Nctid:
NCT00000991
Payload:
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{"InterventionAncestorId"=>"D000000977", "InterventionAncestorTerm"=>"Antiparasitic Agents"}, {"InterventionAncestorId"=>"D000005493", "InterventionAncestorTerm"=>"Folic Acid Antagonists"}, {"InterventionAncestorId"=>"D000018726", "InterventionAncestorTerm"=>"Anti-Dyskinesia Agents"}, {"InterventionAncestorId"=>"D000065687", "InterventionAncestorTerm"=>"Cytochrome P-450 CYP2C8 Inhibitors"}, {"InterventionAncestorId"=>"D000065607", "InterventionAncestorTerm"=>"Cytochrome P-450 Enzyme Inhibitors"}, {"InterventionAncestorId"=>"D000007917", "InterventionAncestorTerm"=>"Leprostatic Agents"}, {"InterventionAncestorId"=>"D000000900", "InterventionAncestorTerm"=>"Anti-Bacterial Agents"}, {"InterventionAncestorId"=>"D000000935", "InterventionAncestorTerm"=>"Antifungal Agents"}, {"InterventionAncestorId"=>"D000014344", "InterventionAncestorTerm"=>"Trypanocidal Agents"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M6514", "InterventionBrowseLeafName"=>"Dapsone", "InterventionBrowseLeafAsFound"=>"Notification", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M17943", "InterventionBrowseLeafName"=>"Trimethoprim, Sulfamethoxazole Drug Combination", "InterventionBrowseLeafAsFound"=>"Tildrakizumab", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M16737", "InterventionBrowseLeafName"=>"Trimethoprim", "InterventionBrowseLeafAsFound"=>"Whey", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M15896", "InterventionBrowseLeafName"=>"Sulfamethoxazole", "InterventionBrowseLeafAsFound"=>"Fractions of", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M17610", "InterventionBrowseLeafName"=>"Zidovudine", "InterventionBrowseLeafAsFound"=>"A 2-", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M13020", "InterventionBrowseLeafName"=>"Pentamidine", "InterventionBrowseLeafAsFound"=>"Telemetry", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M3971", "InterventionBrowseLeafName"=>"Antimetabolites", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M20625", "InterventionBrowseLeafName"=>"Reverse Transcriptase Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M7641", "InterventionBrowseLeafName"=>"Enzyme Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M4004", "InterventionBrowseLeafName"=>"Antiviral Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3904", "InterventionBrowseLeafName"=>"Anti-Infective Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M21040", "InterventionBrowseLeafName"=>"Anti-HIV Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M25118", "InterventionBrowseLeafName"=>"Anti-Retroviral Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3970", "InterventionBrowseLeafName"=>"Antimalarials", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3988", "InterventionBrowseLeafName"=>"Antiprotozoal Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3984", "InterventionBrowseLeafName"=>"Antiparasitic Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M17236", "InterventionBrowseLeafName"=>"Vitamin B Complex", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M8308", "InterventionBrowseLeafName"=>"Folic Acid", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M8309", "InterventionBrowseLeafName"=>"Folic Acid Antagonists", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M30227", "InterventionBrowseLeafName"=>"Cytochrome P-450 Enzyme Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3912", "InterventionBrowseLeafName"=>"Anti-Bacterial Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3944", "InterventionBrowseLeafName"=>"Antifungal Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M5942", "InterventionBrowseLeafName"=>"Clotrimazole", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M11486", "InterventionBrowseLeafName"=>"Miconazole", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"T448", "InterventionBrowseLeafName"=>"Folate", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"T447", "InterventionBrowseLeafName"=>"Folinic Acid", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"T446", "InterventionBrowseLeafName"=>"Folic Acid", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"T475", "InterventionBrowseLeafName"=>"Vitamin B9", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Anti-Infective Agents", "InterventionBrowseBranchAbbrev"=>"Infe"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}, {"InterventionBrowseBranchName"=>"Anti-Dyskinesia Agents", "InterventionBrowseBranchAbbrev"=>"AnDyAg"}, {"InterventionBrowseBranchName"=>"Micronutrients", "InterventionBrowseBranchAbbrev"=>"Micro"}, {"InterventionBrowseBranchName"=>"Hematinics", "InterventionBrowseBranchAbbrev"=>"Hemat"}, {"InterventionBrowseBranchName"=>"Vitamins", "InterventionBrowseBranchAbbrev"=>"Vi"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 3"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignMaskingInfo"=>{"DesignMasking"=>"None (Open Label)"}, "DesignPrimaryPurpose"=>"Treatment"}, "EnrollmentInfo"=>{"EnrollmentCount"=>"600"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"October 2021", "CompletionDateStruct"=>{"CompletionDate"=>"April 1994", "CompletionDateType"=>"Actual"}, "LastUpdateSubmitDate"=>"October 28, 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"=>["Trimethoprim-Sulfamethoxazole Combination", "Toxoplasmosis", "AIDS-Related Opportunistic Infections", "Pneumonia, Pneumocystis carinii", "Pentamidine", "Dapsone", "Drug Evaluation", "Drug Therapy, Combination", "Acquired Immunodeficiency Syndrome", "Zidovudine", "Sulfamethoxazole-Trimethoprim"]}, "ConditionList"=>{"Condition"=>["Pneumonia, Pneumocystis Carinii", "HIV Infections"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"8028406", "ReferenceType"=>"background", "ReferenceCitation"=>"Bozzette SA, Hays RD, Berry SH, Kanouse DE. A Perceived Health Index for use in persons with advanced HIV disease: derivation, reliability, and validity. Med Care. 1994 Jul;32(7):716-31. doi: 10.1097/00005650-199407000-00005."}, {"ReferencePMID"=>"7854375", "ReferenceType"=>"background", "ReferenceCitation"=>"Bozzette SA, Finkelstein DM, Spector SA, Frame P, Powderly WG, He W, Phillips L, Craven D, van der Horst C, Feinberg J. A randomized trial of three antipneumocystis agents in patients with advanced human immunodeficiency virus infection. NIAID AIDS Clinical Trials Group. N Engl J Med. 1995 Mar 16;332(11):693-9. doi: 10.1056/NEJM199503163321101."}, {"ReferencePMID"=>"11362451", "ReferenceType"=>"background", "ReferenceCitation"=>"Glick ME. CTG studies yield results. AIDS Clinical Trials Group. NIAID AIDS Agenda. 1995 Spring:8-9."}, {"ReferencePMID"=>"10360804", "ReferenceType"=>"background", "ReferenceCitation"=>"Justice AC, Rabeneck L, Hays RD, Wu AW, Bozzette SA. Sensitivity, specificity, reliability, and clinical validity of provider-reported symptoms: a comparison with self-reported symptoms. Outcomes Committee of the AIDS Clinical Trials Group. J Acquir Immune Defic Syndr. 1999 Jun 1;21(2):126-33."}, {"ReferencePMID"=>"11750213", "ReferenceType"=>"background", "ReferenceCitation"=>"Justice AC, Holmes W, Gifford AL, Rabeneck L, Zackin R, Sinclair G, Weissman S, Neidig J, Marcus C, Chesney M, Cohn SE, Wu AW; Adult AIDS Clinical Trials Unit Outcomes Committee. Development and validation of a self-completed HIV symptom index. J Clin Epidemiol. 2001 Dec;54 Suppl 1:S77-90. doi: 10.1016/s0895-4356(01)00449-8."}, {"ReferencePMID"=>"10357498", "ReferenceType"=>"background", "ReferenceCitation"=>"Ioannidis JP, Dixon DO, McIntosh M, Albert JM, Bozzette SA, Schnittman SM. Relationship between event rates and treatment effects in clinical site differences within multicenter trials: an example from primary Pneumocystis carinii prophylaxis. Control Clin Trials. 1999 Jun;20(3):253-66. doi: 10.1016/s0197-2456(98)00053-1."}, {"ReferencePMID"=>"11839141", "ReferenceType"=>"background", "ReferenceCitation"=>"DiRienzo AG, van Der Horst C, Finkelstein DM, Frame P, Bozzette SA, Tashima KT. Efficacy of trimethoprim-sulfamethoxazole for the prevention of bacterial infections in a randomized prophylaxis trial of patients with advanced HIV infection. AIDS Res Hum Retroviruses. 2002 Jan 20;18(2):89-94. doi: 10.1089/08892220252779629."}]}}, "DescriptionModule"=>{"BriefSummary"=>"To evaluate and compare 3 anti-pneumocystis regimens plus zidovudine (AZT) in persons with HIV infection and T4 cell count less than 200 cells/mm3. All persons completing at least 8 weeks of therapy on 081 will be offered the opportunity to participate in the nested study (ACTG 981) of systemic antifungal therapy (fluconazole) versus local therapy (Clotrimazole) for the prevention of serious fungal disease.\n\nPersons with HIV disease who are receiving AZT are at risk for PCP, toxoplasmosis, bacterial pneumonia, and other serious infections. It is therefore important to find drugs that can be given along with AZT to control these infections. Aerosolized pentamidine (PEN) has been shown to be useful in preventing PCP and is expected to lower the 2-year risk of PCP. Both sulfamethoxazole/trimethoprim (SMX/TMP) and dapsone probably also provide effective preventive treatment against PCP, and both may be useful in preventing toxoplasmosis and extrapulmonary pneumocystosis.", "DetailedDescription"=>"Persons with HIV disease who are receiving AZT are at risk for PCP, toxoplasmosis, bacterial pneumonia, and other serious infections. It is therefore important to find drugs that can be given along with AZT to control these infections. Aerosolized pentamidine (PEN) has been shown to be useful in preventing PCP and is expected to lower the 2-year risk of PCP. Both sulfamethoxazole/trimethoprim (SMX/TMP) and dapsone probably also provide effective preventive treatment against PCP, and both may be useful in preventing toxoplasmosis and extrapulmonary pneumocystosis.\n\nAll patients receive AZT. In addition, they are placed in one of three groups to receive either SMX/TMP, dapsone, or PEN. Stratification criteria are:\n\nReceived first AZT equal to or less than 6 weeks prior to study entry. Received first AZT more than 6 weeks prior to study entry. Potential to participate in ACTG 981. ACTG center in which the patient is enrolled."}, "EligibilityModule"=>{"Gender"=>"All", "MinimumAge"=>"13 years", "StdAgeList"=>{"StdAge"=>["Child", "Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\nAntifolate medication required to treat an intercurrent infection.\nTreatment of intercurrent infections or malignancies.\nFluconazole.\nItraconazole.\nStandard or investigational therapy for pneumocystosis (PCP) or toxoplasmosis.\nOnly the forms of primary prophylaxis for PCP or toxoplasmosis assigned to the participant under the protocol. Patients who develop intolerance to all forms of prophylaxis assigned in this protocol or who develop PCP or toxoplasmosis may receive alternate or investigation forms of prophylaxis with or without zidovudine but must continue to be followed under this protocol.\nDiscouraged but allowed: AL-721.\nChronic acyclovir.\nKetoconazole.\nAmphotericin B.\nCorticosteroids at greater than physiologic replacement doses are strongly discouraged.\nThey should be used as briefly as possible and only for definite specific indications.\n\nPatient must conform to the following:\n\nReceiving or candidates for zidovudine therapy at least 500 mg/day under current labeled indications with no history of pneumocystosis (PCP) or toxoplasmosis.\nEvidence of HIV infection documented by HIV antibody tests.\nT4 cell count less than 200 cells/mm3 at any time prior to study entry.\nWilling to sign informed consent.\nWilling to be followed by a participating ACTG center for duration of the study.\nAllowed: Concurrent enrollment in long-term follow-up studies in previously blinded trials of AZT (ACTG 016 and 019).\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following conditions are excluded:\n\nHistory of documented or presumed pneumocystosis (PCP) or toxoplasmosis.\nActive bacterial or mycobacterial infection.\nHistory of type I hypersensitivity, exfoliative rash, or rash with mucosal involvement, severe bronchospasm, or other life-threatening reaction to any of the study drugs or to other sulfas, sulfones, or pentamidine.\nHistory of intolerance causing dose interruption while receiving zidovudine at equal to or less than 600 mg/day or causing dose reduction to less than 500 mg/day within 4 weeks prior to entry.\nAdvanced Kaposi's sarcoma or other malignancy not specifically allowed that has been rapidly progressive during the month prior to enrollment or which may be expected to require chemotherapy within 90 days of study entry.\n\nConcurrent Medication:\n\nExcluded:\n\nActive primary treatment for an infection or malignancy.\nOther form of antifolate medication not specifically allowed.\nOther antiretroviral or biologic response modifier.\nGanciclovir, if it causes intolerance to AZT equal to or more than 500 mg/day.\nFoscarnet.\n\nPatients with the following are excluded:\n\nSymptoms and conditions defined in Exclusion Coexisting Conditions.\nGlucose 6-phosphate dehydrogenase deficiency (GPD).\nHistory of pneumocystosis (PCP) or toxoplasmosis.\nHistory of type I hypersensitivity, exfoliative rash, or rash with mucosal involvement, severe bronchospasm, or other life-threatening reaction to any of the study drugs or to other sulfas, sulfones, or pentamidine.\nHistory of intolerance causing dose interruption while receiving zidovudine at equal to or less than 500 mg/day with 4 weeks pior to study entry.\n\nPrior Medication:\n\nExcluded within 4 weeks of study entry:\n\nAny other form of pneumocystosis (PCP) chemoprophylaxis.\nActive substance abuse, including alcohol."}, "IdentificationModule"=>{"NCTId"=>"NCT00000991", "BriefTitle"=>"A Study of Three Drugs Plus Zidovudine in the Prevention of Infections in HIV-Infected Patients", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "OfficialTitle"=>"A Randomized Trial of Three Anti-Pneumocystis Agents Plus Zidovudine for the Primary Prevention of Serious Infections in Patients With Advanced HIV Infection", "OrgStudyIdInfo"=>{"OrgStudyId"=>"ACTG 081"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"11056", "SecondaryIdType"=>"Registry Identifier", "SecondaryIdDomain"=>"DAIDS ES Registry Number"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Pentamidine isethionate", "InterventionType"=>"Drug"}, {"InterventionName"=>"Sulfamethoxazole-Trimethoprim", "InterventionType"=>"Drug"}, {"InterventionName"=>"Dapsone", "InterventionType"=>"Drug"}, {"InterventionName"=>"Zidovudine", "InterventionType"=>"Drug"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"90033", "LocationCity"=>"Los Angeles", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"USC CRS"}, {"LocationZip"=>"94609", "LocationCity"=>"Oakland", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab."}, {"LocationZip"=>"92103", "LocationCity"=>"San Diego", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"Ucsd, Avrc Crs"}, {"LocationZip"=>"33136", "LocationCity"=>"Miami", "LocationState"=>"Florida", "LocationCountry"=>"United States", "LocationFacility"=>"Univ. of Miami AIDS CRS"}, {"LocationZip"=>"60614", "LocationCity"=>"Chicago", "LocationState"=>"Illinois", "LocationCountry"=>"United States", "LocationFacility"=>"Chicago Children's CRS"}, {"LocationZip"=>"46202", "LocationCity"=>"Indianapolis", "LocationState"=>"Indiana", "LocationCountry"=>"United States", "LocationFacility"=>"Indiana Univ. School of Medicine, Infectious Disease Research Clinic"}, {"LocationZip"=>"21287", "LocationCity"=>"Baltimore", "LocationState"=>"Maryland", "LocationCountry"=>"United States", "LocationFacility"=>"Johns Hopkins Adult AIDS CRS"}, {"LocationZip"=>"02114", "LocationCity"=>"Boston", "LocationState"=>"Massachusetts", "LocationCountry"=>"United States", "LocationFacility"=>"Massachusetts General Hospital ACTG CRS"}, {"LocationZip"=>"02215", "LocationCity"=>"Boston", "LocationState"=>"Massachusetts", "LocationCountry"=>"United States", "LocationFacility"=>"Beth Israel Deaconess - East Campus A0102 CRS"}, {"LocationZip"=>"02215", "LocationCity"=>"Boston", "LocationState"=>"Massachusetts", "LocationCountry"=>"United States", "LocationFacility"=>"Beth Israel Deaconess Med. Ctr., ACTG CRS"}, {"LocationZip"=>"55455", "LocationCity"=>"Minneapolis", "LocationState"=>"Minnesota", "LocationCountry"=>"United States", "LocationFacility"=>"University of Minnesota, ACTU"}, {"LocationCity"=>"Saint Louis", "LocationState"=>"Missouri", "LocationCountry"=>"United States", "LocationFacility"=>"Washington U CRS"}, {"LocationZip"=>"14215", "LocationCity"=>"Buffalo", "LocationState"=>"New York", "LocationCountry"=>"United States", "LocationFacility"=>"SUNY - Buffalo, Erie County Medical Ctr."}, {"LocationCity"=>"Rochester", "LocationState"=>"New York", "LocationCountry"=>"United States", "LocationFacility"=>"Univ. of Rochester ACTG CRS"}, {"LocationCity"=>"Chapel Hill", "LocationState"=>"North Carolina", "LocationCountry"=>"United States", "LocationFacility"=>"Unc Aids Crs"}, {"LocationCity"=>"Durham", "LocationState"=>"North Carolina", "LocationCountry"=>"United States", "LocationFacility"=>"Duke Univ. Med. Ctr. Adult CRS"}, {"LocationZip"=>"44106", "LocationCity"=>"Cleveland", "LocationState"=>"Ohio", "LocationCountry"=>"United States", "LocationFacility"=>"Case CRS"}, {"LocationZip"=>"43210", "LocationCity"=>"Columbus", "LocationState"=>"Ohio", "LocationCountry"=>"United States", "LocationFacility"=>"The Ohio State Univ. AIDS CRS"}, {"LocationCity"=>"Pittsburgh", "LocationState"=>"Pennsylvania", "LocationCountry"=>"United States", "LocationFacility"=>"Pitt CRS"}, {"LocationZip"=>"98105", "LocationCity"=>"Seattle", "LocationState"=>"Washington", "LocationCountry"=>"United States", "LocationFacility"=>"University of Washington AIDS CRS"}, {"LocationCity"=>"Mbeya", "LocationCountry"=>"Tanzania", "LocationFacility"=>"Mbeya Med. Research Program, Mbeya Referral Hosp. CRS"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"S Bozzette", "OverallOfficialRole"=>"Study Chair"}, {"OverallOfficialName"=>"S Spector", "OverallOfficialRole"=>"Study Chair"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "LeadSponsorClass"=>"NIH"}, "ResponsibleParty"=>{"ResponsiblePartyType"=>"Sponsor"}}}}}}
