Nctid:
NCT00000843
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-17"}, "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"=>"C000053001", "term"=>"Adefovir"}, {"id"=>"C000106812", "term"=>"Adefovir dipivoxil"}], "ancestors"=>[{"id"=>"D000000998", "term"=>"Antiviral Agents"}, {"id"=>"D000000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D000018894", "term"=>"Reverse Transcriptase Inhibitors"}, {"id"=>"D000019384", "term"=>"Nucleic Acid Synthesis Inhibitors"}, {"id"=>"D000004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}], "browseLeaves"=>[{"id"=>"M4314", "name"=>"Antiviral Agents", "relevance"=>"LOW"}, {"id"=>"M219518", "name"=>"Adefovir", "asFound"=>"Changing", "relevance"=>"HIGH"}, {"id"=>"M341402", "name"=>"Adefovir dipivoxil", "asFound"=>"Square meter", "relevance"=>"HIGH"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M20935", "name"=>"Reverse Transcriptase Inhibitors", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "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"=>24}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1998-04", "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"=>["Antiviral Agents", "Adenine"], "conditions"=>["HIV Infections"]}, "referencesModule"=>{"references"=>[{"type"=>"BACKGROUND", "citation"=>"McKinney RE Jr. Ongoing and future trials of antiretroviral therapy in the pediatric AIDS clinical trials group (PACTG). Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:173"}]}, "descriptionModule"=>{"briefSummary"=>"To evaluate the single-dose pharmacokinetic profile and acute toxicity of bis-POM PMEA ( adefovir dipivoxil ) in HIV-1 infected children, and to determine whether age-related differences exist. To ascertain dosages that may be suitable for a multiple-dose evaluation in this patient population.\n\nAlthough the oral bioavailability of PMEA ( adefovir ) is low, the prodrug bis-POM PMEA has resulted in increased bioavailability in adult patients in clinical trials. However, the safety and pharmacokinetic patterns of drugs in infants often differ from those of adults and the direction of the variation is not predictable. This study will assess these parameters of bis-POM PMEA in children.", "detailedDescription"=>"Although the oral bioavailability of PMEA ( adefovir ) is low, the prodrug bis-POM PMEA has resulted in increased bioavailability in adult patients in clinical trials. However, the safety and pharmacokinetic patterns of drugs in infants often differ from those of adults and the direction of the variation is not predictable. This study will assess these parameters of bis-POM PMEA in children.\n\nPatients are stratified by age, and separate cohorts from each age group receive 1 of 2 single doses of bis-POM PMEA. The lower dose is given to patients ages 3 months through 17 years; if toxicity is acceptable, the other cohort in this age range receives the higher dose. At this point, accrual of infants \\< 3 months old may begin at the lower dose, followed by accrual of this age group at the higher dose if toxicity is acceptable. Serum drug concentrations are monitored up to 8 hours post dose.\n\nAS PER AMENDMENT 5/2/97: Based on data from both the low- and high-dose cohorts of the older age group (\\>= 3 months to \\< 18 years), the younger age group (\\<3 months) will be started at the high-dose."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD"], "maximumAge"=>"17 years", "minimumAge"=>"1 day", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nPatients must have:\n\n* Asymptomatic or mildly symptomatic HIV infection, with no worse than grade 1 toxicity for any symptoms.\n* Consent of parent or guardian.\n\nPrior Medication:\n\nAllowed:\n\n* IV gammaglobulin and aerosolized pentamidine for PCP prophylaxis.\n* Antiretrovirals if discontinued by 72 hr prior to study entry.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\n* Acute or chronic infections that require treatment during study.\n\nConcurrent Medication:\n\nExcluded:\n\n* Antiretrovirals other than study drug.\n* Other investigational agents.\n* Immunomodulators.\n* HIV-1 vaccines.\n* Glucocorticoids.\n* Drugs with potential for adverse interaction with study drug or that would interfere with quantitation of study drug in serum or plasma.\n* TMP / SMX and dapsone.\n\nPER AMENDMENT 8/23/96:\n\n* Drugs which may affect renal excretion:\n* Probenecid, Acyclovir, Ganciclovir, Foscarnet, Amphotericin B and Pentamidine.\n\nPrior Medication:\n\nExcluded within 72 hr prior to study entry:\n\n* Antiretrovirals other than study drug.\n* Other investigational agents.\n* Immunomodulators.\n* HIV-1 vaccines.\n* Glucocorticoids.\n* Drugs with potential for adverse interaction with study drug or that would interfere with quantitation of study drug in serum or plasma.\n* TMP / SMX and dapsone.\n\nPER AMENDMENT 8/23/96:\n\n* Drugs which may affect renal excretion:\n* Probenecid, Acyclovir, Ganciclovir, Foscarnet, Amphotericin B and Pentamidine."}, "identificationModule"=>{"nctId"=>"NCT00000843", "briefTitle"=>"The Safety and Effectiveness of Adefovir Dipivoxil in HIV-Infected Children", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "officialTitle"=>"A Phase IA Single Dose Pharmacokinetics and Safety Study of the Oral Antiviral Compound, 9-[2-(Bispivaloyloxymethyl)Phosphonylmethoxyethyl]Adenine (Bis-POM PMEA) (Adefovir Dipivoxil) in Children With HIV-1 Infection", "orgStudyIdInfo"=>{"id"=>"ACTG 310"}}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Adefovir dipivoxil", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"941430105", "city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"UCSF / Moffitt Hosp - Pediatric", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"32209", "city"=>"Jacksonville", "state"=>"Florida", "country"=>"United States", "facility"=>"Univ of Florida Health Science Ctr / Pediatrics", "geoPoint"=>{"lat"=>30.33218, "lon"=>-81.65565}}, {"zip"=>"606143394", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Chicago Children's Memorial Hosp", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"212874933", "city"=>"Baltimore", "state"=>"Maryland", "country"=>"United States", "facility"=>"Johns Hopkins Hosp - Pediatric", "geoPoint"=>{"lat"=>39.29038, "lon"=>-76.61219}}, {"zip"=>"021155724", "city"=>"Boston", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Children's Hosp of Boston", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}, {"zip"=>"071072198", "city"=>"Newark", "state"=>"New Jersey", "country"=>"United States", "facility"=>"Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl", "geoPoint"=>{"lat"=>40.73566, "lon"=>-74.17237}}, {"zip"=>"191044318", "city"=>"Philadelphia", "state"=>"Pennsylvania", "country"=>"United States", "facility"=>"Children's Hosp of Philadelphia", "geoPoint"=>{"lat"=>39.95233, "lon"=>-75.16379}}, {"zip"=>"381052794", "city"=>"Memphis", "state"=>"Tennessee", "country"=>"United States", "facility"=>"Saint Jude Children's Research Hosp of Memphis", "geoPoint"=>{"lat"=>35.14953, "lon"=>-90.04898}}, {"zip"=>"372322581", "city"=>"Nashville", "state"=>"Tennessee", "country"=>"United States", "facility"=>"Vanderbilt Univ Med Ctr", "geoPoint"=>{"lat"=>36.16589, "lon"=>-86.78444}}, {"zip"=>"009365067", "city"=>"San Juan", "country"=>"Puerto Rico", "facility"=>"Univ of Puerto Rico / Univ Children's Hosp AIDS", "geoPoint"=>{"lat"=>18.46633, "lon"=>-66.10572}}], "overallOfficials"=>[{"name"=>"Hughes W", "role"=>"STUDY_CHAIR"}, {"name"=>"Shenep J", "role"=>"STUDY_CHAIR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}}}}
