Nctid:
NCT00002186
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D007239", "term"=>"Infections"}, {"id"=>"D003141", "term"=>"Communicable Diseases"}, {"id"=>"D015658", "term"=>"HIV Infections"}, {"id"=>"D006561", "term"=>"Herpes Simplex"}, {"id"=>"D000163", "term"=>"Acquired Immunodeficiency Syndrome"}, {"id"=>"D007153", "term"=>"Immunologic Deficiency Syndromes"}], "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"=>"D007154", "term"=>"Immune System Diseases"}, {"id"=>"D006566", "term"=>"Herpesviridae Infections"}, {"id"=>"D004266", "term"=>"DNA Virus Infections"}, {"id"=>"D017193", "term"=>"Skin Diseases, Viral"}, {"id"=>"D012874", "term"=>"Skin Diseases, Infectious"}, {"id"=>"D012871", "term"=>"Skin Diseases"}, {"id"=>"D012897", "term"=>"Slow Virus Diseases"}], "browseLeaves"=>[{"id"=>"M14850", "name"=>"Recurrence", "relevance"=>"LOW"}, {"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M10283", "name"=>"Infections", "asFound"=>"Infection", "relevance"=>"HIGH"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "asFound"=>"Infection", "relevance"=>"HIGH"}, {"id"=>"M17522", "name"=>"Virus Diseases", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "asFound"=>"Acquired Immunodeficiency Syndrome (AIDS)", "relevance"=>"HIGH"}, {"id"=>"M9639", "name"=>"Herpes Simplex", "asFound"=>"Herpes Simplex", "relevance"=>"HIGH"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "asFound"=>"Immunodeficiency Syndrome", "relevance"=>"HIGH"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "asFound"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"HIGH"}, {"id"=>"M12825", "name"=>"Opportunistic Infections", "relevance"=>"LOW"}, {"id"=>"M19410", "name"=>"AIDS-Related Opportunistic Infections", "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"=>"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"=>"M9643", "name"=>"Herpesviridae Infections", "relevance"=>"LOW"}, {"id"=>"M7442", "name"=>"DNA Virus Infections", "relevance"=>"LOW"}, {"id"=>"M15674", "name"=>"Skin Diseases", "relevance"=>"LOW"}, {"id"=>"M19501", "name"=>"Skin Diseases, Viral", "relevance"=>"LOW"}, {"id"=>"M15677", "name"=>"Skin Diseases, Infectious", "relevance"=>"LOW"}, {"id"=>"M15700", "name"=>"Slow Virus 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"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000212", "term"=>"Acyclovir"}], "ancestors"=>[{"id"=>"D000998", "term"=>"Antiviral Agents"}, {"id"=>"D000890", "term"=>"Anti-Infective Agents"}], "browseLeaves"=>[{"id"=>"M3567", "name"=>"Acyclovir", "asFound"=>"Polysaccharide", "relevance"=>"HIGH"}, {"id"=>"M4314", "name"=>"Antiviral Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"maskingInfo"=>{"masking"=>"DOUBLE"}, "primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>400}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1998-02", "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", "Herpes Simplex", "Drug Therapy, Combination", "Acyclovir", "Antiviral Agents", "Gels", "SP 303"], "conditions"=>["Herpes Simplex", "HIV Infections"]}, "descriptionModule"=>{"briefSummary"=>"To evaluate the safety of topically applied SP-303 gel and to compare the efficacy of SP-303 gel in combination with acyclovir, relative to acyclovir alone, for the treatment of recurrent Herpes Simplex Virus (HSV) 1 and 2 infections, affecting the genital, perianal and neighboring areas, in patients with AIDS.", "detailedDescription"=>"This trial is a double-blind, multicenter, placebo-controlled clinical trial. Participants are randomized to topical 15% SP-303 gel and oral acyclovir or to matching topical placebo gel and oral acyclovir. At presentation, patients are stratified by total lesion area within each treatment group. SP-303 or matching placebo is topically applied three times a day until all lesions are reepithelialized or for 14 days, whichever occurs earlier. Acyclovir is administered by mouth each day, three times a day, until all lesions are reepithelialized or for 14 days, whichever occurs earlier. Patients are evaluated for lesion healing and adverse events 3 times per week during the treatment period. The primary efficacy endpoint will be complete lesion healing and the primary analysis will be time to complete healing."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nPatients must have:\n\n* AIDS, according to the CDC criteria.\n* Documented recurrent (at least 1 prior episode) perineal (genital, perianal and neighboring areas) mucocutaneous herpes simplex virus (HSV) types 1 or 2 infection in the active phase.\n* Duration of current episode of recurrent HSV lesions of 3 days or less.\n* Ability to read and write, must be intellectually competent, and able to understand the purposes and risks of the study.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms and conditions are excluded:\n\n* Active internal anal or rectal herpes.\n* Inability to comply with protocol.\n* Impaired renal function.\n\nPatients with the following prior conditions are excluded:\n\n* Prior episode of recurrent genital herpes infection with documented clinical failure of acyclovir as a treatment regimen.\n* Uncompensated hepatic, cardiac, or renal failure within 1 month of the study.\n* History of hypersensitivity to acyclovir.\n* Previous enrollment in this study.\n\n 1. Treatment with another medication (topical, oral, or intravenous) with known anti-HSV activity within the past 5 days.\n* Systemic immunomodulatory therapy within 30 days prior to study.\n* Previous treatment with SP-303.\n\nRequired:\n\nUnchanged antiretroviral therapy for the 2 weeks prior to study."}, "identificationModule"=>{"nctId"=>"NCT00002186", "briefTitle"=>"Double-Blind Placebo-Controlled Study Comparing the Combination of 15% SP-303 Gel With Acyclovir Versus Acyclovir Alone for the Treatment of Recurrent Herpes Simplex Virus (HSV) Infections in Subjects With Acquired Immunodeficiency Syndrome (AIDS)", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"NIH AIDS Clinical Trials Information Service"}, "officialTitle"=>"Double-Blind Placebo-Controlled Study Comparing the Combination of 15% SP-303 Gel With Acyclovir Versus Acyclovir Alone for the Treatment of Recurrent Herpes Simplex Virus (HSV) Infections in Subjects With Acquired Immunodeficiency Syndrome (AIDS)", "orgStudyIdInfo"=>{"id"=>"270A"}, "secondaryIdInfos"=>[{"id"=>"96-867-DE"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Crofelemer", "type"=>"DRUG"}, {"name"=>"Acyclovir", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"35203", "city"=>"Birmingham", "state"=>"Alabama", "country"=>"United States", "facility"=>"Sorra Research Ctr Inc / Med Forum", "geoPoint"=>{"lat"=>33.52066, "lon"=>-86.80249}}, {"zip"=>"85251", "city"=>"Scottsdale", "state"=>"Arizona", "country"=>"United States", "facility"=>"Hill Top Research Ltd", "geoPoint"=>{"lat"=>33.50921, "lon"=>-111.89903}}, {"zip"=>"85712", "city"=>"Tucson", "state"=>"Arizona", "country"=>"United States", "facility"=>"Arizona Clinical Research Ctr Inc", "geoPoint"=>{"lat"=>32.22174, "lon"=>-110.92648}}, {"zip"=>"90822", "city"=>"Long Beach", "state"=>"California", "country"=>"United States", "facility"=>"Dermatology SVC - VAMC", "geoPoint"=>{"lat"=>33.76696, "lon"=>-118.18923}}, {"zip"=>"90059", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"King - Drew Med Ctr / Dept of Dermatology", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"94609", "city"=>"Oakland", "state"=>"California", "country"=>"United States", "facility"=>"Summit Med Ctr / Adult Immunology Clinic", "geoPoint"=>{"lat"=>37.80437, "lon"=>-122.2708}}, {"zip"=>"92262", "city"=>"Palm Springs", "state"=>"California", "country"=>"United States", "facility"=>"ViRx Inc", "geoPoint"=>{"lat"=>33.8303, "lon"=>-116.54529}}, {"zip"=>"94109", "city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"ViRx Inc", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"94117", "city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"Conant Med Ctr", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"91342", "city"=>"Sylmar", "state"=>"California", "country"=>"United States", "facility"=>"Olive View Med Ctr", "geoPoint"=>{"lat"=>34.30778, "lon"=>-118.44925}}, {"zip"=>"20037", "city"=>"Washington", "state"=>"District of Columbia", "country"=>"United States", "facility"=>"Novum Inc", "geoPoint"=>{"lat"=>38.89511, "lon"=>-77.03637}}, {"zip"=>"32701", "city"=>"Altamonte Springs", "state"=>"Florida", "country"=>"United States", "facility"=>"IDC Research Initiative", "geoPoint"=>{"lat"=>28.66111, "lon"=>-81.36562}}, {"zip"=>"33316", "city"=>"Fort Lauderdale", "state"=>"Florida", "country"=>"United States", "facility"=>"Gary Richmond MD", "geoPoint"=>{"lat"=>26.12231, "lon"=>-80.14338}}, {"zip"=>"33901", "city"=>"Fort Myers", "state"=>"Florida", "country"=>"United States", "facility"=>"Dr Robert Schwartz", "geoPoint"=>{"lat"=>26.62168, "lon"=>-81.84059}}, {"zip"=>"33614", "city"=>"Tampa", "state"=>"Florida", "country"=>"United States", "facility"=>"Infectious Disease Research Institute Inc", "geoPoint"=>{"lat"=>27.94752, "lon"=>-82.45843}}, {"zip"=>"32960", "city"=>"Vero Beach", "state"=>"Florida", "country"=>"United States", "facility"=>"Treasure Coast Infectious Disease Consultants", "geoPoint"=>{"lat"=>27.63864, "lon"=>-80.39727}}, {"zip"=>"60064", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Veterans Affairs Med Ctr of North Chicago", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"21205", "city"=>"Baltimore", "state"=>"Maryland", "country"=>"United States", "facility"=>"Johns Hopkins Univ / Division of Infectious Disease", "geoPoint"=>{"lat"=>39.29038, "lon"=>-76.61219}}, {"zip"=>"21229", "city"=>"Baltimore", "state"=>"Maryland", "country"=>"United States", "facility"=>"Saint Agnes Healthcare / Dept of Surgery", "geoPoint"=>{"lat"=>39.29038, "lon"=>-76.61219}}, {"zip"=>"02114", "city"=>"Boston", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Massachusetts Gen Hosp - Warren 505", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}, {"zip"=>"55455", "city"=>"Minneapolis", "state"=>"Minnesota", "country"=>"United States", "facility"=>"Medicine / Infectious Diseases", "geoPoint"=>{"lat"=>44.97997, "lon"=>-93.26384}}, {"zip"=>"10011", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"AIDS Ctr / Saint Vincents Hosp and Med Ctr", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"10016", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"New York Univ Med 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"=>"10032", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Columbia Presbyterian Med Ctr", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"19103", "city"=>"Philadelphia", "state"=>"Pennsylvania", "country"=>"United States", "facility"=>"Paddington Testing Co Inc", "geoPoint"=>{"lat"=>39.95233, "lon"=>-75.16379}}, {"zip"=>"78705", "city"=>"Austin", "state"=>"Texas", "country"=>"United States", "facility"=>"Austin Infectious Disease Consultants", "geoPoint"=>{"lat"=>30.26715, "lon"=>-97.74306}}, {"zip"=>"75219", "city"=>"Dallas", "state"=>"Texas", "country"=>"United States", "facility"=>"N Texas Ctr for AIDS & Clin Rsch", "geoPoint"=>{"lat"=>32.78306, "lon"=>-96.80667}}, {"zip"=>"77030", "city"=>"Houston", "state"=>"Texas", "country"=>"United States", "facility"=>"Division of Infectious Diseases / Univ of Texas - Houston", "geoPoint"=>{"lat"=>29.76328, "lon"=>-95.36327}}, {"zip"=>"22205", "city"=>"Arlington", "state"=>"Virginia", "country"=>"United States", "facility"=>"Dr Robert Holman", "geoPoint"=>{"lat"=>38.88101, "lon"=>-77.10428}}, {"zip"=>"98122", "city"=>"Seattle", "state"=>"Washington", "country"=>"United States", "facility"=>"Novum Inc", "geoPoint"=>{"lat"=>47.60621, "lon"=>-122.33207}}, {"zip"=>"98122", "city"=>"Seattle", "state"=>"Washington", "country"=>"United States", "facility"=>"Univ of Washington Virology Research Clinic", "geoPoint"=>{"lat"=>47.60621, "lon"=>-122.33207}}, {"zip"=>"00731", "city"=>"Ponce", "country"=>"Puerto Rico", "facility"=>"Hosp Regional de Ponce - Area Vieja", "geoPoint"=>{"lat"=>18.01108, "lon"=>-66.61406}}, {"zip"=>"00908", "city"=>"Santurce", "country"=>"Puerto Rico", "facility"=>"San Juan AIDS Program", "geoPoint"=>{"lat"=>18.19523, "lon"=>-67.14018}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Shaman Pharmaceuticals", "class"=>"INDUSTRY"}}}}
