Nctid:
NCT00000806
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-09-05"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000015658", "term"=>"HIV Infections"}], "ancestors"=>[{"id"=>"D000086982", "term"=>"Blood-Borne Infections"}, {"id"=>"D000003141", "term"=>"Communicable Diseases"}, {"id"=>"D000007239", "term"=>"Infections"}, {"id"=>"D000015229", "term"=>"Sexually Transmitted Diseases, Viral"}, {"id"=>"D000012749", "term"=>"Sexually Transmitted Diseases"}, {"id"=>"D000016180", "term"=>"Lentivirus Infections"}, {"id"=>"D000012192", "term"=>"Retroviridae Infections"}, {"id"=>"D000012327", "term"=>"RNA Virus Infections"}, {"id"=>"D000014777", "term"=>"Virus Diseases"}, {"id"=>"D000091662", "term"=>"Genital Diseases"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}, {"id"=>"D000007153", "term"=>"Immunologic Deficiency Syndromes"}, {"id"=>"D000007154", "term"=>"Immune System 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", "asFound"=>"HIV Infections", "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"=>"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"}], "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"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M19609", "name"=>"HIV Protease Inhibitors", "relevance"=>"LOW"}, {"id"=>"M14343", "name"=>"Protease Inhibitors", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>48}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1995-02", "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"=>["Acquired Immunodeficiency Syndrome", "AIDS-Related Complex", "HIV Protease Inhibitors"], "conditions"=>["HIV Infections"]}, "referencesModule"=>{"references"=>[{"type"=>"BACKGROUND", "citation"=>"Fischl MA, Richman DD, Flexner C, Meehan P, Para MF, Haubrich R, Cook J, Wood K, Karim A. Phase I study of two formulations and dose schedules of SC- 521151, A protease inhibitor. Natl Conf Hum Retroviruses Relat Infect (2nd). 1995 Jan 29-Feb 2:88"}]}, "descriptionModule"=>{"briefSummary"=>"PRIMARY: To evaluate the safety, tolerability, pharmacokinetics, and ethanol exposure of two dose regimens and formulations of SC-52151.\n\nSECONDARY: To evaluate the preliminary anti-HIV activity of these treatment regimens and the relationship between day 14 plasma concentrations of SC-52151 and immunological and virological markers and toxicity.\n\nSince viral isolates with decreased susceptibility to the protease inhibitor SC-52151 occur in vitro after multiple passages, and since prolonged post infectious effects occur in vitro, comparison of two formulations, an elixir and a self-emulsifying drug delivery system (SEDDS), is needed to determine the appropriate dose formulation for Phase II studies.", "detailedDescription"=>"Since viral isolates with decreased susceptibility to the protease inhibitor SC-52151 occur in vitro after multiple passages, and since prolonged post infectious effects occur in vitro, comparison of two formulations, an elixir and a self-emulsifying drug delivery system (SEDDS), is needed to determine the appropriate dose formulation for Phase II studies.\n\nPatients are randomized to four treatment arms to receive SC-52151 elixir or SEDDS formulation at 1 of 2 doses for 2 weeks, with follow-up for 14 days."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"21 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nRequired for patients with CD4 count \\<= 200 cells/mm3:\n\n* PCP prophylaxis using TMP/SMX or aerosolized pentamidine.\n\nAllowed:\n\n* Topical antifungal agents.\n* Up to 1000 mg/day acyclovir as maintenance therapy for herpes simplex virus.\n* Antibiotics for bacterial infections.\n* Antipyretics, analgesics, nonsteroidal anti-inflammatory agents, antiemetics, and methadone for symptomatic treatment.\n\nPatients must have:\n\n* HIV infection.\n* CD4 count 150 - 500 cells/mm3.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\n* Unable to tolerate the standard diet required for the study.\n* Unable to give informed consent.\n\nConcurrent Medication:\n\nExcluded:\n\n* Antiretrovirals and biologic response modifiers (including HIV vaccines).\n* Maintenance with ketoconazole, fluconazole, itraconazole, ganciclovir, foscarnet, pyrimethamine, sulfadiazine, clindamycin, azithromycin, isoniazid, rifampin, rifabutin, ethambutol, pyrazinamide, clofazimine, or clarithromycin.\n* Prophylaxis for Mycobacterial infection or fungal infections other than Candidiasis.\n* Allopurinol.\n* Omeprazole.\n* Astemizole.\n* Terfenadine.\n* Loratadine.\n* Psychotropics.\n* Phenylbutazone.\n* Barbiturates.\n* Benzodiazepines.\n* Monoamine oxidase inhibitors.\n* H-2 blockers.\n* Anticonvulsants.\n* Coumadin anticoagulants.\n* Oral contraceptives.\n* Antiarrhythmics.\n* Diltiazem.\n* Metronidazole.\n* Erythromycin.\n* Chloramphenicol.\n* Fluoroquinolones.\n* Disulfiram.\n* Erythropoietin.\n* G-CSF or GM-CSF.\n* Systemic corticosteroids.\n* Alcohol, including alcohol-containing medications.\n\nPatients with the following prior conditions are excluded:\n\n* Unexplained temperature \\>= 38.5 C for any 7 days within the 30 days prior to study entry.\n* Chronic diarrhea (\\>= three stools per day) for any 15 days within the 30 days prior to study entry.\n* Malignancy other than basal or squamous cell carcinoma of the skin, cervical intraepithelial neoplasia, and minimal Kaposi's sarcoma.\n\nPrior Medication:\n\nExcluded at any time:\n\n* Prior HIV protease inhibitor.\n\nExcluded within 30 days prior to study entry:\n\n* Investigational drugs.\n* Recombinant erythropoietin.\n* G-CSF or GM-CSF.\n* Interferon or interleukin.\n* Any HIV-1 vaccine.\n\nExcluded within 14 days prior to study entry:\n\n* Antiretrovirals.\n* Acute therapy for any opportunistic or other serious infection.\n* Therapy for malignancy.\n* Maintenance with ketoconazole, fluconazole, itraconazole, ganciclovir, foscarnet, pyrimethamine, sulfadiazine, clindamycin, azithromycin, isoniazid, rifampin, rifabutin, ethambutol, pyrazinamide, clofazimine, or clarithromycin.\n* Prophylaxis for Mycobacterial infection or fungal infections other than Candidiasis.\n\nExcluded within 7 days prior to study entry:\n\n* Allopurinol.\n* Omeprazole.\n* Astemizole.\n* Terfenadine.\n* Loratadine.\n* Psychotropics.\n* Phenylbutazone.\n* Barbiturates.\n* Benzodiazepines.\n* Monoamine oxidase inhibitors.\n* H-2 blockers.\n* Anticonvulsants.\n* Coumadin anticoagulants.\n* Oral contraceptives.\n* Antiarrhythmics.\n* Diltiazem.\n* Metronidazole.\n* Erythromycin.\n* Chloramphenicol.\n* Fluoroquinolones.\n* Disulfiram.\n\nRisk Behavior: Excluded:\n\n* History of substance or alcohol abuse.\n* Ingestion of more than 50 g alcohol daily within 6 months prior to study entry.\n* Recovered alcoholic."}, "identificationModule"=>{"nctId"=>"NCT00000806", "briefTitle"=>"A Phase I Randomized Dose/Formulation Comparison Study of SC-52151", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "officialTitle"=>"A Phase I Randomized Dose/Formulation Comparison Study of SC-52151", "orgStudyIdInfo"=>{"id"=>"ACTG 282"}}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Telinavir", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"921036325", "city"=>"San Diego", "state"=>"California", "country"=>"United States", "facility"=>"Univ of California / San Diego Treatment Ctr", "geoPoint"=>{"lat"=>32.71533, "lon"=>-117.15726}}, {"zip"=>"331361013", "city"=>"Miami", "state"=>"Florida", "country"=>"United States", "facility"=>"Univ of Miami School of Medicine", "geoPoint"=>{"lat"=>25.77427, "lon"=>-80.19366}}, {"zip"=>"21287", "city"=>"Baltimore", "state"=>"Maryland", "country"=>"United States", "facility"=>"Johns Hopkins Hosp", "geoPoint"=>{"lat"=>39.29038, "lon"=>-76.61219}}, {"zip"=>"432101228", "city"=>"Columbus", "state"=>"Ohio", "country"=>"United States", "facility"=>"Ohio State Univ Hosp Clinic", "geoPoint"=>{"lat"=>39.96118, "lon"=>-82.99879}}], "overallOfficials"=>[{"name"=>"Fischl MA", "role"=>"STUDY_CHAIR"}, {"name"=>"Richman DD", "role"=>"STUDY_CHAIR"}, {"name"=>"Flexner C", "role"=>"STUDY_CHAIR"}, {"name"=>"Para MF", "role"=>"STUDY_CHAIR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}}}}