Nctid:
NCT00000762
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-09-05"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000007239", "term"=>"Infections"}, {"id"=>"D000003141", "term"=>"Communicable Diseases"}, {"id"=>"D000015658", "term"=>"HIV Infections"}, {"id"=>"D000000163", "term"=>"Acquired Immunodeficiency Syndrome"}], "ancestors"=>[{"id"=>"D000020969", "term"=>"Disease Attributes"}, {"id"=>"D000010335", "term"=>"Pathologic Processes"}, {"id"=>"D000086982", "term"=>"Blood-Borne 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"}, {"id"=>"D000012897", "term"=>"Slow Virus Diseases"}], "browseLeaves"=>[{"id"=>"M10283", "name"=>"Infections", "asFound"=>"Infection", "relevance"=>"HIGH"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "asFound"=>"Infection", "relevance"=>"HIGH"}, {"id"=>"M18250", "name"=>"HIV Infections", "asFound"=>"HIV Infections", "relevance"=>"HIGH"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "asFound"=>"HIV Infections", "relevance"=>"HIGH"}, {"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M22700", "name"=>"Disease Attributes", "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"}, {"id"=>"M15700", "name"=>"Slow Virus 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"=>{"browseLeaves"=>[{"id"=>"M17360", "name"=>"Vaccines", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"maskingInfo"=>{"masking"=>"DOUBLE"}, "primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>72}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2021-10", "completionDateStruct"=>{"date"=>"1996-02", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2021-10-27", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2021-11-03", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Vaccines, Synthetic", "HIV Envelope Protein gp160", "HIV Envelope Protein gp120", "AIDS Vaccines", "HIV Therapeutic Vaccine"], "conditions"=>["HIV Infections"]}, "referencesModule"=>{"references"=>[{"type"=>"BACKGROUND", "citation"=>"Lambert JS, McNamara J, Katz S, Fenton T, Nichols J, Roberts NJ. Safety and immunogenicity of recombinant envelope HIV vaccines in asymptomatic HIV-infected children. Natl Conf Hum Retroviruses Relat Infect (1st). 1993 Dec 12-16:72"}, {"type"=>"BACKGROUND", "citation"=>"Lambert JS, et al. Safety and immunogenicity of recombinant envelope HIV vaccines in asymptomatic HIV infected children. Natl Conf Hum Retroviruses Relat Infect (2nd). 1995 Jan 29-Feb 2:151"}, {"pmid"=>"9859958", "type"=>"BACKGROUND", "citation"=>"Lambert JS, McNamara J, Katz SL, Fenton T, Kang M, VanCott TC, Livingston R, Hawkins E, Moye J Jr, Borkowsky W, Johnson D, Yogev R, Duliege AM, Francis D, Gershon A, Wara D, Martin N, Levin M, McSherry G, Smith G. Safety and immunogenicity of HIV recombinant envelope vaccines in HIV-infected infants and children. National Institutes of Health-sponsored Pediatric AIDS Clinical Trials Group (ACTG-218). J Acquir Immune Defic Syndr Hum Retrovirol. 1998 Dec 15;19(5):451-61. doi: 10.1097/00042560-199812150-00003."}, {"type"=>"BACKGROUND", "citation"=>"Lambert JS, McNamara J, Katz S, Livingston R, Moye J. Safety and immunogenicity of HIV recombinant envelope vaccines in HIV-infected infants and children. Pediatric AIDS Clinical Trials Group Study ACTG 218. 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):279 (unnumbered abstract)"}, {"pmid"=>"16220994", "type"=>"RESULT", "citation"=>"Lambert JS. HIV vaccines in infants and children. Paediatr Drugs. 2005;7(5):267-76. doi: 10.2165/00148581-200507050-00001."}]}, "descriptionModule"=>{"briefSummary"=>"To determine the safety and immunogenicity of gp160 (MicroGeneSys), rgp120/HIV-1MN (Genentech), and rgp120/HIV-1SF2 (BIOCINE) and their adjuvants in HIV-infected children 1 month to 18 years of age.\n\nThe initiation of this immunotherapy trial will provide multiple benefits by assessing in asymptomatic HIV-infected children a therapy currently being tested in their adult counterparts, in the hope of forestalling the progression of HIV immunosuppression and clinical disease.", "detailedDescription"=>"The initiation of this immunotherapy trial will provide multiple benefits by assessing in asymptomatic HIV-infected children a therapy currently being tested in their adult counterparts, in the hope of forestalling the progression of HIV immunosuppression and clinical disease.\n\nPatients are randomized to receive one of three vaccines (9 patients/vaccine) or the adjuvant placebos (3 patients/vaccine). The vaccines will be studied at both low and high doses. When three of four patients at the low dose of a vaccine have received two immunizations without evidence of dose-limiting toxicity, dose escalation to the higher dose of that vaccine is initiated in subsequent patient cohorts, provided all low dose arms are filled. A total of six immunizations are given, at 0, 4, 8, 12, 16, and 24 weeks. Patients are followed for 24 weeks after the last immunization."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT"], "maximumAge"=>"18 years", "minimumAge"=>"1 month", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication: Recommended:\n\n* PCP prophylaxis.\n\nPatients must have:\n\n* Documented asymptomatic HIV infection.\n* CD4+ count as follows:\n* 1-11 months of age must have \\> 2000 cells/mm3 and \\>= 30 percent of the total lymphocytes; 12-23 months must have \\> 1000 cells/mm3 and \\>= 20 percent of the total lymphocytes; 24 months-6 years must have \\> 750 cells/mm3 and \\>= 20 percent of the total lymphocytes; and 7 years and older must have \\> 500 cells/mm3 and \\>= 20 percent of the total lymphocytes.\n\nNOTE:\n\n* Patients who received zidovudine for 3 consecutive months immediately prior to study entry may receive only high doses of vaccine.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following condition are excluded:\n\n* Any serious acute infection.\n\nConcurrent Medication:\n\nExcluded:\n\n* Anticipated steroid therapy of \\> 6 weeks duration.\n\nExcluded within the past 2 years:\n\n* More than one serious proven bacterial infection such as sepsis, pneumonia, meningitis, bone or joint infection, abscess of an internal organ or body cavity (other than otitis media or superficial skin or mucosal abscesses) caused by Haemophilus, Streptococcus, Pneumococcus, or other pyogenic bacteria.\n\nPrior Medication:\n\nExcluded:\n\n* Antiretroviral therapy or immunomodulators (e.g., IVIG) within 1 month prior to study entry (NOTE: AZT is allowed within 1 month prior to study entry if patient is entering a high-dose arm).\n* Uninterrupted steroid therapy of \\> 6 weeks duration."}, "identificationModule"=>{"nctId"=>"NCT00000762", "briefTitle"=>"A Placebo-Controlled, Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Envelope Proteins of HIV-1 gp160 and gp120 in Children >= 1 Month Old With Asymptomatic HIV Infection", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "officialTitle"=>"A Placebo-Controlled, Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Envelope Proteins of HIV-1 gp160 and gp120 in Children >= 1 Month Old With Asymptomatic HIV Infection", "orgStudyIdInfo"=>{"id"=>"ACTG 218"}, "secondaryIdInfos"=>[{"id"=>"11195", "type"=>"REGISTRY", "domain"=>"DAIDS ES Registry Number"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"rgp120/HIV-1MN", "type"=>"BIOLOGICAL"}, {"name"=>"rgp120/HIV-1 SF-2", "type"=>"BIOLOGICAL"}, {"name"=>"gp160 Vaccine (MicroGeneSys)", "type"=>"BIOLOGICAL"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"90801", "city"=>"Long Beach", "state"=>"California", "country"=>"United States", "facility"=>"Long Beach Memorial Med. Ctr., Miller Children's Hosp.", "geoPoint"=>{"lat"=>33.76696, "lon"=>-118.18923}}, {"zip"=>"900481804", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"Childrens Hosp. LA - Dept. of Ped., Div. of Clinical Immunology & Allergy", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"900951752", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"946091809", "city"=>"Oakland", "state"=>"California", "country"=>"United States", "facility"=>"Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.", "geoPoint"=>{"lat"=>37.80437, "lon"=>-122.2708}}, {"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 Pediatric AIDS CRS", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"905022004", "city"=>"Torrance", "state"=>"California", "country"=>"United States", "facility"=>"Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases", "geoPoint"=>{"lat"=>33.83585, "lon"=>-118.34063}}, {"zip"=>"06032", "city"=>"Farmington", "state"=>"Connecticut", "country"=>"United States", "facility"=>"Univ. of Connecticut Health Ctr., Dept. of Ped.", "geoPoint"=>{"lat"=>41.71982, "lon"=>-72.83204}}, {"zip"=>"06504", "city"=>"New Haven", "state"=>"Connecticut", "country"=>"United States", "facility"=>"Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease", "geoPoint"=>{"lat"=>41.30815, "lon"=>-72.92816}}, {"zip"=>"60612", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Cook County Hosp.", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"60612", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Univ. of Illinois College of Medicine at Chicago, Dept. of Peds.", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"606143394", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"606371470", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Chicago Children's CRS", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"701122699", "city"=>"New Orleans", "state"=>"Louisiana", "country"=>"United States", "facility"=>"Tulane/LSU Maternal/Child CRS", "geoPoint"=>{"lat"=>29.95465, "lon"=>-90.07507}}, {"city"=>"Baltimore", "state"=>"Maryland", "country"=>"United States", "facility"=>"Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases", "geoPoint"=>{"lat"=>39.29038, "lon"=>-76.61219}}, {"zip"=>"021155724", "city"=>"Boston", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"HMS - Children's Hosp. Boston, Div. of Infectious Diseases", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}, {"zip"=>"02118", "city"=>"Boston", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"BMC, Div. of Ped Infectious Diseases", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}, {"zip"=>"01199", "city"=>"Springfield", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Baystate Health, Baystate Med. Ctr.", "geoPoint"=>{"lat"=>42.10148, "lon"=>-72.58981}}, {"zip"=>"016550001", "city"=>"Worcester", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"WNE Maternal Pediatric Adolescent AIDS CRS", "geoPoint"=>{"lat"=>42.26259, "lon"=>-71.80229}}, {"city"=>"New Brunswick", "state"=>"New Jersey", "country"=>"United States", "facility"=>"UMDNJ - Robert Wood Johnson", "geoPoint"=>{"lat"=>40.48622, "lon"=>-74.45182}}, {"zip"=>"071072198", "city"=>"Newark", "state"=>"New Jersey", "country"=>"United States", "facility"=>"NJ Med. School CRS", "geoPoint"=>{"lat"=>40.73566, "lon"=>-74.17237}}, {"zip"=>"07103", "city"=>"Paterson", "state"=>"New Jersey", "country"=>"United States", "facility"=>"St. Joseph's Hosp. & Med. Ctr. of New Jersey", "geoPoint"=>{"lat"=>40.91677, "lon"=>-74.17181}}, {"zip"=>"11203", "city"=>"Brooklyn", "state"=>"New York", "country"=>"United States", "facility"=>"SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS", "geoPoint"=>{"lat"=>40.6501, "lon"=>-73.94958}}, {"zip"=>"11021", "city"=>"Great Neck", "state"=>"New York", "country"=>"United States", "facility"=>"North Shore-Long Island Jewish Health System, Dept. of Peds.", "geoPoint"=>{"lat"=>40.80066, "lon"=>-73.72846}}, {"zip"=>"10016", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"NYU Med. Ctr., Dept. of Medicine", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"10032", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Columbia IMPAACT CRS", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"10032", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Incarnation Children's Ctr.", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"14642", "city"=>"Rochester", "state"=>"New York", "country"=>"United States", "facility"=>"Univ. of Rochester ACTG CRS", "geoPoint"=>{"lat"=>43.15478, "lon"=>-77.61556}}, {"city"=>"Syracuse", "state"=>"New York", "country"=>"United States", "facility"=>"SUNY Upstate Med. Univ., Dept. of Peds.", "geoPoint"=>{"lat"=>43.04812, "lon"=>-76.14742}}, {"zip"=>"277103499", "city"=>"Durham", "state"=>"North Carolina", "country"=>"United States", "facility"=>"DUMC Ped. CRS", "geoPoint"=>{"lat"=>35.99403, "lon"=>-78.89862}}, {"zip"=>"191044318", "city"=>"Philadelphia", "state"=>"Pennsylvania", "country"=>"United States", "facility"=>"The Children's Hosp. of Philadelphia IMPAACT CRS", "geoPoint"=>{"lat"=>39.95233, "lon"=>-75.16379}}, {"zip"=>"191341095", "city"=>"Philadelphia", "state"=>"Pennsylvania", "country"=>"United States", "facility"=>"St. Christopher's Hosp. for Children", "geoPoint"=>{"lat"=>39.95233, "lon"=>-75.16379}}, {"zip"=>"77030", "city"=>"Houston", "state"=>"Texas", "country"=>"United States", "facility"=>"Texas Children's Hosp. CRS", "geoPoint"=>{"lat"=>29.76328, "lon"=>-95.36327}}, {"zip"=>"009367344", "city"=>"San Juan", "country"=>"Puerto Rico", "facility"=>"San Juan City Hosp. PR NICHD CRS", "geoPoint"=>{"lat"=>18.46633, "lon"=>-66.10572}}], "overallOfficials"=>[{"name"=>"Lambert JS", "role"=>"STUDY_CHAIR"}, {"name"=>"Katz S", "role"=>"STUDY_CHAIR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}, "collaborators"=>[{"name"=>"Genentech, Inc.", "class"=>"INDUSTRY"}, {"name"=>"MicroGeneSys Inc (nka Protein Sciences Corporation)", "class"=>"UNKNOWN"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
