Nctid:
NCT00001015
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-09-05"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000015658", "term"=>"HIV Infections"}], "ancestors"=>[{"id"=>"D000086982", "term"=>"Blood-Borne Infections"}, {"id"=>"D000003141", "term"=>"Communicable Diseases"}, {"id"=>"D000007239", "term"=>"Infections"}, {"id"=>"D000015229", "term"=>"Sexually Transmitted Diseases, Viral"}, {"id"=>"D000012749", "term"=>"Sexually Transmitted Diseases"}, {"id"=>"D000016180", "term"=>"Lentivirus Infections"}, {"id"=>"D000012192", "term"=>"Retroviridae Infections"}, {"id"=>"D000012327", "term"=>"RNA Virus Infections"}, {"id"=>"D000014777", "term"=>"Virus Diseases"}, {"id"=>"D000091662", "term"=>"Genital Diseases"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}, {"id"=>"D000007153", "term"=>"Immunologic Deficiency Syndromes"}, {"id"=>"D000007154", "term"=>"Immune System Diseases"}], "browseLeaves"=>[{"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "asFound"=>"HIV Infections", "relevance"=>"HIGH"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M3735", "name"=>"AIDS-Related Complex", "relevance"=>"LOW"}, {"id"=>"M2593", "name"=>"Blood-Borne Infections", "relevance"=>"LOW"}, {"id"=>"M15558", "name"=>"Sexually Transmitted Diseases", "relevance"=>"LOW"}, {"id"=>"M17933", "name"=>"Sexually Transmitted Diseases, Viral", "relevance"=>"LOW"}, {"id"=>"M18640", "name"=>"Lentivirus Infections", "relevance"=>"LOW"}, {"id"=>"M15026", "name"=>"Retroviridae Infections", "relevance"=>"LOW"}, {"id"=>"M17522", "name"=>"Virus Diseases", "relevance"=>"LOW"}, {"id"=>"M15149", "name"=>"RNA Virus Infections", "relevance"=>"LOW"}, {"id"=>"M2876", "name"=>"Genital Diseases", "relevance"=>"LOW"}, {"id"=>"M2875", "name"=>"Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M10200", "name"=>"Immune System Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000012254", "term"=>"Ribavirin"}], "ancestors"=>[{"id"=>"D000000963", "term"=>"Antimetabolites"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000000998", "term"=>"Antiviral Agents"}, {"id"=>"D000000890", "term"=>"Anti-Infective Agents"}], "browseLeaves"=>[{"id"=>"M15083", "name"=>"Ribavirin", "asFound"=>"Adjuvant", "relevance"=>"HIGH"}, {"id"=>"M4281", "name"=>"Antimetabolites", "relevance"=>"LOW"}, {"id"=>"M4314", "name"=>"Antiviral Agents", "relevance"=>"LOW"}, {"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"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>96}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2021-10", "completionDateStruct"=>{"date"=>"1990-06", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2021-10-28", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2021-11-01", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Ribavirin", "T-Lymphocytes", "Acquired Immunodeficiency Syndrome", "AIDS-Related Complex"], "conditions"=>["HIV Infections"]}, "referencesModule"=>{"references"=>[{"type"=>"BACKGROUND", "citation"=>"Crumpacker C, Pearlstein G, van der Horst C, Valentine F, Spector S, Mills J. A phase one increasing dose trial of oral ribavirin (RBV) in patients with AIDS and ARC. Int Conf AIDS. 1990 Jun 20-23;6(3):203 (abstract no SB468)"}, {"type"=>"BACKGROUND", "citation"=>"Crumpacker C, Cotton D, Pearlstein G, Valentine F, Mills J, Spector S. Ribavirin dose escalating phase 1 trial in patients with AIDS and ARC. Int Conf AIDS. 1989 Jun 4-9;5:336 (abstract no TBP296)"}]}, "descriptionModule"=>{"briefSummary"=>"To determine the maximum long-term dosage of ribavirin (RBV) that is safe and free of serious side effects in patients with AIDS or AIDS related illnesses. Also, to determine what effect different dosage levels have on biologic markers of efficacy, such as the amount of the AIDS virus (HIV) or number of T cells in the patient's blood.\n\nRBV is a new drug capable of inhibiting the growth of the AIDS virus in the laboratory with little effect on normal human cells. In earlier tests of RBV in AIDS patients, the drug was well tolerated and safe, and this favorable result suggested that RBV should be more extensively studied in patients with AIDS and advanced AIDS related complex (ARC).", "detailedDescription"=>"RBV is a new drug capable of inhibiting the growth of the AIDS virus in the laboratory with little effect on normal human cells. In earlier tests of RBV in AIDS patients, the drug was well tolerated and safe, and this favorable result suggested that RBV should be more extensively studied in patients with AIDS and advanced AIDS related complex (ARC).\n\nPatients are selected from three patient groups:\n\n* Patients with AIDS, who have not taken zidovudine (AZT) within 30 days of entry into the study and who have not been discontinued from AZT because of intolerance.\n* Patients with AIDS related diseases who have not taken AZT within 30 days of entry into the study, and who have not been discontinued from AZT because of intolerance.\n* Patients with AIDS or AIDS related diseases who have had AZT intolerance that required cessation of therapy. This is an outpatient study; patients are seen weekly for the first 4 weeks, every other week through week 12, and then every 4 weeks for the duration of the 24 weeks of the treatment portion of the study. Patients from each of the three diagnostic groups are enrolled at each dose level. For the first 3 days after entry into the study, all patients receive the lowest dose of RBV every 6 hours. Subsequent dosages increase until the maximum tolerated dose (MTD) is reached. The MTD for a group is defined as the dose at which 4 or more of the 8 patients in the group develop toxicity which requires a change or discontinuation of the dosage.\n\nPatients who experience significant toxicity may continue in the study at lower dose to determine the long-term tolerance."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Short-course therapy (7 days) with oral acyclovir.\n* Short-course therapy (7 days) with ketoconazole.\n* Topical medications.\n* Aerosolized pentamidine for prophylactic purposes.\n\nConcurrent Treatment:\n\nAllowed:\n\n* Blood transfusions for hemoglobin toxicity.\n\nPatients must have two positive HIV p24 antigen tests with titers = or \\> 70 picograms at least 72 hours apart and within 1 month prior to entry, the last of which must be within 2 weeks of starting therapy.\n\nPrior Medication:\n\nAllowed:\n\n* Zidovudine (AZT), without cessation of therapy required due to intolerance.\n* AZT therapy must be discontinued at least 30 days prior to study entry.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following are excluded:\n\n* Active opportunistic infection, symptomatic visceral Kaposi's sarcoma (KS) or progression of KS within the month prior to entry into the study, neoplasms other than KS, basal cell carcinoma of the skin, or in situ carcinoma of the cervix. Significant diarrhea, defined as = or \\> 3 liquid stools per day within the past week.\n\nConcurrent Medication:\n\nExcluded:\n\n* Ongoing systemic therapy and/or prophylaxis for an AIDS-defining opportunistic infection.\n* Antineoplastic therapy.\n* Other experimental medications.\n* Systemic chemoprophylaxis for Pneumocystis carinii pneumonia.\n* Chronic (\\> 7 days) oral acyclovir therapy.\n\nConcurrent Treatment:\n\nExcluded:\n\n* Blood transfusions unless they are for = or \\> grade 3 hemoglobin toxicity.\n\nPatients with the following are excluded:\n\n* Active opportunistic infection, symptomatic visceral Kaposi's sarcoma (KS) or progression of KS within the month prior to entry into the study, neoplasms other than KS, basal cell carcinoma of the skin, or in situ carcinoma of the cervix. Significant diarrhea, defined as = or \\> 3 liquid stools per day within the past week.\n\nPrior Medication:\n\nExcluded within 30 days of study entry:\n\n* Antiretroviral agents including zidovudine (AZT).\n* Biologic modifiers.\n* Systemic corticosteroids.\n\nPrior Treatment:\n\nExcluded within 2 months of study entry:\n\n* Blood transfusion except for those who have taken zidovudine (AZT) who may not have received a transfusion within the previous month.\n\nActive drug or alcohol abuse."}, "identificationModule"=>{"nctId"=>"NCT00001015", "briefTitle"=>"A Study of Ribavirin in the Treatment of Patients With AIDS and AIDS-Related Problems", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "officialTitle"=>"A Multicenter Phase I Clinical Trial of Ribavirin in the Treatment of Patients With AIDS and Advanced AIDS Related Illnesses", "orgStudyIdInfo"=>{"id"=>"ACTG 034"}, "secondaryIdInfos"=>[{"id"=>"11010", "type"=>"REGISTRY", "domain"=>"DAIDS ES Registry Number"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Ribavirin", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"921036325", "city"=>"San Diego", "state"=>"California", "country"=>"United States", "facility"=>"Univ of California / San Diego Treatment Ctr", "geoPoint"=>{"lat"=>32.71533, "lon"=>-117.15726}}, {"zip"=>"941102859", "city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"San Francisco AIDS Clinic / San Francisco Gen Hosp", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"02114", "city"=>"Boston", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Harvard (Massachusetts Gen Hosp)", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}, {"zip"=>"10016", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Bellevue Hosp / New York Univ Med Ctr", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"275997215", "city"=>"Chapel Hill", "state"=>"North Carolina", "country"=>"United States", "facility"=>"Univ of North Carolina", "geoPoint"=>{"lat"=>35.9132, "lon"=>-79.05584}}], "overallOfficials"=>[{"name"=>"Crumpacker C", "role"=>"STUDY_CHAIR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
