "LocationCity"=>"Buffalo", "LocationState"=>"New York", "LocationCountry"=>"United States", "LocationFacility"=>"SUNY - Buffalo, Erie County Medical Ctr."}, {"LocationZip"=>"10003", "LocationCity"=>"New York", "LocationState"=>"New York", "LocationCountry"=>"United States", "LocationFacility"=>"Beth Israel Med. Ctr. (Mt. Sinai)"}, {"LocationCity"=>"New York", "LocationState"=>"New York", "LocationCountry"=>"United States", "LocationFacility"=>"NY Univ. HIV/AIDS CRS"}, {"LocationZip"=>"452670405", "LocationCity"=>"Cincinnati", "LocationState"=>"Ohio", "LocationCountry"=>"United States", "LocationFacility"=>"Univ. of Cincinnati CRS"}, {"LocationZip"=>"432101228", "LocationCity"=>"Columbus", "LocationState"=>"Ohio", "LocationCountry"=>"United States", "LocationFacility"=>"The Ohio State Univ. AIDS CRS"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Luft B", "OverallOfficialRole"=>"Study Chair"}, {"OverallOfficialName"=>"Chirgwin K", "OverallOfficialRole"=>"Study Chair"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "LeadSponsorClass"=>"NIH"}, "ResponsibleParty"=>{"ResponsiblePartyType"=>"Sponsor"}}}}}}
