Nctid:
NCT00000842
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-09-05"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000009422", "term"=>"Nervous System Diseases"}, {"id"=>"D000010523", "term"=>"Peripheral Nervous System Diseases"}], "ancestors"=>[{"id"=>"D000009468", "term"=>"Neuromuscular 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", "relevance"=>"LOW"}, {"id"=>"M13432", "name"=>"Peripheral Nervous System Diseases", "asFound"=>"Peripheral Nervous System Diseases", "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"=>"M12411", "name"=>"Neuromuscular 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"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000008934", "term"=>"Mitogens"}], "ancestors"=>[{"id"=>"D000050258", "term"=>"Mitosis Modulators"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}], "browseLeaves"=>[{"id"=>"M11900", "name"=>"Mitogens", "asFound"=>"Antigen", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"maskingInfo"=>{"masking"=>"DOUBLE"}, "primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>270}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2021-10", "completionDateStruct"=>{"date"=>"1999-02", "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"=>["Acquired Immunodeficiency Syndrome", "AIDS-Related Complex", "Peripheral Nervous System Diseases", "Nerve Growth Factors", "Growth Substances"], "conditions"=>["HIV Infections", "Peripheral Nervous System Disease"]}, "referencesModule"=>{"references"=>[{"pmid"=>"11364013", "type"=>"BACKGROUND", "citation"=>"Nerve growth factor study opens. GMHC Treat Issues. 1996 Nov;10(11):9."}, {"pmid"=>"11362992", "type"=>"BACKGROUND", "citation"=>"Gilden D. Hyperthermia study finds little effect. GMHC Treat Issues. 1995 Nov;9(11):5-7."}, {"pmid"=>"11362404", "type"=>"BACKGROUND", "citation"=>"James JS. Nerve growth factor: major trial canceled, revived after protest. AIDS Treat News. 1995 Apr 21;(no 221):5."}, {"pmid"=>"11834952", "type"=>"BACKGROUND", "citation"=>"Simpson DM, Haidich AB, Schifitto G, Yiannoutsos CT, Geraci AP, McArthur JC, Katzenstein DA; ACTG 291 study team. Severity of HIV-associated neuropathy is associated with plasma HIV-1 RNA levels. AIDS. 2002 Feb 15;16(3):407-12. doi: 10.1097/00002030-200202150-00012."}, {"pmid"=>"11362419", "type"=>"BACKGROUND", "citation"=>"Lein B. Potential therapy for painful neuropathy. PI Perspect. 1995 May;(no 16):11."}, {"pmid"=>"10720278", "type"=>"BACKGROUND", "citation"=>"McArthur JC, Yiannoutsos C, Simpson DM, Adornato BT, Singer EJ, Hollander H, Marra C, Rubin M, Cohen BA, Tucker T, Navia BA, Schifitto G, Katzenstein D, Rask C, Zaborski L, Smith ME, Shriver S, Millar L, Clifford DB, Karalnik IJ. A phase II trial of nerve growth factor for sensory neuropathy associated with HIV infection. AIDS Clinical Trials Group Team 291. Neurology. 2000 Mar 14;54(5):1080-8. doi: 10.1212/wnl.54.5.1080. Erratum In: Neurology 2000 Jul 13;55(1):162."}]}, "descriptionModule"=>{"briefSummary"=>"To assess the efficacy, safety, and tolerability of recombinant human nerve growth factor ( rhNGF ) in the treatment of HIV-associated sensory neuropathy. AS PER AMENDMENT 5/6/97: To compare the change in viral load between the double-blind phase baseline and week 4 in placebo and active rhNGF recipients. To ensure that rhNGF does not induce an increase in viral load compared with viral load changes seen with placebo.\n\nUp to now, treatments for HIV-associated sensory neuropathy have been symptomatic, relying on pain-modifying agents or membrane-stabilizing drugs. Because nerve growth factor is important in the development and maintenance of sympathetic and sensory neurons and their outgrowths, it is proposed that recombinant human nerve growth factor may provide a specific restorative treatment for HIV-associated painful sensory neuropathy.", "detailedDescription"=>"Up to now, treatments for HIV-associated sensory neuropathy have been symptomatic, relying on pain-modifying agents or membrane-stabilizing drugs. Because nerve growth factor is important in the development and maintenance of sympathetic and sensory neurons and their outgrowths, it is proposed that recombinant human nerve growth factor may provide a specific restorative treatment for HIV-associated painful sensory neuropathy.\n\nPatients are randomized to receive either rhNGF at one of two doses or placebo, administered subcutaneously twice weekly for 18 weeks. Patients are stratified into three groups within their regimens by use of didanosine, zalcitabine, or stavudine as follows: current use vs. discontinued between 8 and 26 weeks before randomization vs. never used or discontinued use at least 26 weeks before randomization. Patients will assess their pain daily using the Gracely Pain Scale. AS PER AMENDMENT 5/6/97: After completion of the double-blind phase (18 weeks on treatment followed by 4 weeks off treatment), patients may receive open-label, active drug treatment according to their previously assigned regimen for an additional 48 weeks."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"70 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Maintenance treatment of CMV retinitis, MAI bacteremia, or cryptococcal meningitis is permitted.\n* Local therapy for Kaposi's sarcoma.\n\nPatients must have:\n\n* Evidence of HIV antibodies documented by a licensed ELISA and a second, FDA-approved, confirmatory test.\n* Diagnosis of HIV-associated, predominantly sensory neuropathy by a neurologist.\n* Willingness and ability to complete the pain and medication log and competence to assess pain level throughout the study.\n\nPrior Medication:\n\nAllowed:\n\n* History of stable-dose (defined as no more than 50% increase or decrease in dose) antiretroviral therapy for eight weeks before randomization, including the following:\n* didanosine, zalcitabine, stavudine, lamivudine, protease inhibitors, and antiretrovirals available through expanded access trials.\n* Chemotherapeutic drugs other than neurotoxic systemic chemotherapeutic agents within 30 days prior to randomization.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\n* Presence of acute, active, opportunistic infection, except oral thrush; oral, genital or rectal herpes; and MAI bacteremia within two weeks before randomization.\n* Evidence of another contributing cause for peripheral neuropathy, including:\n* diabetes mellitus, hereditary neuropathy, current vitamin B12 deficiency and no supplementation or supplementation \\<= 3 months, or treatment with any drug that might contribute to sensory neuropathy.\n* Major active psychiatric disorder (depression is allowed provided patient has received a stable antidepressant regimen for at least four weeks before randomization).\n* Current active malignancy. NOTE: Malignancies in remission that do not require further treatment or Kaposi's sarcoma requiring only local treatment are allowed.\n* Any conditions, including dementia and myelopathy, that would interfere with patient evaluation, accurate completion of the symptom scale, or compliance with subcutaneous injection.\n\nConcurrent Medication:\n\nExcluded:\n\n* Chemotherapeutic agents.\n* Systemic corticosteroids or immunomodulators.\n* Initiation of new antiretroviral to a stable regimen.\n\nPrior Medication:\n\nExcluded:\n\n* Neurotoxic systemic chemotherapy within the past 90 days.\n* Systemic corticosteroids or immunomodulators within the past 30 days.\n* Initiation of non-opioid prescription medication for pain during the 2 weeks preceding randomization (including tricyclic antidepressants, mexiletine, phenytoin, and carbamazepine).\n* Treatment for acute opportunistic infections within the past 14 days (maintenance therapy for CMV retinitis, MAI bacteremia, or cryptococcal meningitis is permitted).\n\nActive drug or alcohol abuse that would affect study compliance."}, "identificationModule"=>{"nctId"=>"NCT00000842", "briefTitle"=>"A Phase II, Double-Blind Trial of Recombinant Human Nerve Growth Factor for Treatment of HIV-Associated Sensory Neuropathy", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "officialTitle"=>"A Phase II, Double-Blind Trial of Recombinant Human Nerve Growth Factor for Treatment of HIV-Associated Sensory Neuropathy", "orgStudyIdInfo"=>{"id"=>"ACTG 291"}, "secondaryIdInfos"=>[{"id"=>"11267", "type"=>"REGISTRY", "domain"=>"DAIDS ES Registry Number"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Nerve Growth Factor, Recombinant Human", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"90095", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"UCLA CARE Center CRS", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"city"=>"San Mateo", "state"=>"California", "country"=>"United States", "facility"=>"San Mateo County AIDS Program", "geoPoint"=>{"lat"=>37.56299, "lon"=>-122.32553}}, {"zip"=>"943055107", "city"=>"Stanford", "state"=>"California", "country"=>"United States", "facility"=>"Stanford CRS", "geoPoint"=>{"lat"=>37.42411, "lon"=>-122.16608}}, {"zip"=>"60611", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Northwestern University CRS", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"21287", "city"=>"Baltimore", "state"=>"Maryland", "country"=>"United States", "facility"=>"Johns Hopkins Adult AIDS CRS", "geoPoint"=>{"lat"=>39.29038, "lon"=>-76.61219}}, {"zip"=>"02215", "city"=>"Boston", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Beth Israel Deaconess - East Campus A0102 CRS", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}, {"city"=>"Saint Louis", "state"=>"Missouri", "country"=>"United States", "facility"=>"Washington U CRS", "geoPoint"=>{"lat"=>38.62727, "lon"=>-90.19789}}, {"zip"=>"10016", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"NY Univ. HIV/AIDS CRS", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Cornell University A2201", "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}}, {"zip"=>"275997215", "city"=>"Chapel Hill", "state"=>"North Carolina", "country"=>"United States", "facility"=>"Unc Aids Crs", "geoPoint"=>{"lat"=>35.9132, "lon"=>-79.05584}}, {"zip"=>"44106", "city"=>"Cleveland", "state"=>"Ohio", "country"=>"United States", "facility"=>"Case CRS", "geoPoint"=>{"lat"=>41.4995, "lon"=>-81.69541}}, {"zip"=>"432101228", "city"=>"Columbus", "state"=>"Ohio", "country"=>"United States", "facility"=>"The Ohio State Univ. AIDS CRS", "geoPoint"=>{"lat"=>39.96118, "lon"=>-82.99879}}, {"zip"=>"981224304", "city"=>"Seattle", "state"=>"Washington", "country"=>"United States", "facility"=>"University of Washington AIDS CRS", "geoPoint"=>{"lat"=>47.60621, "lon"=>-122.33207}}], "overallOfficials"=>[{"name"=>"McArthur J", "role"=>"STUDY_CHAIR"}, {"name"=>"Simpson D", "role"=>"STUDY_CHAIR"}, {"name"=>"Schifitto G", "role"=>"STUDY_CHAIR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}