Nctid:
NCT00000860
Payload:
{"FullStudy"=>{"Rank"=>498471, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"June 24, 2024"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000007239", "ConditionMeshTerm"=>"Infections"}, {"ConditionMeshId"=>"D000003141", "ConditionMeshTerm"=>"Communicable Diseases"}, {"ConditionMeshId"=>"D000009164", "ConditionMeshTerm"=>"Mycobacterium Infections"}, {"ConditionMeshId"=>"D000015270", "ConditionMeshTerm"=>"Mycobacterium avium-intracellulare Infection"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000020969", "ConditionAncestorTerm"=>"Disease Attributes"}, {"ConditionAncestorId"=>"D000010335", "ConditionAncestorTerm"=>"Pathologic Processes"}, {"ConditionAncestorId"=>"D000000193", "ConditionAncestorTerm"=>"Actinomycetales Infections"}, {"ConditionAncestorId"=>"D000016908", "ConditionAncestorTerm"=>"Gram-Positive Bacterial Infections"}, {"ConditionAncestorId"=>"D000001424", "ConditionAncestorTerm"=>"Bacterial Infections"}, {"ConditionAncestorId"=>"D000001423", "ConditionAncestorTerm"=>"Bacterial Infections and Mycoses"}, {"ConditionAncestorId"=>"D000009165", "ConditionAncestorTerm"=>"Mycobacterium Infections, Nontuberculous"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M10283", "ConditionBrowseLeafName"=>"Infections", "ConditionBrowseLeafAsFound"=>"Infection", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M6368", "ConditionBrowseLeafName"=>"Communicable Diseases", "ConditionBrowseLeafAsFound"=>"Infection", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M3522", "ConditionBrowseLeafName"=>"Acquired Immunodeficiency Syndrome", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M18250", "ConditionBrowseLeafName"=>"HIV Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M12284", "ConditionBrowseLeafName"=>"Necrosis", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M12119", "ConditionBrowseLeafName"=>"Mycobacterium Infections", "ConditionBrowseLeafAsFound"=>"Mycobacterium", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M17970", "ConditionBrowseLeafName"=>"Mycobacterium avium-intracellulare Infection", "ConditionBrowseLeafAsFound"=>"Mycobacterium avium-intracellulare Infection", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M12825", "ConditionBrowseLeafName"=>"Opportunistic Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M19410", "ConditionBrowseLeafName"=>"AIDS-Related Opportunistic Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M22700", "ConditionBrowseLeafName"=>"Disease Attributes", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4722", "ConditionBrowseLeafName"=>"Bacterial Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M19252", "ConditionBrowseLeafName"=>"Gram-Positive Bacterial Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M12136", "ConditionBrowseLeafName"=>"Mycoses", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4721", "ConditionBrowseLeafName"=>"Bacterial Infections and Mycoses", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M12120", "ConditionBrowseLeafName"=>"Mycobacterium Infections, Nontuberculous", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"T3977", "ConditionBrowseLeafName"=>"Mycobacterium Avium Complex Infections", "ConditionBrowseLeafAsFound"=>"Mycobacterium avium-intracellulare Infection", "ConditionBrowseLeafRelevance"=>"high"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Infections", "ConditionBrowseBranchAbbrev"=>"BC01"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Symptoms and General Pathology", "ConditionBrowseBranchAbbrev"=>"BC23"}, {"ConditionBrowseBranchName"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "ConditionBrowseBranchAbbrev"=>"BXS"}, {"ConditionBrowseBranchName"=>"Immune System Diseases", "ConditionBrowseBranchAbbrev"=>"BC20"}, {"ConditionBrowseBranchName"=>"Rare Diseases", "ConditionBrowseBranchAbbrev"=>"Rare"}]}}, "InterventionBrowseModule"=>{"InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M21350", "InterventionBrowseLeafName"=>"Anti-HIV Agents", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Anti-Infective Agents", "InterventionBrowseBranchAbbrev"=>"Infe"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"StudyType"=>"Observational", "DesignInfo"=>{"DesignObservationalModelList"=>{"DesignObservationalModel"=>["Natural History"]}}, "EnrollmentInfo"=>{"EnrollmentCount"=>"24"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"July 1999", "LastUpdateSubmitDate"=>"June 23, 2005", "StudyFirstSubmitDate"=>"November 2, 1999", "StudyFirstSubmitQCDate"=>"August 30, 2001", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"June 24, 2005", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"August 31, 2001", "StudyFirstPostDateType"=>"Estimate"}}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Tumor Necrosis Factor", "AIDS-Related Opportunistic Infections", "Mycobacterium avium-intracellulare Infection", "Drug Therapy, Combination", "Anti-HIV Agents"]}, "ConditionList"=>{"Condition"=>["Mycobacterium Avium-Intracellulare Infection", "HIV Infections"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferenceType"=>"background", "ReferenceCitation"=>"Benson CA. MAC: pathogenesis and treatment. Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:166"}, {"ReferencePMID"=>"10762582", "ReferenceType"=>"background", "ReferenceCitation"=>"MacArthur RD, Lederman MM, Benson CA, Chernoff MC, MacGregor RR, Spritzler J, Mahon LF, Yen-Lieberman B, Purvis S. Effects of Mycobacterium avium complex-infection treatment on cytokine expression in human immunodeficiency virus-infected persons: results of AIDS clinical trials group protocol 853. J Infect Dis. 2000 Apr;181(4):1486-90. doi: 10.1086/315370. Epub 2000 Apr 13."}, {"ReferenceType"=>"background", "ReferenceCitation"=>"MacArthur RD, Lederman M, Benson CA, Chernoff MC, Mahon LF, Yen-Lieberman B, Purvis S, MacGregor RR. ACTG 853: effects of treatment for MAC infection on cytokine expression in HIV-infected persons. Intersci Conf Antimicrob Agents Chemother. 1998 Sep 24-27;38:403 (abstract no I-130)"}]}}, "DescriptionModule"=>{"BriefSummary"=>"To determine if treatment of MAC infection in HIV-1 infected persons is associated with the decreases in plasma levels of TNF-alpha.\n\nInfection with MAC is a poor prognostic indicator in persons with AIDS. Evidence suggests that this poor outcome is not simply a reflection of greater immune impairment in AIDS patients with MAC infection, but rather may be a direct or indirect consequence of infection with mycobacterium. Survival of AIDS patients with MAC is shorter than those without MAC. Studies show that treatment for MAC improves the survival of MAC infected patients to nearly the survival of AIDS patients without MAC. Treatment of MAC with clarithromycin containing regimens is associated with decreased symptoms and prolonged survival. There is evidence, however, that mycobacterial infection may enhance propagation of the human immunodeficiency virus through mechanisms that may involve enhanced expression of pro inflammatory cytokines. It is unclear to what extent cytokine abnormalities contribute to this symptom complex and to what extent treatment of MAC infection will reverse these cytokine abnormalities.", "DetailedDescription"=>"Infection with MAC is a poor prognostic indicator in persons with AIDS. Evidence suggests that this poor outcome is not simply a reflection of greater immune impairment in AIDS patients with MAC infection, but rather may be a direct or indirect consequence of infection with mycobacterium. Survival of AIDS patients with MAC is shorter than those without MAC. Studies show that treatment for MAC improves the survival of MAC infected patients to nearly the survival of AIDS patients without MAC. Treatment of MAC with clarithromycin containing regimens is associated with decreased symptoms and prolonged survival. There is evidence, however, that mycobacterial infection may enhance propagation of the human immunodeficiency virus through mechanisms that may involve enhanced expression of pro inflammatory cytokines. It is unclear to what extent cytokine abnormalities contribute to this symptom complex and to what extent treatment of MAC infection will reverse these cytokine abnormalities.\n\nAll patients diagnosed with MAC and who will initiate at least a 2 drug clarithromycin containing MAC treatment regimen will be eligible for participation. Blood and urine will be obtained from each patient at the following timepoints: Pre-Entry (within 7 days prior to study entry), week 4, and week 8. Sites will process and ship specific samples to Case Western Reserve University (CWRU). Various assays and analyses will be performed by CWRU. NOTE: Patients will receive no treatment on this study, however, all patients must be receiving at least a 2 drug clarithromycin containing treatment regimen for MAC either as part of participation in other studies or as prescribed by the subject's health care provider."}, "EligibilityModule"=>{"Gender"=>"All", "MinimumAge"=>"13 years", "StdAgeList"=>{"StdAge"=>["Child", "Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\nPatients should have successfully completed therapy or be on stable therapy for any acute infectious processes other than MAC prior to study entry.\n\nPatients must have:\n\nDocumented HIV infection.\nEither symptomatic MAC disease as defined by a history of clinical signs and symptoms, plus one blood culture positive for MAC or AFB obtained within the previous 90 days, OR asymptomatic MAC disease as defined by 2 blood cultures positive for MAC or AFB obtained within 90 days of entry.\nSigned parental consent for patients less than 18 years of age.\n\nPrior Medication:\n\nAllowed:\n\nPatients who have received presumptive or empiric antimycobacterial therapy prior to study entry may be enrolled if they have been treated for no more than 72 hours prior to study entry.\nPatients who have been receiving prophylaxis with azithromycin, clarithromycin and/or rifabutin may be enrolled.\nPatients should have successfully completed therapy or be on stable therapy for any acute infectious processes other than MAC prior to study entry.\n\nRequired:\n\nPatients must be on a stable antiretroviral regimen (same drug or combination drugs; dose modifications allowed) for at least 4 weeks prior to study entry.\n\nNOTE:\n\nPatients will be requested NOT to modify or add new drugs to their stable ARV regimen for the duration of this study. Patients who absolutely require ARV changes at any time prior to week 8 will continue on study, however, their data will be analyzed separately.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\nPrevious enrollment and permanent study drug discontinuation in ACTG 223.\n\nNote:\n\nCo-enrollment in ACTG 223 and ACTG 853 is acceptable, however enrollment in both studies must be simultaneous.\nThis protocol does not meet federal requirements governing prisoner participation in clinical trials and should not be considered by local IRBs for the recruitment of prisoners.\n\nConcurrent Medication:\n\nExcluded:\n\nCytokine inhibitors.\nCorticosteroids.\nThalidomide.\nPentoxifylline or any other immunomodulator.\nAny interleukin.\nColony stimulating factors (G-CSF or GM-CSF)\n\nPatients with the following prior conditions will be excluded:\n\nSubjects who have had an opportunistic infection (other than MAC) within 14 days immediately preceding study entry.\n\nPrior Medication:\n\nExcluded within the 14 days immediately preceding study entry:\n\nCytokine inhibitors.\nCorticosteroids.\nThalidomide.\nPentoxifylline or any other immunomodulator.\nAny interleukin.\nColony stimulating factors (G-CSF or GM-CSF)\n\nPrior Treatment:\n\nExcluded:\n\nPatients who have received a blood transfusion within the 14 days immediately preceding study entry."}, "IdentificationModule"=>{"NCTId"=>"NCT00000860", "BriefTitle"=>"The Effects of Treatment for Mycobacterium Avium Complex (MAC) on the Cells of HIV-Infected Patients", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "OfficialTitle"=>"Effects of Treatment for MAC Infection on Cytokine Expression in HIV-Infected Persons.", "OrgStudyIdInfo"=>{"OrgStudyId"=>"ACTG 853"}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"941102859", "LocationCity"=>"San Francisco", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"San Francisco Gen Hosp"}, {"LocationZip"=>"80262", "LocationCity"=>"Denver", "LocationState"=>"Colorado", "LocationCountry"=>"United States", "LocationFacility"=>"Univ of Colorado Health Sciences Ctr"}, {"LocationZip"=>"20422", "LocationCity"=>"Washington", "LocationState"=>"District of Columbia", "LocationCountry"=>"United States", "LocationFacility"=>"Washington Reg AIDS Prog / Dept of Infect Dis"}, {"LocationZip"=>"60611", "LocationCity"=>"Chicago", "LocationState"=>"Illinois", "LocationCountry"=>"United States", "LocationFacility"=>"Northwestern Univ Med School"}, {"LocationZip"=>"60612", "LocationCity"=>"Chicago", "LocationState"=>"Illinois", "LocationCountry"=>"United States", "LocationFacility"=>"Rush Presbyterian - Saint Luke's Med Ctr"}, {"LocationZip"=>"46202", "LocationCity"=>"Indianapolis", "LocationState"=>"Indiana", "LocationCountry"=>"United States", "LocationFacility"=>"Division of Inf Diseases/ Indiana Univ Hosp"}, {"LocationZip"=>"21287", "LocationCity"=>"Baltimore", "LocationState"=>"Maryland", "LocationCountry"=>"United States", "LocationFacility"=>"Johns Hopkins Hosp"}, {"LocationZip"=>"452670405", "LocationCity"=>"Cincinnati", "LocationState"=>"Ohio", "LocationCountry"=>"United States", "LocationFacility"=>"Univ of Cincinnati"}, {"LocationZip"=>"44106", "LocationCity"=>"Cleveland", "LocationState"=>"Ohio", "LocationCountry"=>"United States", "LocationFacility"=>"Case Western Reserve Univ"}, {"LocationZip"=>"19104", "LocationCity"=>"Philadelphia", "LocationState"=>"Pennsylvania", "LocationCountry"=>"United States", "LocationFacility"=>"Univ of Pennsylvania at Philadelphia"}, {"LocationZip"=>"981224304", "LocationCity"=>"Seattle", "LocationState"=>"Washington", "LocationCountry"=>"United States", "LocationFacility"=>"Univ of Washington"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"MacArthur R", "OverallOfficialRole"=>"Study Chair"}, {"OverallOfficialName"=>"Benson C", "OverallOfficialRole"=>"Study Chair"}, {"OverallOfficialName"=>"Lederman M", "OverallOfficialRole"=>"Study Chair"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "LeadSponsorClass"=>"NIH"}}}}}}