Nctid:
NCT00000964
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"=>"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"=>{"meshes"=>[{"id"=>"D000017245", "term"=>"Foscarnet"}, {"id"=>"D000010746", "term"=>"Phosphonoacetic Acid"}, {"id"=>"D000011899", "term"=>"Ranitidine"}, {"id"=>"C000073340", "term"=>"Ranitidine bismuth citrate"}], "ancestors"=>[{"id"=>"D000000897", "term"=>"Anti-Ulcer Agents"}, {"id"=>"D000005765", "term"=>"Gastrointestinal Agents"}, {"id"=>"D000006635", "term"=>"Histamine H2 Antagonists"}, {"id"=>"D000006633", "term"=>"Histamine Antagonists"}, {"id"=>"D000018494", "term"=>"Histamine Agents"}, {"id"=>"D000018377", "term"=>"Neurotransmitter Agents"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000000998", "term"=>"Antiviral Agents"}, {"id"=>"D000000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D000018894", "term"=>"Reverse Transcriptase Inhibitors"}, {"id"=>"D000019384", "term"=>"Nucleic Acid Synthesis Inhibitors"}, {"id"=>"D000004791", "term"=>"Enzyme Inhibitors"}], "browseLeaves"=>[{"id"=>"M14745", "name"=>"Ranitidine", "asFound"=>"Pineal", "relevance"=>"HIGH"}, {"id"=>"M252088", "name"=>"Ranitidine bismuth citrate", "asFound"=>"Pineal", "relevance"=>"HIGH"}, {"id"=>"M19543", "name"=>"Foscarnet", "asFound"=>"Polyurethane", "relevance"=>"HIGH"}, {"id"=>"M13647", "name"=>"Phosphonoacetic Acid", "asFound"=>"Gefapixant", "relevance"=>"HIGH"}, {"id"=>"M21320", "name"=>"Citric Acid", "relevance"=>"LOW"}, {"id"=>"M1837", "name"=>"Sodium Citrate", "relevance"=>"LOW"}, {"id"=>"M5011", "name"=>"Bismuth", "relevance"=>"LOW"}, {"id"=>"M226511", "name"=>"Bismuth tripotassium dicitrate", "relevance"=>"LOW"}, {"id"=>"M4188", "name"=>"Antacids", "relevance"=>"LOW"}, {"id"=>"M4219", "name"=>"Anti-Ulcer Agents", "relevance"=>"LOW"}, {"id"=>"M8881", "name"=>"Gastrointestinal Agents", "relevance"=>"LOW"}, {"id"=>"M9708", "name"=>"Histamine", "relevance"=>"LOW"}, {"id"=>"M9711", "name"=>"Histamine H2 Antagonists", "relevance"=>"LOW"}, {"id"=>"M212144", "name"=>"Histamine phosphate", "relevance"=>"LOW"}, {"id"=>"M9709", "name"=>"Histamine Antagonists", "relevance"=>"LOW"}, {"id"=>"M20504", "name"=>"Neurotransmitter Agents", "relevance"=>"LOW"}, {"id"=>"M4314", "name"=>"Antiviral Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M20935", "name"=>"Reverse Transcriptase Inhibitors", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"T382", "name"=>"Citrate", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Gastrointestinal Agents", "abbrev"=>"Gast"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"Anticoagulants", "abbrev"=>"AnCoag"}, {"name"=>"Other Dietary Supplements", "abbrev"=>"Ot"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>6}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2021-10", "completionDateStruct"=>{"date"=>"1990-10", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2021-10-28", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2021-10-29", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Ranitidine", "Phosphorus Acids", "Drug Evaluation", "Acquired Immunodeficiency Syndrome"], "conditions"=>["HIV Infections"]}, "referencesModule"=>{"references"=>[{"pmid"=>"9754889", "type"=>"BACKGROUND", "citation"=>"Barditch-Crovo PA, Petty BG, Gambertoglio J, Nerhood LJ, Kuwahara S, Hafner R, Lietman PS, Kornhauser DM. The effect of increasing gastric pH upon the bioavailability of orally-administered foscarnet. Antiviral Res. 1998 Jun;38(3):209-12. doi: 10.1016/s0166-3542(98)00024-2."}]}, "descriptionModule"=>{"briefSummary"=>"To see if ranitidine, by reducing stomach acidity, can enhance the effectiveness of foscarnet, by making foscarnet more available to the body.\n\nFoscarnet is an antiviral compound. Laboratory studies have shown it to be active against HIV. However, only 12 - 22 percent of an oral foscarnet dose is absorbed by the body. Ranitidine suppresses gastric acid output, increasing gastric pH. Thus by increasing gastric pH (decreasing stomach acidity), less foscarnet is expected to be decomposed or broken down in the stomach. Thus, more foscarnet should be absorbed into the body.", "detailedDescription"=>"Foscarnet is an antiviral compound. Laboratory studies have shown it to be active against HIV. However, only 12 - 22 percent of an oral foscarnet dose is absorbed by the body. Ranitidine suppresses gastric acid output, increasing gastric pH. Thus by increasing gastric pH (decreasing stomach acidity), less foscarnet is expected to be decomposed or broken down in the stomach. Thus, more foscarnet should be absorbed into the body.\n\nSix asymptomatic HIV-infected males, or those with limited symptoms of early AIDS-related complex ( ARC ), will receive one dose intravenously of ranitidine in distilled water and one dose of placebo (distilled water alone), followed in 1 hour by foscarnet in oral solution. The order of ranitidine and placebo is randomized and the two foscarnet doses are separated by at least 72 hours. A nasogastric pH probe is placed on each morning of drug administration to monitor gastric pH."}, "eligibilityModule"=>{"sex"=>"MALE", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Acetaminophen and sedatives.\n\nPatient must be able to give informed consent.\n\nExclusion Criteria\n\nPatients with the following are excluded:\n\n* Unintentional weight loss in excess of 10 pounds or 10 percent of usual body weight within 2 years prior to study.\n* Unexplained temperature above 38 degrees Celsius on more than 5 consecutive days or on more than 10 days in any 30 days in 2 years prior to expected study entry.\n* Unexplained diarrhea defined by two or more stools/day for at least 14 days during a 120-day interval.\n\nPrior Medication:\n\nExcluded within 1 week of entry into study:\n\n* Probenecid, aspirin, or diuretics."}, "identificationModule"=>{"nctId"=>"NCT00000964", "briefTitle"=>"The Effect of Stomach Acid on Foscarnet", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "officialTitle"=>"The Effect of Increasing Gastric pH Upon the Bioavailability of Orally Administered Phosphonoformic Acid (Foscarnet)", "orgStudyIdInfo"=>{"id"=>"ACTG 136"}, "secondaryIdInfos"=>[{"id"=>"11111", "type"=>"REGISTRY", "domain"=>"DAIDS ES Registry Number"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Ranitidine hydrochloride", "type"=>"DRUG"}, {"name"=>"Foscarnet sodium", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"21205", "city"=>"Baltimore", "state"=>"Maryland", "country"=>"United States", "facility"=>"Johns Hopkins Adult AIDS CRS", "geoPoint"=>{"lat"=>39.29038, "lon"=>-76.61219}}], "overallOfficials"=>[{"name"=>"DM Kornhauser", "role"=>"STUDY_CHAIR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
