Nctid:
NCT00000834
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D007239", "term"=>"Infections"}, {"id"=>"D003141", "term"=>"Communicable Diseases"}, {"id"=>"D015658", "term"=>"HIV Infections"}, {"id"=>"D000163", "term"=>"Acquired Immunodeficiency Syndrome"}], "ancestors"=>[{"id"=>"D020969", "term"=>"Disease Attributes"}, {"id"=>"D010335", "term"=>"Pathologic Processes"}, {"id"=>"D000086982", "term"=>"Blood-Borne 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"}, {"id"=>"D012897", "term"=>"Slow Virus Diseases"}], "browseLeaves"=>[{"id"=>"M10283", "name"=>"Infections", "asFound"=>"Infection", "relevance"=>"HIGH"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "asFound"=>"Infection", "relevance"=>"HIGH"}, {"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "asFound"=>"HIV Infections", "relevance"=>"HIGH"}, {"id"=>"M18250", "name"=>"HIV Infections", "asFound"=>"HIV Infections", "relevance"=>"HIGH"}, {"id"=>"M20559", "name"=>"Disease Progression", "relevance"=>"LOW"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M3735", "name"=>"AIDS-Related Complex", "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"=>{"meshes"=>[{"id"=>"D019259", "term"=>"Lamivudine"}, {"id"=>"D015215", "term"=>"Zidovudine"}, {"id"=>"D008727", "term"=>"Methotrexate"}], "ancestors"=>[{"id"=>"D000020", "term"=>"Abortifacient Agents, Nonsteroidal"}, {"id"=>"D000019", "term"=>"Abortifacient Agents"}, {"id"=>"D012102", "term"=>"Reproductive Control Agents"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000964", "term"=>"Antimetabolites, Antineoplastic"}, {"id"=>"D000963", "term"=>"Antimetabolites"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D003879", "term"=>"Dermatologic Agents"}, {"id"=>"D004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D005493", "term"=>"Folic Acid Antagonists"}, {"id"=>"D007166", "term"=>"Immunosuppressive Agents"}, {"id"=>"D007155", "term"=>"Immunologic Factors"}, {"id"=>"D018501", "term"=>"Antirheumatic Agents"}, {"id"=>"D019384", "term"=>"Nucleic Acid Synthesis Inhibitors"}, {"id"=>"D018894", "term"=>"Reverse Transcriptase Inhibitors"}, {"id"=>"D000998", "term"=>"Antiviral Agents"}, {"id"=>"D000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D019380", "term"=>"Anti-HIV Agents"}, {"id"=>"D044966", "term"=>"Anti-Retroviral Agents"}], "browseLeaves"=>[{"id"=>"M11703", "name"=>"Methotrexate", "asFound"=>"Brain", "relevance"=>"HIGH"}, {"id"=>"M4217", "name"=>"Anti-Inflammatory Agents", "relevance"=>"LOW"}, {"id"=>"M21243", "name"=>"Lamivudine", "asFound"=>"Next", "relevance"=>"HIGH"}, {"id"=>"M21350", "name"=>"Anti-HIV Agents", "relevance"=>"LOW"}, {"id"=>"M17920", "name"=>"Zidovudine", "asFound"=>"Corticosteroid", "relevance"=>"HIGH"}, {"id"=>"M4281", "name"=>"Antimetabolites", "relevance"=>"LOW"}, {"id"=>"M7074", "name"=>"Dermatologic Agents", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M8618", "name"=>"Folic Acid", "relevance"=>"LOW"}, {"id"=>"M17546", "name"=>"Vitamin B Complex", "relevance"=>"LOW"}, {"id"=>"M8619", "name"=>"Folic Acid Antagonists", "relevance"=>"LOW"}, {"id"=>"M10212", "name"=>"Immunosuppressive Agents", "relevance"=>"LOW"}, {"id"=>"M10201", "name"=>"Immunologic Factors", "relevance"=>"LOW"}, {"id"=>"M20604", "name"=>"Antirheumatic Agents", "relevance"=>"LOW"}, {"id"=>"M20935", "name"=>"Reverse Transcriptase Inhibitors", "relevance"=>"LOW"}, {"id"=>"M4314", "name"=>"Antiviral Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M25428", "name"=>"Anti-Retroviral Agents", "relevance"=>"LOW"}, {"id"=>"T446", "name"=>"Folic Acid", "relevance"=>"LOW"}, {"id"=>"T447", "name"=>"Folinic Acid", "relevance"=>"LOW"}, {"id"=>"T448", "name"=>"Folate", "relevance"=>"LOW"}, {"id"=>"T475", "name"=>"Vitamin B9", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"Antirheumatic Agents", "abbrev"=>"ARhu"}, {"name"=>"Dermatologic Agents", "abbrev"=>"Derm"}, {"name"=>"Reproductive Control Agents", "abbrev"=>"Repr"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Anti-Inflammatory Agents", "abbrev"=>"Infl"}, {"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"Micronutrients", "abbrev"=>"Micro"}, {"name"=>"Hematinics", "abbrev"=>"Hemat"}, {"name"=>"Vitamins", "abbrev"=>"Vi"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>30}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2021-10", "completionDateStruct"=>{"date"=>"2002-06", "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"=>["Methotrexate", "Acquired Immunodeficiency Syndrome", "AIDS-Related Complex", "Zidovudine", "Lamivudine", "Disease Progression", "Anti-Inflammatory Agents", "Anti-HIV Agents"], "conditions"=>["HIV Infections"]}, "descriptionModule"=>{"briefSummary"=>"To determine the safety and tolerance of methotrexate in HIV-infected patients. To determine the dose effective in modulating key markers of immune activation. To determine a dose suitable for Phase II or III evaluation in HIV-infected patients.\n\nIn HIV infection, complete immunological clearance of the foreign antigen does not occur, resulting in chronic immune activation. Because chronic immune activation may contribute to disease progression in HIV infection, immunomodulators may have therapeutic value in early HIV disease prior to development of opportunistic infections. The clinical benefits of methotrexate appear to derive from an anti-inflammatory effect; thus, it may reduce the state of chronic immune activation.", "detailedDescription"=>"In HIV infection, complete immunological clearance of the foreign antigen does not occur, resulting in chronic immune activation. Because chronic immune activation may contribute to disease progression in HIV infection, immunomodulators may have therapeutic value in early HIV disease prior to development of opportunistic infections. The clinical benefits of methotrexate appear to derive from an anti-inflammatory effect; thus, it may reduce the state of chronic immune activation.\n\nPatients are randomized to receive methotrexate at Dose 1 or 2 (low doses) for 12 weeks, with 8 weeks of follow-up. If interim safety monitoring and viral burden results for the two cohorts support continuation, a third cohort of patients receive methotrexate starting at Dose 2 for the first 2 weeks, then at Dose 3 for the next 2 weeks, and at Dose 4 for the remaining 8 weeks, with 8 weeks of follow-up.\n\nAS PER AMENDMENT 1/10/97:\n\nThe Dose 1 (the lowest dose) has been eliminated; the first 10 patients are now assigned to the next higher dose. Depending upon the results of interim safety data, the next cohort will be entered on the escalating dose regimen.\n\nAlso per this amendment, all patients will receive zidovudine and lamivudine for 30 days prior to the initiation of methotrexate, during the 12 weeks of methotrexate administration, and for the 8 weeks of follow-up."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Antiemetics and antidiarrheals.\n* Acetaminophen.\n* Oral hypoglycemic agents.\n\nPER AMENDMENT 5/15/96:\n\n* Stable dose of antiretroviral (must be stable for at least 1 month prior to study entry). \\[AS\n\nPER AMENDMENT 1/10/97:\n\n* Combination zidovudine/lamivudine or zidovudine alone.\\]\n\nPatients must have:\n\n* HIV seropositivity.\n* CD4 count \\>= 300 cells/mm3.\n* No AIDS-defining condition.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptom or condition are excluded:\n\n* Current positive PPD.\n\nConcurrent Medication:\n\nExcluded:\n\n* Immunosuppressive or immunomodulatory drugs.\n* Chronic nonsteroidal anti-inflammatory agents.\n* Newly initiated antiretrovirals.\n* Bone marrow suppressive drugs (e.g., TMP/SMX).\n\nConcurrent Treatment:\n\nAS PER AMENDMENT 1/10/97: Excluded:\n\n* Antiretroviral therapy other than combination zidovudine/lamivudine or zidovudine alone; no initiation of other antiretroviral therapy should be planned while patient is on methotrexate.\n\nPatients with the following prior conditions are excluded:\n\n* Prior malignancies.\n* Prior mucocutaneous herpes infection requiring antiviral therapy \\[AS PER AMENDMENT 7/31/96: Prior mucocutaneous herpes infection requiring systemic treatment with an antiviral agent (e.g., acyclovir); history of topical antiviral therapy is permitted\\].\n* Anergic on DTH skin test within the past month (PER AMENDMENT 5/15/96: patients who are positive on DTH skin test but unable to receive the HIV-1 skin test because of allergies to insects, bee stings, etc., remain eligible for study enrollment).\n* Inflammatory bowel disease, peptic ulcer disease, obesity combined with insulin-requiring diabetes, liver disease, or chronic renal disease within the past 6 months.\n* Positive for HBsAg or hepatitis C antibody within the past 2 weeks.\n* Chest radiograph within the past 60 days that shows cavity disease, infiltrates, or scars from prior disease that would preclude diagnosis of a new infectious process or drug-induced pneumonitis.\n\nAS PER AMENDMENT 1/10/97:\n\n* History of intolerance to zidovudine or lamivudine.\n\nPrior Medication:\n\nExcluded:\n\n* Prior chemotherapy for malignancy.\n\nPrior Treatment:\n\nExcluded:\n\n* Prior radiotherapy for malignancy. Alcohol abuse."}, "identificationModule"=>{"nctId"=>"NCT00000834", "briefTitle"=>"A Phase I Study of Methotrexate for HIV Infection", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "officialTitle"=>"A Phase I Study of Methotrexate for HIV Infection", "orgStudyIdInfo"=>{"id"=>"DATRI 013"}, "secondaryIdInfos"=>[{"id"=>"11742", "type"=>"REGISTRY", "domain"=>"DAIDS ES Registry Number"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Lamivudine", "type"=>"DRUG"}, {"name"=>"Methotrexate", "type"=>"DRUG"}, {"name"=>"Zidovudine", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"90048", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"Cedars Sinai Med Ctr", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"20007", "city"=>"Washington", "state"=>"District of Columbia", "country"=>"United States", "facility"=>"Georgetown Univ Med Ctr", "geoPoint"=>{"lat"=>38.89511, "lon"=>-77.03637}}, {"zip"=>"67214", "city"=>"Wichita", "state"=>"Kansas", "country"=>"United States", "facility"=>"Univ of Kansas School of Medicine", "geoPoint"=>{"lat"=>37.69224, "lon"=>-97.33754}}, {"zip"=>"02111", "city"=>"Boston", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"New England Med Ctr", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}, {"zip"=>"48201", "city"=>"Detroit", "state"=>"Michigan", "country"=>"United States", "facility"=>"Harper Hosp", "geoPoint"=>{"lat"=>42.33143, "lon"=>-83.04575}}, {"zip"=>"10001", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Community Research Initiative on AIDS", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"75235", "city"=>"Dallas", "state"=>"Texas", "country"=>"United States", "facility"=>"Univ of Texas Southwestern Med Ctr of Dallas", "geoPoint"=>{"lat"=>32.78306, "lon"=>-96.80667}}], "overallOfficials"=>[{"name"=>"Egorin M", "role"=>"STUDY_CHAIR"}, {"name"=>"Fox L", "role"=>"STUDY_CHAIR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
