Nctid:
NCT00000808
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D015658", "term"=>"HIV Infections"}], "ancestors"=>[{"id"=>"D000086982", "term"=>"Blood-Borne Infections"}, {"id"=>"D003141", "term"=>"Communicable Diseases"}, {"id"=>"D007239", "term"=>"Infections"}, {"id"=>"D015229", "term"=>"Sexually Transmitted Diseases, Viral"}, {"id"=>"D012749", "term"=>"Sexually Transmitted Diseases"}, {"id"=>"D016180", "term"=>"Lentivirus Infections"}, {"id"=>"D012192", "term"=>"Retroviridae Infections"}, {"id"=>"D012327", "term"=>"RNA Virus Infections"}, {"id"=>"D014777", "term"=>"Virus Diseases"}, {"id"=>"D000091662", "term"=>"Genital Diseases"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}, {"id"=>"D007153", "term"=>"Immunologic Deficiency Syndromes"}, {"id"=>"D007154", "term"=>"Immune System Diseases"}], "browseLeaves"=>[{"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "asFound"=>"HIV Infections", "relevance"=>"HIGH"}, {"id"=>"M14127", "name"=>"Pregnancy Complications", "relevance"=>"LOW"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M14130", "name"=>"Pregnancy Complications, Infectious", "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"=>"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"=>"D019829", "term"=>"Nevirapine"}], "ancestors"=>[{"id"=>"D018894", "term"=>"Reverse Transcriptase Inhibitors"}, {"id"=>"D019384", "term"=>"Nucleic Acid Synthesis Inhibitors"}, {"id"=>"D004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000998", "term"=>"Antiviral Agents"}, {"id"=>"D000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D019380", "term"=>"Anti-HIV Agents"}, {"id"=>"D044966", "term"=>"Anti-Retroviral Agents"}, {"id"=>"D065701", "term"=>"Cytochrome P-450 CYP3A Inducers"}, {"id"=>"D065693", "term"=>"Cytochrome P-450 Enzyme Inducers"}], "browseLeaves"=>[{"id"=>"M21717", "name"=>"Nevirapine", "asFound"=>"Restricted", "relevance"=>"HIGH"}, {"id"=>"M20935", "name"=>"Reverse Transcriptase Inhibitors", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M4314", "name"=>"Antiviral Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M21350", "name"=>"Anti-HIV Agents", "relevance"=>"LOW"}, {"id"=>"M25428", "name"=>"Anti-Retroviral Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>49}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2021-10", "completionDateStruct"=>{"date"=>"1998-09", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2021-10-27", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2021-11-04", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Pregnancy", "Pregnancy Complications, Infectious", "Acquired Immunodeficiency Syndrome", "AIDS-Related Complex", "Nevirapine"], "conditions"=>["HIV Infections", "Pregnancy"]}, "referencesModule"=>{"references"=>[{"pmid"=>"11364450", "type"=>"BACKGROUND", "citation"=>"Vazquez E. Two bucks a baby. Posit Aware. 1997 Mar-Apr;8(2):15."}, {"pmid"=>"11362587", "type"=>"BACKGROUND", "citation"=>"Benson M, Shannon M. Nevirapine: ethical dilemmas and care for HIV-infected mothers. Focus. 1995 Jun;10(7):5-6."}, {"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"}, {"type"=>"BACKGROUND", "citation"=>"Mirochnick M, Sullivan J, Cort S, Mcnamara J, Fenton T, Sperling R. Safety and pharmacokinetics (pk) of nevirapine (NVP) in HIV-I infected pregnant women and their newborns. ACTG Protocol 250 Team. American Pediatric Association and Society for Pediatric Research annual meeting; 1996 May 6-10; Washington, D.C. Pediatr AIDS HIV Infect. 1996 Aug;7(4):280 (unnumbered abstract)"}, {"pmid"=>"9697716", "type"=>"BACKGROUND", "citation"=>"Mirochnick M, Fenton T, Gagnier P, Pav J, Gwynne M, Siminski S, Sperling RS, Beckerman K, Jimenez E, Yogev R, Spector SA, Sullivan JL. Pharmacokinetics of nevirapine in human immunodeficiency virus type 1-infected pregnant women and their neonates. Pediatric AIDS Clinical Trials Group Protocol 250 Team. J Infect Dis. 1998 Aug;178(2):368-74. doi: 10.1086/515641."}]}, "descriptionModule"=>{"briefSummary"=>"To determine the bioavailability, pharmacokinetics, and short-term safety and tolerance of nevirapine in HIV-1 infected pregnant women and their newborns when nevirapine is given to the mother during active labor, and when their neonates are dosed during the first week of life. To determine the short-term safety profile of mothers receiving zidovudine (AZT) who received nevirapine during active labor, and their neonates who received no dose, a single dose, or multiple doses of nevirapine and who are receiving AZT during the first 6 weeks of life.\n\nTreatment of HIV-1 infected pregnant women during active labor may result in therapeutic levels of nevirapine in the neonate at the time of exposure to HIV-1 during parturition, decreasing the neonate's risk of infection.", "detailedDescription"=>"Treatment of HIV-1 infected pregnant women during active labor may result in therapeutic levels of nevirapine in the neonate at the time of exposure to HIV-1 during parturition, decreasing the neonate's risk of infection.\n\nPregnant women in active labor receive single doses of oral nevirapine. The neonates of the first 4-6 (PER AMENDMENT 8/27/96, was 4) mothers receive no drug, while the neonates of the second 4-6 (PER AMENDMENT 8/27/96, was 4) patient cohort receive a single dose of nevirapine. If neonatal antiviral levels of nevirapine are not sustained for 7 days after the single dose, a third cohort of 4-6 (PER AMENDMENT 8/27/96, was 4) pregnant women will receive a single dose of nevirapine and their neonates will receive multiple doses of nevirapine to maintain an antiviral effect for 7 days."}, "eligibilityModule"=>{"sex"=>"FEMALE", "stdAges"=>["CHILD", "ADULT"], "maximumAge"=>"60 years", "minimumAge"=>"13 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* AZT (mothers and neonates).\n* Oral asthma inhalers (mothers).\n\nConcurrent Treatment:\n\nAllowed:\n\n* Phototherapy (neonates).\n\nMOTHERS must have:\n\n* HIV infection.\n* Estimated gestational age \\>= 34 weeks.\n* No active opportunistic infection at study entry.\n\nPER AMENDMENT 8/27/96:\n\n* A pre-enrollment plasma HIV-1 RNA level greater than 10,000 copies/ml.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nMOTHERS with the following symptoms or conditions are excluded:\n\n* Intrauterine growth retardation.\n* Fetal anomaly incompatible with life as determined by pre-entry ultrasound.\n* Participation during current pregnancy in any other therapeutic or vaccine perinatal trial.\n* Known hypersensitivity to any benzodiazepine.\n* Serious bacterial infection.\n\nConcurrent Medication:\n\nExcluded:\n\n* Any antiretroviral other than AZT.\n* Corticosteroids (other than oral asthma inhalers).\n* Anticoagulants.\n* Any clavulanic acid-containing formulation (e.g., Augmentin, Timentin).\n* Benzodiazepines other than study drug.\n* Phenobarbital.\n* Barbiturates.\n* Antacids.\n* Magnesium sulfate.\n\nPrior Medication:\n\nExcluded:\n\n* Prior nevirapine.\n\nCurrent use of illicit substances and/or active chronic alcohol use."}, "identificationModule"=>{"nctId"=>"NCT00000808", "briefTitle"=>"A Phase I Study of Safety and Pharmacokinetics of Nevirapine in HIV-1 Infected Pregnant Women and Neonates Born to HIV-1 Infected Mothers", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "officialTitle"=>"A Phase I Study of Safety and Pharmacokinetics of Nevirapine in HIV-1 Infected Pregnant Women and Neonates Born to HIV-1 Infected Mothers", "orgStudyIdInfo"=>{"id"=>"ACTG 250"}, "secondaryIdInfos"=>[{"id"=>"11227", "type"=>"REGISTRY", "domain"=>"DAIDS ES Registry Number"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Nevirapine", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"920930672", "city"=>"La Jolla", "state"=>"California", "country"=>"United States", "facility"=>"UCSD Med Ctr / Pediatrics / Clinical Sciences", "geoPoint"=>{"lat"=>32.84727, "lon"=>-117.2742}}, {"zip"=>"90033", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"Los Angeles County - USC Med Ctr", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"900951752", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"UCLA Med Ctr / Pediatric", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"905022004", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"Harbor - UCLA Med Ctr / UCLA School of Medicine", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"94110", "city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"San Francisco Gen Hosp", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"941430105", "city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"UCSF / Moffitt Hosp - Pediatric", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"06032", "city"=>"Farmington", "state"=>"Connecticut", "country"=>"United States", "facility"=>"Univ of Connecticut / Farmington", "geoPoint"=>{"lat"=>41.71982, "lon"=>-72.83204}}, {"zip"=>"06106", "city"=>"Hartford", "state"=>"Connecticut", "country"=>"United States", "facility"=>"Connecticut Children's Med Ctr - Pediatric", "geoPoint"=>{"lat"=>41.76371, "lon"=>-72.68509}}, {"zip"=>"606143394", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Chicago Children's Memorial Hosp", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"606371470", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Univ of Chicago Children's Hosp", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"021155724", "city"=>"Boston", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Children's Hosp of Boston", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}, {"zip"=>"02118", "city"=>"Boston", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Boston City Hosp / Pediatrics", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}, {"zip"=>"016550001", "city"=>"Worcester", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Univ of Massachusetts Med School", "geoPoint"=>{"lat"=>42.26259, "lon"=>-71.80229}}, {"zip"=>"071032714", "city"=>"Newark", "state"=>"New Jersey", "country"=>"United States", "facility"=>"Univ of Medicine & Dentistry of New Jersey / Univ Hosp", "geoPoint"=>{"lat"=>40.73566, "lon"=>-74.17237}}, {"zip"=>"10029", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Mount Sinai Med Ctr / Pediatrics", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"009367344", "city"=>"San Juan", "country"=>"Puerto Rico", "facility"=>"San Juan City Hosp", "geoPoint"=>{"lat"=>18.46633, "lon"=>-66.10572}}], "overallOfficials"=>[{"name"=>"Sullivan JL", "role"=>"STUDY_CHAIR"}, {"name"=>"Sperling R", "role"=>"STUDY_CHAIR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
