Double Blind Study of Thymopentin Effects on Patients With HIV-1 Infection

Launched by IMMUNOBIOLOGY RESEARCH INSTITUTE · Aug 30, 2001

Nctid: NCT00002066

Payload: {"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-27"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D007239", "term"=>"Infections"}, {"id"=>"D003141", "term"=>"Communicable Diseases"}], "ancestors"=>[{"id"=>"D020969", "term"=>"Disease Attributes"}, {"id"=>"D010335", "term"=>"Pathologic Processes"}], "browseLeaves"=>[{"id"=>"M10283", "name"=>"Infections", "asFound"=>"Infection", "relevance"=>"HIGH"}, {"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "asFound"=>"Infection", "relevance"=>"HIGH"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M22700", "name"=>"Disease Attributes", "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"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D016305", "term"=>"Thymopentin"}], "ancestors"=>[{"id"=>"D000276", "term"=>"Adjuvants, Immunologic"}, {"id"=>"D007155", "term"=>"Immunologic Factors"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}], "browseLeaves"=>[{"id"=>"M18751", "name"=>"Thymopentin", "asFound"=>"Peroneus longus", "relevance"=>"HIGH"}, {"id"=>"M3628", "name"=>"Adjuvants, Immunologic", "relevance"=>"LOW"}, {"id"=>"M10201", "name"=>"Immunologic Factors", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"maskingInfo"=>{"masking"=>"DOUBLE"}, "primaryPurpose"=>"TREATMENT"}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1989-11", "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"=>["Thymopentin", "Acquired Immunodeficiency Syndrome"], "conditions"=>["HIV Infections"]}, "descriptionModule"=>{"briefSummary"=>"Examine the ability of thymopentin (Timunox) to:\n\nReduce the amount and/or frequency of virus isolation. Stimulate the immune system and alter the clinical findings in patients infected with HIV who do not yet have AIDS."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Aerosolized pentamidine.\n\nPrior Medication:\n\nAllowed:\n\n* Aerosolized pentamidine.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with an abnormal chest x-ray indicative of active disease (opportunistic infection) within 30 days prior to entry are excluded.\n\nConcurrent Medication:\n\nExcluded within 90 days of study entry:\n\n* Zidovudine (AZT).\n\nPrior Medication:\n\nExcluded within 30 days of study entry:\n\n* Immunomodulatory or experimental therapy.\n* Excluded within 90 days of study entry:\n* Zidovudine (AZT).\n\nPatients must not have:\n\n* Hemophilia A or B or other hematologic disorders requiring current or previous administration of blood products.\n* AIDS as defined by the CDC (except for those with HIV \"wasting syndrome\").\n* Significant hepatic disease.\n* Thrombocytopenia (\\< 75000 platelets/mm3).\n\nPatient must voluntarily sign consent and be seropositive for HIV-1 (ELISA assay) confirmed by Western blot.\n\n* HIV-1 p24 antigen must be detected in supernatant fluids from co-cultures of patient's peripheral blood monocytes (PBMC) on two separate occasions.\n* Patients with HIV \"wasting syndrome\" are included.\n\nIntravenous drug abuse."}, "identificationModule"=>{"nctId"=>"NCT00002066", "briefTitle"=>"Double Blind Study of Thymopentin Effects on Patients With HIV-1 Infection", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"NIH AIDS Clinical Trials Information Service"}, "officialTitle"=>"Double Blind Study of Thymopentin Effects on Patients With HIV-1 Infection", "orgStudyIdInfo"=>{"id"=>"015A"}, "secondaryIdInfos"=>[{"id"=>"07 32 005"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Thymopentin", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"088010999", "city"=>"Annandale", "state"=>"New Jersey", "country"=>"United States", "facility"=>"Immunobiology Research Institute", "geoPoint"=>{"lat"=>40.64093, "lon"=>-74.88128}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Immunobiology Research Institute", "class"=>"INDUSTRY"}}}}