Nctid:
NCT00000953
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D002644", "term"=>"Chickenpox"}], "ancestors"=>[{"id"=>"D007239", "term"=>"Infections"}, {"id"=>"D014777", "term"=>"Virus Diseases"}, {"id"=>"D000073618", "term"=>"Varicella Zoster Virus Infection"}, {"id"=>"D006566", "term"=>"Herpesviridae Infections"}, {"id"=>"D004266", "term"=>"DNA Virus Infections"}], "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"=>"M9639", "name"=>"Herpes Simplex", "relevance"=>"LOW"}, {"id"=>"M5888", "name"=>"Chickenpox", "asFound"=>"Chickenpox", "relevance"=>"HIGH"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M9640", "name"=>"Herpes Zoster", "relevance"=>"LOW"}, {"id"=>"M3735", "name"=>"AIDS-Related Complex", "relevance"=>"LOW"}, {"id"=>"M17522", "name"=>"Virus Diseases", "relevance"=>"LOW"}, {"id"=>"M1200", "name"=>"Varicella Zoster Virus Infection", "relevance"=>"LOW"}, {"id"=>"M9643", "name"=>"Herpesviridae Infections", "relevance"=>"LOW"}, {"id"=>"M7442", "name"=>"DNA Virus Infections", "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"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000212", "term"=>"Acyclovir"}, {"id"=>"C031368", "term"=>"Sorivudine"}], "ancestors"=>[{"id"=>"D000998", "term"=>"Antiviral Agents"}, {"id"=>"D000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}], "browseLeaves"=>[{"id"=>"M3567", "name"=>"Acyclovir", "asFound"=>"Polysaccharide", "relevance"=>"HIGH"}, {"id"=>"M4314", "name"=>"Antiviral Agents", "relevance"=>"LOW"}, {"id"=>"M340802", "name"=>"Sorivudine", "asFound"=>"Imsidolimab", "relevance"=>"HIGH"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>180}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2011-02", "lastUpdateSubmitDate"=>"2011-02-25", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2011-03-01", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}, "primaryCompletionDateStruct"=>{"date"=>"1996-09", "type"=>"ACTUAL"}}, "conditionsModule"=>{"keywords"=>["Herpes Zoster", "Acyclovir", "Acquired Immunodeficiency Syndrome", "AIDS-Related Complex", "Antiviral Agents", "sorivudine"], "conditions"=>["HIV Infections", "Chickenpox"]}, "referencesModule"=>{"references"=>[{"type"=>"BACKGROUND", "citation"=>"Gnann J, et al. Sorivudine (BV-araU) versus acyclovir for Herpes zoster in HIV-infected patients. Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:55"}]}, "descriptionModule"=>{"briefSummary"=>"To compare the efficacy of oral sorivudine (brovavir) and oral acyclovir for the treatment of localized herpes zoster in HIV-infected patients.\n\nHIV-infected patients are at high risk for herpesvirus infections, including varicella-zoster virus ( VZV ) infections, also called shingles. Acyclovir, an approved drug, is widely used to treat VZV infections in the HIV population. Since no data from controlled studies are available to define the role of antiviral therapy for VZV infections in HIV-infected patients, a study is needed to test the relative efficacy of brovavir, an experimental antiviral drug, versus that of acyclovir.", "detailedDescription"=>"HIV-infected patients are at high risk for herpesvirus infections, including varicella-zoster virus ( VZV ) infections, also called shingles. Acyclovir, an approved drug, is widely used to treat VZV infections in the HIV population. Since no data from controlled studies are available to define the role of antiviral therapy for VZV infections in HIV-infected patients, a study is needed to test the relative efficacy of brovavir, an experimental antiviral drug, versus that of acyclovir.\n\nOne hundred-eighty patients are randomized to receive either brovavir or acyclovir as follows: brovavir or its matching placebo once daily and acyclovir or its matching placebo five times daily. Treatment continues for 10 days. Entry into the study must occur within 72 hours of lesion development. Patients are followed in person daily or at regular intervals during study drug administration and on days 14, 21, and 28, and then monthly by telephone for 11 months thereafter."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Medication for concurrent conditions (e.g., insulin, antihypertensives, bronchodilators, digoxin) or antibacterials or antifungals to treat concurrent infections at other sites or superinfection of the zoster lesion.\n* Anti-inflammatory, analgesic (including narcotic analgesic), or antipyretic agents.\n* Antidepressants and antipsychotics such as amitriptyline and/or fluphenazine.\n* Nerve blocks.\n* AZT, ddI, ddC, and amantadine.\n* Low-dose corticosteroids for treatment of an underlying (not zoster-related) disease.\n* Immune modulators without varicella-zoster virus activity (e.g., GM-CSF, gp160 vaccine).\n\nPatients must have:\n\n* HIV infection.\n* Localized, cutaneous herpes zoster (shingles).\n* Zoster-associated rash present for 3 or fewer days prior to entry.\n\nPrior Medication:\n\nAllowed:\n\n* Zidovudine.\n* ddI.\n* ddC.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following conditions and symptoms are excluded:\n\n* Chickenpox.\n* Evidence of visceral dissemination (organ involvement, i.e., brain, liver, or lung) and/or cutaneous dissemination (more than 20 vesicles in dermatomes beyond contiguous dermatomes) of zoster.\n* Zoster-like lesion caused by organism other than VZV (e.g., HSV, enterovirus, or Mycoplasma).\n* Bacterial superinfection of zoster lesion.\n* Zosteriform lesion previously treated with topical antiviral agents.\n* Acute, life-threatening opportunistic infection requiring treatment (ongoing suppressive or prophylactic maintenance therapy other than ganciclovir or foscarnet is permitted).\n* Concurrent severe disease that may either impair ability to take oral medication in capsule or tablet form or limit survival during the 10-day treatment period or during acute phase follow-up (28 days).\n* Suspected acute deterioration of renal or hepatic function.\n* Mental impairment that precludes ability to comply with protocol.\n* Any condition that would render the patient unsuitable for treatment.\n\nConcurrent Medication:\n\nExcluded during acute phase of study:\n\n* Antiviral medications other than AZT, ddI, ddC, or anti-Parkinson's drugs (i.e., amantadine).\n* Interferon.\n* Isoprinosine.\n* Levamisole.\n* Transfer factor.\n* Topical virucidal agents, oxidizing agents, DMSO, cell division-stimulating/healing agents, or astringents.\n* Topical anesthetics (such as capsaicin or xylocaine).\n* Topical creams or ointments that may interfere with evaluation of zoster lesions.\n* Cimetidine.\n* Fluorouracil or its derivatives, flucytosine, or cyclophosphamide (during drug administration and for 2 weeks thereafter).\n* High-dose corticosteroids.\n* Anticoagulant therapy (heparin locks and low-dose warfarin sodium permitted).\n* Probenecid or derivatives.\n* Treatment for any acute, life-threatening opportunistic infection (suppressive or prophylactic maintenance therapy other than ganciclovir or foscarnet is permitted).\n\nUse of the following drugs is discouraged during the long-term phase of the study:\n\n* Antiviral agents with VZV activity.\n* Immunomodulators with presumed VZV activity.\n* VZV immune globulin.\n* Capsaicin.\n* Cimetidine.\n\nPatients with the following prior conditions are excluded:\n\n* History of immediate hypersensitivity or serum sickness reaction or idiosyncratic reaction (such as hepatic necrosis or Stevens-Johnson syndrome) to any nucleoside analog antiviral agent or to any anticancer therapy with cytolytic agents.\n\nPrior Medication:\n\nExcluded within 1 month prior to entry:\n\n* Any investigational drugs or treatments not licensed for any indication (other than ddI or ddC).\n\nExcluded within 2 weeks prior to entry:\n\n* Any systemic antiviral therapy, including ganciclovir, foscarnet, vidarabine, acyclovir, or ribavirin.\n* Any antiretroviral drug other than zidovudine, ddI, and ddC.\n* Immune globulin (e.g., IgG, VZIG).\n\nExcluded within 72 hours prior to entry:\n\n* Cyclophosphamide.\n* Flucytosine.\n* Fluorouracil or its derivatives.\n\nAlcohol or drug abuse."}, "identificationModule"=>{"nctId"=>"NCT00000953", "briefTitle"=>"Comparison of Brovavir Versus Acyclovir in the Treatment of Herpes in HIV-Infected Patients", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "officialTitle"=>"Evaluation of Brovavir ( BV-ara-U; SQ 32,756 ) Versus Acyclovir in the Treatment of Localized Herpes Zoster in HIV-Infected Patients", "orgStudyIdInfo"=>{"id"=>"ACTG 169"}, "secondaryIdInfos"=>[{"id"=>"Protocol -38/-022"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Sorivudine", "type"=>"DRUG"}, {"name"=>"Acyclovir", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"35294", "city"=>"Birmingham", "state"=>"Alabama", "country"=>"United States", "facility"=>"Univ of Alabama at Birmingham", "geoPoint"=>{"lat"=>33.52066, "lon"=>-86.80249}}, {"zip"=>"900331079", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"Univ of Southern California / LA County USC Med Ctr", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"90095", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"UCLA Med Ctr", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"94553", "city"=>"Martinez", "state"=>"California", "country"=>"United States", "facility"=>"Veterans Administration Med Ctr", "geoPoint"=>{"lat"=>38.01937, "lon"=>-122.13413}}, {"zip"=>"94609", "city"=>"Oakland", "state"=>"California", "country"=>"United States", "facility"=>"Infectious Disease Med Group", "geoPoint"=>{"lat"=>37.80437, "lon"=>-122.2708}}, {"zip"=>"92134", "city"=>"San Diego", "state"=>"California", "country"=>"United States", "facility"=>"San Diego Naval Hosp", "geoPoint"=>{"lat"=>32.71533, "lon"=>-117.15726}}, {"zip"=>"94115", "city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"Mount Zion Med Ctr", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"80262", "city"=>"Denver", "state"=>"Colorado", "country"=>"United States", "facility"=>"Univ of Colorado Health Sciences Ctr", "geoPoint"=>{"lat"=>39.73915, "lon"=>-104.9847}}, {"zip"=>"20037", "city"=>"Washington", "state"=>"District of Columbia", "country"=>"United States", "facility"=>"George Washington Univ Med Ctr", "geoPoint"=>{"lat"=>38.89511, "lon"=>-77.03637}}, {"zip"=>"20422", "city"=>"Washington", "state"=>"District of Columbia", "country"=>"United States", "facility"=>"Veterans Administration Med Ctr / Community AIDS Program", "geoPoint"=>{"lat"=>38.89511, "lon"=>-77.03637}}, {"zip"=>"30912", "city"=>"Augusta", "state"=>"Georgia", "country"=>"United States", "facility"=>"Med College of Georgia", "geoPoint"=>{"lat"=>33.47097, "lon"=>-81.97484}}, {"zip"=>"96816", "city"=>"Honolulu", "state"=>"Hawaii", "country"=>"United States", "facility"=>"Univ of Hawaii / Leahi Hosp", "geoPoint"=>{"lat"=>21.30694, "lon"=>-157.85833}}, {"zip"=>"60612", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Rush Presbyterian - Saint Luke's Med Ctr", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"21205", "city"=>"Baltimore", "state"=>"Maryland", "country"=>"United States", "facility"=>"Johns Hopkins Hosp", "geoPoint"=>{"lat"=>39.29038, "lon"=>-76.61219}}, {"zip"=>"20892", "city"=>"Bethesda", "state"=>"Maryland", "country"=>"United States", "facility"=>"Natl Institutes of Health / NIAID", "geoPoint"=>{"lat"=>38.98067, "lon"=>-77.10026}}, {"zip"=>"02114", "city"=>"Boston", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Massachusetts Gen Hosp / Harvard Med School", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}, {"zip"=>"02215", "city"=>"Boston", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Beth Israel Hosp", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}, {"zip"=>"02215", "city"=>"Boston", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Brigham and Women's Hosp", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}, {"zip"=>"02215", "city"=>"Boston", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"New England Deaconess Hosp", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}, {"zip"=>"63108", "city"=>"St Louis", "state"=>"Missouri", "country"=>"United States", "facility"=>"Washington Univ", "geoPoint"=>{"lat"=>38.62727, "lon"=>-90.19789}}, {"zip"=>"87131", "city"=>"Albuquerque", "state"=>"New Mexico", "country"=>"United States", "facility"=>"Univ of New Mexico", "geoPoint"=>{"lat"=>35.08449, "lon"=>-106.65114}}, {"zip"=>"10003", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Beth Israel Med Ctr", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"10021", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Mem Sloan - Kettering Cancer Ctr", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"10025", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Saint Luke's - Roosevelt Hosp Ctr", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"10029", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Mount Sinai Med Ctr", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"11794", "city"=>"Stony Brook", "state"=>"New York", "country"=>"United States", "facility"=>"SUNY / Health Sciences Ctr at Stony Brook", "geoPoint"=>{"lat"=>40.92565, "lon"=>-73.14094}}, {"zip"=>"13210", "city"=>"Syracuse", "state"=>"New York", "country"=>"United States", "facility"=>"SUNY / Health Sciences Ctr at Syracuse", "geoPoint"=>{"lat"=>43.04812, "lon"=>-76.14742}}, {"zip"=>"28204", "city"=>"Charlotte", "state"=>"North Carolina", "country"=>"United States", "facility"=>"Carolinas Med Ctr", "geoPoint"=>{"lat"=>35.22709, "lon"=>-80.84313}}, {"zip"=>"452670523", "city"=>"Cincinnati", "state"=>"Ohio", "country"=>"United States", "facility"=>"Univ Dermatology Associates", "geoPoint"=>{"lat"=>39.12713, "lon"=>-84.51435}}, {"zip"=>"43210", "city"=>"Columbus", "state"=>"Ohio", "country"=>"United States", "facility"=>"Ohio State Univ / ACTU-Univ Clinic", "geoPoint"=>{"lat"=>39.96118, "lon"=>-82.99879}}, {"zip"=>"45428", "city"=>"Dayton", "state"=>"Ohio", "country"=>"United States", "facility"=>"Dayton Veterans Administration Med Ctr", "geoPoint"=>{"lat"=>39.75895, "lon"=>-84.19161}}, {"zip"=>"43699", "city"=>"Toledo", "state"=>"Ohio", "country"=>"United States", "facility"=>"Med College of Ohio", "geoPoint"=>{"lat"=>41.66394, "lon"=>-83.55521}}, {"zip"=>"972109951", "city"=>"Portland", "state"=>"Oregon", "country"=>"United States", "facility"=>"Portland Veterans Adm Med Ctr / Rsch & Education Grp", "geoPoint"=>{"lat"=>45.52345, "lon"=>-122.67621}}, {"zip"=>"75216", "city"=>"Dallas", "state"=>"Texas", "country"=>"United States", "facility"=>"Dallas Veterans Administration Med Ctr", "geoPoint"=>{"lat"=>32.78306, "lon"=>-96.80667}}, {"zip"=>"75390", "city"=>"Dallas", "state"=>"Texas", "country"=>"United States", "facility"=>"Univ of Texas, Southwestern Med Ctr of Dallas", "geoPoint"=>{"lat"=>32.78306, "lon"=>-96.80667}}, {"zip"=>"775550882", "city"=>"Galveston", "state"=>"Texas", "country"=>"United States", "facility"=>"Univ TX Galveston Med Branch", "geoPoint"=>{"lat"=>29.30135, "lon"=>-94.7977}}, {"zip"=>"77030", "city"=>"Houston", "state"=>"Texas", "country"=>"United States", "facility"=>"Baylor College of Medicine", "geoPoint"=>{"lat"=>29.76328, "lon"=>-95.36327}}, {"zip"=>"782847881", "city"=>"San Antonio", "state"=>"Texas", "country"=>"United States", "facility"=>"Univ TX San Antonio Health Science Ctr", "geoPoint"=>{"lat"=>29.42412, "lon"=>-98.49363}}, {"zip"=>"76508", "city"=>"Temple", "state"=>"Texas", "country"=>"United States", "facility"=>"Scott and White Hosp", "geoPoint"=>{"lat"=>31.09823, "lon"=>-97.34278}}, {"zip"=>"22908", "city"=>"Charlottesville", "state"=>"Virginia", "country"=>"United States", "facility"=>"Univ of Virginia Health Sciences Ctr", "geoPoint"=>{"lat"=>38.02931, "lon"=>-78.47668}}, {"zip"=>"23507", "city"=>"Norfolk", "state"=>"Virginia", "country"=>"United States", "facility"=>"Virginia Clinical Research Inc", "geoPoint"=>{"lat"=>36.84681, "lon"=>-76.28522}}, {"zip"=>"24153", "city"=>"Salem", "state"=>"Virginia", "country"=>"United States", "facility"=>"Salem Veterans Administration Med Ctr", "geoPoint"=>{"lat"=>37.29347, "lon"=>-80.05476}}, {"zip"=>"98104", "city"=>"Seattle", "state"=>"Washington", "country"=>"United States", "facility"=>"Univ of Washington", "geoPoint"=>{"lat"=>47.60621, "lon"=>-122.33207}}, {"zip"=>"53213", "city"=>"Wauwatosa", "state"=>"Wisconsin", "country"=>"United States", "facility"=>"Great Lakes Hemophilia Foundation", "geoPoint"=>{"lat"=>43.04946, "lon"=>-88.00759}}], "overallOfficials"=>[{"name"=>"Crumpacker C", "role"=>"STUDY_CHAIR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}, "collaborators"=>[{"name"=>"Bristol-Myers Squibb", "class"=>"INDUSTRY"}, {"name"=>"Glaxo Wellcome", "class"=>"INDUSTRY"}]}}}
