Nctid:
NCT00002327
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D007239", "term"=>"Infections"}, {"id"=>"D015658", "term"=>"HIV Infections"}, {"id"=>"D000163", "term"=>"Acquired Immunodeficiency Syndrome"}], "ancestors"=>[{"id"=>"D003141", "term"=>"Communicable Diseases"}, {"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", "relevance"=>"LOW"}, {"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"=>"M17603", "name"=>"Warts", "relevance"=>"LOW"}, {"id"=>"M6443", "name"=>"Condylomata Acuminata", "relevance"=>"LOW"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M12825", "name"=>"Opportunistic Infections", "relevance"=>"LOW"}, {"id"=>"M19410", "name"=>"AIDS-Related Opportunistic Infections", "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"}, {"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"}, {"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000077404", "term"=>"Cidofovir"}], "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"=>"M4314", "name"=>"Antiviral Agents", "relevance"=>"LOW"}, {"id"=>"M1785", "name"=>"Cidofovir", "asFound"=>"AZD6244", "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"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>40}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1997-08", "lastUpdateSubmitDate"=>"2005-06-23", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2005-06-24", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["AIDS-Related Opportunistic Infections", "Acquired Immunodeficiency Syndrome", "AIDS-Related Complex", "Antiviral Agents", "Condylomata Acuminata", "cidofovir"], "conditions"=>["HIV Infections", "Condyloma Acuminata"]}, "referencesModule"=>{"references"=>[{"type"=>"BACKGROUND", "citation"=>"Douglas J, Corey L, Tyring S, Kriesel J, Bowden B, Crosby D, Berger T, Conant M, McGuire B, Jaffe HS. A phase I/II study of cidofovir topical gel for refractory condyloma acuminatum in patients with HIV infection. Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:126 (abstract no 334)"}]}, "descriptionModule"=>{"briefSummary"=>"To evaluate the safety and tolerance of topical cidofovir (HPMPC) therapy for condyloma acuminatum in patients with HIV infection. To investigate whether topical HPMPC therapy can induce regression of condyloma acuminatum in patients with HIV infection.", "detailedDescription"=>"Four groups of 10 patients each receive topical HPMPC at 0.3 percent concentration for 5 or 10 days total or 1.0 percent concentration for 5 or 10 days total, followed by 2 weeks of rest. When six patients at a given dose and schedule have completed treatment and follow-up without significant toxicity, subsequent patients are entered at the next higher dose level. Patients are evaluated twice weekly during treatment and once weekly during the rest period. HPMPC may be extended for up to two additional courses in patients who experience no significant toxicity."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* AZT, ddI, ddC, d4T, or 3TC.\n* Oral trimethoprim/sulfamethoxazole.\n* Aerosolized pentamidine.\n* Dapsone.\n* Fluconazole.\n* Rifabutin.\n* Clarithromycin.\n\nPatients must have:\n\n* HIV seropositivity.\n* Mean CD4 count \\>= 100 cells/mm3.\n* External anogenital condyloma acuminatum confirmed by biopsy, present for less than 1 year. NOTE:\n* Warts on anal, urethral, or vaginal mucosa will not be studied.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\n* Active lesions of genital herpes, other skin wounds, or active inflammatory skin disorders in the same area as warts to be treated.\n* Active medical problems sufficient to hinder study compliance.\n\nConcurrent Medication:\n\nExcluded:\n\n* Podofilox or any podophyllum resin preparation.\n* Liquid nitrogen treatment.\n* Interferon alpha.\n* Trichloracetic acid.\n* Other treatments, topical or systemic, surgical or ablative, known to have anti-papilloma activity.\n* Other investigative drugs (except d4T or 3TC) unless approved by the sponsor.\n\nPatients with the following prior conditions are excluded:\n\nHistory of untreated syphilis or Bowenoid papulosis.\n\nPrior Medication:\n\nExcluded within 4 weeks prior to study entry:\n\n* Treatment for anogenital warts.\n* Immunomodulators (including interferons or systemic corticosteroids).\n* Lymphocyte replacement therapy.\n* Biologic response modifiers. Substance abuse."}, "identificationModule"=>{"nctId"=>"NCT00002327", "briefTitle"=>"The Safety and Effectiveness of Cidofovir in the Treatment of Venereal Warts in HIV-Infected Patients", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"NIH AIDS Clinical Trials Information Service"}, "officialTitle"=>"A Phase I/II Study of the Safety and Efficacy of Topical 1-(S)-(3-Hydroxy-2-Phosphonylmethoxypropyl)Cytosine Dihydrate (Cidofovir; HPMPC) in the Treatment of Condyloma Acuminatum in Patients With HIV Infection", "orgStudyIdInfo"=>{"id"=>"219A"}, "secondaryIdInfos"=>[{"id"=>"GS-93-302"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Cidofovir", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"94705", "city"=>"Berkeley", "state"=>"California", "country"=>"United States", "facility"=>"East Bay AIDS Ctr", "geoPoint"=>{"lat"=>37.87159, "lon"=>-122.27275}}, {"zip"=>"941430316", "city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"Univ California San Francisco", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"802044507", "city"=>"Denver", "state"=>"Colorado", "country"=>"United States", "facility"=>"City and County of Denver / Dept of Health & Hosps", "geoPoint"=>{"lat"=>39.73915, "lon"=>-104.9847}}, {"zip"=>"10453", "city"=>"Bronx", "state"=>"New York", "country"=>"United States", "facility"=>"Bronx-Lebanon Hosp Ctr", "geoPoint"=>{"lat"=>40.84985, "lon"=>-73.86641}}, {"zip"=>"14642", "city"=>"Rochester", "state"=>"New York", "country"=>"United States", "facility"=>"Univ of Rochester Med Ctr", "geoPoint"=>{"lat"=>43.15478, "lon"=>-77.61556}}, {"zip"=>"77006", "city"=>"Houston", "state"=>"Texas", "country"=>"United States", "facility"=>"Houston Clinical Research Network", "geoPoint"=>{"lat"=>29.76328, "lon"=>-95.36327}}, {"zip"=>"77027", "city"=>"Houston", "state"=>"Texas", "country"=>"United States", "facility"=>"Dr Brad Bowden", "geoPoint"=>{"lat"=>29.76328, "lon"=>-95.36327}}, {"zip"=>"77058", "city"=>"Nassau Bay", "state"=>"Texas", "country"=>"United States", "facility"=>"Dr Stephen Tyring", "geoPoint"=>{"lat"=>29.54468, "lon"=>-95.09104}}, {"zip"=>"84132", "city"=>"Salt Lake City", "state"=>"Utah", "country"=>"United States", "facility"=>"Univ of Utah School of Medicine", "geoPoint"=>{"lat"=>40.76078, "lon"=>-111.89105}}, {"zip"=>"98122", "city"=>"Seattle", "state"=>"Washington", "country"=>"United States", "facility"=>"Univ of Washington / Viral Disease Clinic", "geoPoint"=>{"lat"=>47.60621, "lon"=>-122.33207}}, {"zip"=>"98144", "city"=>"Seattle", "state"=>"Washington", "country"=>"United States", "facility"=>"Pacific Med Ctr", "geoPoint"=>{"lat"=>47.60621, "lon"=>-122.33207}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Gilead Sciences", "class"=>"INDUSTRY"}}}}
