Nctid:
NCT00000822
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-04"}, "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"=>"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"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "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"=>"D019438", "term"=>"Ritonavir"}, {"id"=>"D018119", "term"=>"Stavudine"}, {"id"=>"D016049", "term"=>"Didanosine"}], "ancestors"=>[{"id"=>"D017320", "term"=>"HIV Protease Inhibitors"}, {"id"=>"D000084762", "term"=>"Viral Protease Inhibitors"}, {"id"=>"D011480", "term"=>"Protease Inhibitors"}, {"id"=>"D004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D019380", "term"=>"Anti-HIV Agents"}, {"id"=>"D044966", "term"=>"Anti-Retroviral Agents"}, {"id"=>"D000998", "term"=>"Antiviral Agents"}, {"id"=>"D000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D065692", "term"=>"Cytochrome P-450 CYP3A Inhibitors"}, {"id"=>"D065607", "term"=>"Cytochrome P-450 Enzyme Inhibitors"}, {"id"=>"D000963", "term"=>"Antimetabolites"}, {"id"=>"D018894", "term"=>"Reverse Transcriptase Inhibitors"}, {"id"=>"D019384", "term"=>"Nucleic Acid Synthesis Inhibitors"}], "browseLeaves"=>[{"id"=>"M21394", "name"=>"Ritonavir", "asFound"=>"Associated", "relevance"=>"HIGH"}, {"id"=>"M17360", "name"=>"Vaccines", "relevance"=>"LOW"}, {"id"=>"M20935", "name"=>"Reverse Transcriptase Inhibitors", "relevance"=>"LOW"}, {"id"=>"M19609", "name"=>"HIV Protease Inhibitors", "relevance"=>"LOW"}, {"id"=>"M14343", "name"=>"Protease Inhibitors", "relevance"=>"LOW"}, {"id"=>"M20272", "name"=>"Stavudine", "asFound"=>"Native", "relevance"=>"HIGH"}, {"id"=>"M18548", "name"=>"Didanosine", "asFound"=>"Obinutuzumab", "relevance"=>"HIGH"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M21350", "name"=>"Anti-HIV Agents", "relevance"=>"LOW"}, {"id"=>"M25428", "name"=>"Anti-Retroviral Agents", "relevance"=>"LOW"}, {"id"=>"M4314", "name"=>"Antiviral Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M30564", "name"=>"Cytochrome P-450 CYP3A Inhibitors", "relevance"=>"LOW"}, {"id"=>"M30537", "name"=>"Cytochrome P-450 Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M4281", "name"=>"Antimetabolites", "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"=>"DOUBLE"}, "primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>46}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2021-10", "completionDateStruct"=>{"date"=>"1999-05", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2021-10-27", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2021-10-29", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Vaccines, Synthetic", "Didanosine", "Drug Therapy, Combination", "HIV Envelope Protein gp160", "Acquired Immunodeficiency Syndrome", "AIDS-Related Complex", "Stavudine", "HIV Protease Inhibitors", "AIDS Vaccines", "Ritonavir", "Reverse Transcriptase Inhibitors", "HIV Therapeutic Vaccine"], "conditions"=>["HIV Infections"]}, "referencesModule"=>{"references"=>[{"type"=>"BACKGROUND", "citation"=>"Katzenstein D, Valentine F, Kundu S, Haslett P, Smith G, Merigan T. Delayed-type-hypersensitivity reactions to intradermal gp160 in HIV infected individuals immunized with gp160. Int Conf AIDS. 1992 Jul 19-24;8(2):A35 (abstract no PoA 2192)"}, {"pmid"=>"11679149", "type"=>"BACKGROUND", "citation"=>"Kundu-Raychaudhuri S, Sevin A, Kilgo P, Nokta M, Pollard RB, Merigan TC. Effect of therapeutic immunization with HIV type 1 recombinant glycoprotein 160 ImmunoAG vaccine in HIV-infected individuals with CD4+ T cell counts of >or=500 and 200-400/mm3 (AIDS Clinical Trials Group Study 246/946). AIDS Res Hum Retroviruses. 2001 Oct 10;17(15):1371-8. doi: 10.1089/088922201753197033."}]}, "descriptionModule"=>{"briefSummary"=>"To evaluate the safety and immunogenicity of HIV-1 MN rgp160 (Immuno-AG) in HIV-infected patients. To evaluate the immunogenicity of HIV-1 MN rgp160 immunogen by lymphocyte proliferation, specific antibody responses, and DTH reaction. To describe the durability of the immunogen in patients who respond to the first 7 injections when they are boosted every 8 weeks for an additional 6-12 months \\[AS PER AMENDMENT 11/12/96: stratum 1 patients only\\]. To describe the ability of the immunogen to induce a response after an additional 6-12 months of injections among patients who did not respond to the first 7 injections \\[AS PER AMENDMENT 11/12/96: stratum 1 patients only\\].\n\nHIV-specific cellular immune responses appear to play an important role in HIV disease progression since both T helper and cytotoxic function against HIV decrease with disease progression.", "detailedDescription"=>"HIV-specific cellular immune responses appear to play an important role in HIV disease progression since both T helper and cytotoxic function against HIV decrease with disease progression.\n\nPatients with CD4 counts greater than or equal to 500 cells/mm3 are randomized to receive HIV-1 MN rgp160 (Immuno-AG) or control. Patients with CD4 counts 50-499 cells/mm3 receive didanosine (ddI) and are then randomized to receive ddI plus vaccine or control. Vaccine or control is given every 4 weeks for 7 injections, then every 8 weeks for 6-12 months or until 1 year after the last patient is randomized. AS PER AMENDMENT 11/12/96: Stratum 1 is composed of 16 subjects with CD4+ T cells greater than or equal to 500 mm3. These subjects are randomized to vaccine therapy or vaccine control. HIV-1 MN rgp160 vaccine or control is given every 4 weeks for 7 injections (Schedule 1), then every 8 weeks until 52 weeks after the last subject has been randomized to stratum 1 (Schedule 2). Stratum 1 patients receive ddI or d4T only if their CD4 cell count has a sustained decrease on 2 consecutive occasions 10-14 days apart and/or HIV/RNA plasma viral load increases to greater than 10,000 copies/ml on 2 consecutive occasions 10-14 days apart. Stratum 2 is composed of 30 subjects with CD4+ T cells 200-400/mm3; accrual to this stratum was activated based on preliminary results from stratum 1 (closed as of 4/5/97). Patients on stratum 2 (open as of 3/4/97) initially receive ritonavir at escalating doses for 2 weeks. Subjects then have ddI and d4T added to the regimen for 7 weeks. Subjects are then randomized to vaccine therapy or vaccine control every 4 weeks for 7 injections, with ritonavir/ddI/d4T continued during vaccine therapy.\n\nAS PER AMENDMENT 3/23/98: As of 6/1/98 vaccine consists of sodium chloride for injection (USP)."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "minimumAge"=>"13 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* ddI \\[AS PER AMENDMENT 11/12/96: and d4T\\]. (Note:\n* Patients in the stratum receiving only vaccine or control may take ddI \\[AS PER AMENDMENT 11/12/96:\n* and d4T\\] ONLY IF their CD4 counts have shown a sustained decrease on two consecutive occasions 10-14 days apart.)\n* PCP prophylaxis.\n* Treatment for acute conditions, as indicated.\n\nAS PER AMENDMENT 11/12/96:\n\n* Co-enrollment on other research trials.\n\nPatients must have:\n\n* HIV positivity.\n* Asymptomatic disease.\n* CD4 count \\>= 50 cells/mm3 (CD4 count must be 50-499 cells/mm3 in patients receiving ddI plus vaccine or control, and must be \\>= 500 cells/mm3 in patients receiving vaccine or control only)\n\n\\[AS PER AMENDMENT 11/12/96:\n\n* CD4 count \\>= 500 cells/mm3 for stratum 1 patients and 200-400 for stratum 2 patients\\].\n* HLA A2 positive documentation.\n* An Epstein Barr virus B cell line established within 90 days prior to study entry.\n* Consent of parent or guardian if less than 18 years of age.\n\nNOTE:\n\n* Study is NOT approved for prisoner participation.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\n* Medical contraindication to study participation or inability to comply with study requirements.\n* Grade 2 or worse peripheral neuropathy (applicable only to patients receiving ddI plus vaccine or control).\n\nConcurrent Medication:\n\nExcluded:\n\n* Immunomodulating agents, such as inosiplex, ditiocarb sodium, lithium, interferons, interleukin-2, and systemic steroids.\n* Any antiretroviral therapy that may increase the risk of peripheral neuropathy (e.g., stavudine, zalcitabine \\[AS PER AMENDMENT 11/12/96:\n* e.g., zalcitabine or lamivudine\\]).\n* Agents such as IV pentamidine that may increase the risk of pancreatitis.\n* Standard of care vaccines (in patients receiving vaccine) \\[AS PER AMENDMENT 11/12/96:\n* Standard of care immunizations are permitted 60 days before Schedule 1 vaccine therapy and during Schedule 2 vaccine therapy (but not within 2 weeks of study immunization)\\].\n\nAS PER AMENDMENT 11/12/96:\n\n* Rifabutin, disulfiram (antabuse), or other medication with similar effects, including metronidazole.\n\n 6.AS PER AMENDMENT 11/12/96:\n* The following are prohibited in patients receiving ritonavir:\n* amiodarone, astemizole, bepridil, bupropion, cisapride, clozapine, encainide, flecainide, meperidine, piroxicam, propafenone, propoxyphene, quinidine, rifabutin, terfenadine, alprazolam, clorazepate, diazepam, estazolam, flurazepam, midazolam, triazolam, and zolpidem.\n\nPatients with the following prior conditions are excluded:\n\n* History of grade 2 or worse liver abnormality.\n* Known allergy to vaccine components.\n* Chronic diarrhea persisting for 4 or more weeks within 30 days prior to study entry.\n* History of pancreatitis (applicable only to patients receiving ddI plus vaccine or control). \\[AS PER AMENDMENT 11/12/96:\n* History of chronic pancreatitis or history of acute pancreatitis within 2 years prior to entry (stratum 2 patients only).\\]\n\nPrior Medication:\n\nExcluded:\n\n* Any prior anti-HIV vaccines.\n\nExcluded within 90 days prior to study entry:\n\n* Immunomodulating agents, such as Inosiplex, ditiocarb sodium, lithium, interferons, interleukin-2, and systemic steroids.\n* Any antiretroviral therapy that may increase the risk of peripheral neuropathy (e.g., stavudine, zalcitabine \\[AS PER AMENDMENT 11/12/96:\n* e.g., zalcitabine or lamivudine\\]).\n* Agents such as IV pentamidine that may increase the risk of pancreatitis.\n* Any treatment for an AIDS-defining illness (applicable ONLY to patients in the stratum receiving ddI plus vaccine or control).\n\nExcluded within 6 months prior to study entry:\n\n* Any other antiretrovirals or immunomodulators besides those mentioned above.\n* Allergy desensitization or other vaccines \\[AS\n\nPER AMENDMENT 11/12/96:\n\n* excluded within 60 days prior to entry\\]."}, "identificationModule"=>{"nctId"=>"NCT00000822", "briefTitle"=>"A Phase I/II Double-Blind Controlled Trial to Determine the Safety and Immunogenicity of HIV-1 MN rgp160 Immuno AG Vaccine Therapy in HIV-Infected Individuals With Greater Than or Equal to 500/mm3 CD4+ T Cells and 200-400/mm3 CD4+ T Cells", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "officialTitle"=>"A Phase I/II Double-Blind Controlled Trial to Determine the Safety and Immunogenicity of HIV-1 MN rgp160 Immuno AG Vaccine Therapy in HIV-Infected Individuals With Greater Than or Equal to 500/mm3 CD4+ T Cells and 200-400/mm3 CD4+ T Cells", "orgStudyIdInfo"=>{"id"=>"ACTG 246/946"}, "secondaryIdInfos"=>[{"id"=>"11223", "type"=>"REGISTRY", "domain"=>"DAIDS ES Registry Number"}, {"id"=>"11499", "type"=>"REGISTRY", "domain"=>"DAIDS ES Registry Number"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Ritonavir", "type"=>"DRUG"}, {"name"=>"gp160 Vaccine (Immuno-AG)", "type"=>"BIOLOGICAL"}, {"name"=>"Stavudine", "type"=>"DRUG"}, {"name"=>"Didanosine", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"943055107", "city"=>"Stanford", "state"=>"California", "country"=>"United States", "facility"=>"Stanford CRS", "geoPoint"=>{"lat"=>37.42411, "lon"=>-122.16608}}], "overallOfficials"=>[{"name"=>"Kundu Smriti", "role"=>"STUDY_CHAIR"}, {"name"=>"Merigan T", "role"=>"STUDY_CHAIR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}, "collaborators"=>[{"name"=>"Bristol-Myers Squibb", "class"=>"INDUSTRY"}, {"name"=>"Immuno-US", "class"=>"INDUSTRY"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
