Nctid:
NCT00002300
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-27"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D019282", "term"=>"Wasting Syndrome"}, {"id"=>"D000855", "term"=>"Anorexia"}, {"id"=>"D002100", "term"=>"Cachexia"}], "ancestors"=>[{"id"=>"D012817", "term"=>"Signs and Symptoms, Digestive"}, {"id"=>"D015431", "term"=>"Weight Loss"}, {"id"=>"D001836", "term"=>"Body Weight Changes"}, {"id"=>"D001835", "term"=>"Body Weight"}, {"id"=>"D013851", "term"=>"Thinness"}, {"id"=>"D008659", "term"=>"Metabolic Diseases"}, {"id"=>"D009748", "term"=>"Nutrition Disorders"}], "browseLeaves"=>[{"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M25306", "name"=>"Malnutrition", "relevance"=>"LOW"}, {"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M4181", "name"=>"Anorexia", "asFound"=>"Anorexia", "relevance"=>"HIGH"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M21265", "name"=>"Wasting Syndrome", "asFound"=>"Cachexia", "relevance"=>"HIGH"}, {"id"=>"M5363", "name"=>"Cachexia", "asFound"=>"Cachexia", "relevance"=>"HIGH"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M15622", "name"=>"Signs and Symptoms, Digestive", "relevance"=>"LOW"}, {"id"=>"M18102", "name"=>"Weight Loss", "relevance"=>"LOW"}, {"id"=>"M5114", "name"=>"Body Weight", "relevance"=>"LOW"}, {"id"=>"M5115", "name"=>"Body Weight Changes", "relevance"=>"LOW"}, {"id"=>"M16614", "name"=>"Thinness", "relevance"=>"LOW"}, {"id"=>"M11639", "name"=>"Metabolic Diseases", "relevance"=>"LOW"}, {"id"=>"M12684", "name"=>"Nutrition Disorders", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Nutritional and Metabolic Diseases", "abbrev"=>"BC18"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D008535", "term"=>"Megestrol"}, {"id"=>"D019290", "term"=>"Megestrol Acetate"}], "ancestors"=>[{"id"=>"D003278", "term"=>"Contraceptives, Oral, Hormonal"}, {"id"=>"D003276", "term"=>"Contraceptives, Oral"}, {"id"=>"D003271", "term"=>"Contraceptive Agents, Female"}, {"id"=>"D003270", "term"=>"Contraceptive Agents"}, {"id"=>"D012102", "term"=>"Reproductive Control Agents"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000080066", "term"=>"Contraceptive Agents, Hormonal"}, {"id"=>"D003280", "term"=>"Contraceptives, Oral, Synthetic"}, {"id"=>"D018931", "term"=>"Antineoplastic Agents, Hormonal"}, {"id"=>"D000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D019167", "term"=>"Appetite Stimulants"}, {"id"=>"D000697", "term"=>"Central Nervous System Stimulants"}], "browseLeaves"=>[{"id"=>"M11518", "name"=>"Megestrol", "asFound"=>"PD-1 inhibitor", "relevance"=>"HIGH"}, {"id"=>"M21272", "name"=>"Megestrol Acetate", "asFound"=>"Aphasia", "relevance"=>"HIGH"}, {"id"=>"M6494", "name"=>"Contraceptive Agents", "relevance"=>"LOW"}, {"id"=>"M6500", "name"=>"Contraceptives, Oral", "relevance"=>"LOW"}, {"id"=>"M6502", "name"=>"Contraceptives, Oral, Hormonal", "relevance"=>"LOW"}, {"id"=>"M6495", "name"=>"Contraceptive Agents, Female", "relevance"=>"LOW"}, {"id"=>"M2116", "name"=>"Contraceptive Agents, Hormonal", "relevance"=>"LOW"}, {"id"=>"M20966", "name"=>"Antineoplastic Agents, Hormonal", "relevance"=>"LOW"}, {"id"=>"M4029", "name"=>"Central Nervous System Stimulants", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"Reproductive Control Agents", "abbrev"=>"Repr"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Central Nervous System Stimulants", "abbrev"=>"CNSSti"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"maskingInfo"=>{"masking"=>"DOUBLE"}, "primaryPurpose"=>"TREATMENT"}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "statusVerifiedDate"=>"2007-10", "lastUpdateSubmitDate"=>"2007-10-01", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2007-10-02", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["T-Lymphocytes", "Megestrol", "Dose-Response Relationship, Drug", "Acquired Immunodeficiency Syndrome", "Anorexia", "Cachexia"], "conditions"=>["Anorexia", "Cachexia", "HIV Infections"]}, "referencesModule"=>{"references"=>[{"pmid"=>"9066597", "type"=>"BACKGROUND", "citation"=>"Strang P. The effect of megestrol acetate on anorexia, weight loss and cachexia in cancer and AIDS patients (review). Anticancer Res. 1997 Jan-Feb;17(1B):657-62."}]}, "descriptionModule"=>{"briefSummary"=>"To compare the effects of megestrol acetate and placebo on body weight, anorexia, cachexia, calorie intake, and nutritional parameters of patients with a confirmed diagnosis of AIDS. To characterize dose response in relation to weight gain. To determine whether megestrol acetate relative to placebo improves the perception of well-being among AIDS patients with cachexia. To evaluate megestrol acetate's effect on immune function via skin test reactivity, T4/T8 ratio, and total lymphocytes."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nPatient must have:\n\n* Confirmed diagnosis of AIDS (CDC definition).\n* Documented weight loss or anorexia.\n* Life expectancy = or \\> 20 weeks.\n* The perception that the weight loss is a detriment to their well-being.\n* Ability to provide informed consent, read and write English.\n\nPrior Medication:\n\nAllowed:\n\n* Ganciclovir.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following are excluded:\n\n* Dementia or evidence of mental incompetence which would preclude compliance with the protocol.\n* Diarrhea defined as 5 or more watery stools per day for at least 7 days.\n* Active uncontrolled systemic infections at the start of treatment.\n* (Patients may not be entered for at least 2 weeks after acute infection.) Clinical or radiologic evidence of ascites or pleural effusions.\n\nConcurrent Medication:\n\nExcluded:\n\n* Therapy designed to treat the underlying HIV infection or which may have a major impact on appetite and/or weight gain.\n* Patients who have been started on zidovudine (AZT) within eight weeks. (Patients may have been previously treated with AZT and failed or may currently be receiving AZT for at least 8 weeks.)\n\nPatients with the following are excluded:\n\n* Obstruction to food intake or impaired digestive/absorptive functions.\n* Contraindications to high-dose megestrol acetate (poorly controlled hypertension or heart failure or deep vein thrombosis).\n* Inability to consent or be available for close follow-up.\n* Active systemic infections at the start of treatment.\n* Patients may not be started on any therapy designed to treat the underlying HIV infection or which may have a major impact on appetite and/or weight gain.\n* Clinical or radiologic evidence of ascites or pleural effusions.\n* Patients may not be started on any therapy designed to treat the underlying HIV infection or which may have a major impact on appetite and/or weight gain.\n* Patients who have been hospitalized or have suffered an exacerbation of their illness associated with weight loss within the past 2 weeks are excluded.\n* Menstruating female patients are excluded.\n\nPrior Medication:\n\nExcluded:\n\n* Corticosteroids.\n* Anabolic steroids.\n* Marijuana.\n* Megestrol acetate.\n* Patients who have been started on zidovudine (AZT) within 8 weeks. (Patients may have been previously treated with AZT and failed or may currently be receiving AZT for at least 8 weeks.) History of substance abuse and questionable current and future abstinence."}, "identificationModule"=>{"nctId"=>"NCT00002300", "briefTitle"=>"A Study of Different Doses of Megestrol Acetate in Patients With AIDS Who Have Anorexia and Malnutrition", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"Bristol-Myers Squibb"}, "officialTitle"=>"Phase II-III Randomized Double-Blind Study Comparing Megestrol Acetate at 100, 400, and 800 mg/Day, and Placebo in AIDS Patients With Anorexia and Cachexia", "orgStudyIdInfo"=>{"id"=>"025A"}, "secondaryIdInfos"=>[{"id"=>"MEG8807"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Megestrol acetate", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"35233", "city"=>"Birmingham", "state"=>"Alabama", "country"=>"United States", "facility"=>"Birmingham Veterans Administration Med Ctr / Univ of Alabama", "geoPoint"=>{"lat"=>33.52066, "lon"=>-86.80249}}, {"zip"=>"90801", "city"=>"Long Beach", "state"=>"California", "country"=>"United States", "facility"=>"Dr NS Tchekmedyian", "geoPoint"=>{"lat"=>33.76696, "lon"=>-118.18923}}, {"zip"=>"90067", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"Dr Stephen J Gabin Jr", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"92270", "city"=>"Rancho Mirage", "state"=>"California", "country"=>"United States", "facility"=>"Eisenhower Med Ctr", "geoPoint"=>{"lat"=>33.73974, "lon"=>-116.41279}}, {"zip"=>"80204", "city"=>"Denver", "state"=>"Colorado", "country"=>"United States", "facility"=>"Denver Public Health Dept", "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", "geoPoint"=>{"lat"=>38.89511, "lon"=>-77.03637}}, {"zip"=>"33125", "city"=>"Miami", "state"=>"Florida", "country"=>"United States", "facility"=>"Miami Veterans Administration Med Ctr", "geoPoint"=>{"lat"=>25.77427, "lon"=>-80.19366}}, {"zip"=>"60611", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Northwestern Univ Med School", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"12203", "city"=>"Albany", "state"=>"New York", "country"=>"United States", "facility"=>"Albany Med College / AIDS Treatment Ctr", "geoPoint"=>{"lat"=>42.65258, "lon"=>-73.75623}}, {"zip"=>"10010", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Community Research Initiative on AIDS", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"10011", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Saint Vincent's Hosp and 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"=>"19104", "city"=>"Philadelphia", "state"=>"Pennsylvania", "country"=>"United States", "facility"=>"Univ of Pennsylvania", "geoPoint"=>{"lat"=>39.95233, "lon"=>-75.16379}}, {"zip"=>"78284", "city"=>"San Antonio", "state"=>"Texas", "country"=>"United States", "facility"=>"Audie L Murphy Veterans Administration Hosp", "geoPoint"=>{"lat"=>29.42412, "lon"=>-98.49363}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Bristol-Myers Squibb", "class"=>"INDUSTRY"}}}}
