Nctid:
NCT00001000
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-16"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000007239", "term"=>"Infections"}], "browseLeaves"=>[{"id"=>"M10283", "name"=>"Infections", "asFound"=>"Infection", "relevance"=>"HIGH"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "relevance"=>"LOW"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "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"=>"C000047490", "term"=>"poly(I).poly(c12,U)"}], "ancestors"=>[{"id"=>"D000000998", "term"=>"Antiviral Agents"}, {"id"=>"D000000890", "term"=>"Anti-Infective Agents"}], "browseLeaves"=>[{"id"=>"M4314", "name"=>"Antiviral Agents", "relevance"=>"LOW"}, {"id"=>"M255799", "name"=>"poly(I).poly(c12,U)", "asFound"=>"Squamous cell carcinoma of the paranasal sinus", "relevance"=>"HIGH"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"maskingInfo"=>{"masking"=>"DOUBLE"}, "primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>20}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2012-10", "completionDateStruct"=>{"date"=>"1990-01", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2012-10-18", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2012-10-19", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Macrophage Activation", "Lymphocyte Transformation", "Immunologic Surveillance", "ampligen", "Antiviral Agents"], "conditions"=>["HIV Infections"]}, "referencesModule"=>{"references"=>[{"pmid"=>"7681656", "type"=>"BACKGROUND", "citation"=>"Hendrix CW, Margolick JB, Petty BG, Markham RB, Nerhood L, Farzadegan H, Ts'o PO, Lietman PS. Biologic effects after a single dose of poly(I):poly(C12U) in healthy volunteers. Antimicrob Agents Chemother. 1993 Mar;37(3):429-35. doi: 10.1128/AAC.37.3.429."}]}, "descriptionModule"=>{"briefSummary"=>"To evaluate the degree and sequence of immunologic enhancement and the cellular resistance to certain infections after a single dose of atvogen (ampligen). In addition, the relationship between activation of immune cells and biochemical markers of that activation will be studied.\n\nTreatment of patients with HIV infection must address both the primary viral infection and the subsequent immune deficiency, which is the primary cause of mortality in AIDS. In vitro studies of ampligen have shown it will inhibit HIV infection. Ampligen may also minimize the toxicity of many drugs used in the treatment of AIDS and induce an antiviral state in the brain that may be useful in treating neurologic symptoms of HIV infection. The time course and degree of immunologic response to ampligen remain unknown although they are essential for proper use of the drug in the treatment of HIV infection and perhaps other clinical problems.", "detailedDescription"=>"Treatment of patients with HIV infection must address both the primary viral infection and the subsequent immune deficiency, which is the primary cause of mortality in AIDS. In vitro studies of ampligen have shown it will inhibit HIV infection. Ampligen may also minimize the toxicity of many drugs used in the treatment of AIDS and induce an antiviral state in the brain that may be useful in treating neurologic symptoms of HIV infection. The time course and degree of immunologic response to ampligen remain unknown although they are essential for proper use of the drug in the treatment of HIV infection and perhaps other clinical problems.\n\nTen healthy volunteers and 10 HIV-infected patients are randomized between ampligen or placebo group. Five volunteers in each group receive a single dose of ampligen on day 1 and a single dose of placebo on day 8. The other 5 volunteers receive the drug and placebo on day 8 and 1, respectively. Seven days of observation and testing follow each administration of drug or placebo and also allow the body to eliminate the drug."}, "eligibilityModule"=>{"sex"=>"MALE", "stdAges"=>["ADULT"], "maximumAge"=>"45 years", "minimumAge"=>"18 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria\n\nPatients' general good health should be determined by screening history, physical examination, and laboratory tests including CBC with differential, erythrocyte sedimentation rate, urinalysis, SMA-24, and drug screen within the established limits of normal for the hospital laboratory.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nThe following subjects will be excluded from the study:\n\n* Smokers.\n* Volunteers who have ingested alcohol 48 hours prior to the study.\n* Volunteers with clinically apparent viral disease or other illnesses, including allergies, within 2 weeks prior to the study or conditions which predispose them to chronic immune stimulation.\n\nConcurrent Medication:\n\nExcluded:\n\n* All medications.\n\nThe following subjects will be excluded from the study:\n\n* Smokers.\n* Volunteers who have ingested alcohol 48 hours prior to the study.\n* Volunteers with clinically apparent viral disease or other illnesses, including allergies, within 2 weeks prior to the study or conditions which predispose them to chronic immune stimulation.\n\nPrior Medication:\n\nExcluded within 2 weeks of study entry:\n\n* All medications.\n\nRecent history of drug or alcohol abuse."}, "identificationModule"=>{"nctId"=>"NCT00001000", "briefTitle"=>"A Study of Atvogen in Healthy Volunteers and HIV-Infected Patients Who Have No Symptoms of Infection", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "officialTitle"=>"Immunologic Effect After Single Dose Atvogen in Healthy Volunteers and Asymptomatic HIV-Infected Patients", "orgStudyIdInfo"=>{"id"=>"ACTG 056"}, "secondaryIdInfos"=>[{"id"=>"11030", "type"=>"REGISTRY", "domain"=>"DAIDS-ES"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Ampligen", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"21287", "city"=>"Baltimore", "state"=>"Maryland", "country"=>"United States", "facility"=>"Johns Hopkins Hosp", "geoPoint"=>{"lat"=>39.29038, "lon"=>-76.61219}}], "overallOfficials"=>[{"name"=>"PS Lietman", "role"=>"STUDY_CHAIR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}}}}
