Nctid:
NCT00000737
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-09-05"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000019247", "term"=>"HIV Wasting Syndrome"}, {"id"=>"D000019282", "term"=>"Wasting Syndrome"}, {"id"=>"D000013577", "term"=>"Syndrome"}, {"id"=>"D000002100", "term"=>"Cachexia"}], "ancestors"=>[{"id"=>"D000004194", "term"=>"Disease"}, {"id"=>"D000010335", "term"=>"Pathologic Processes"}, {"id"=>"D000015658", "term"=>"HIV Infections"}, {"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"}, {"id"=>"D000015431", "term"=>"Weight Loss"}, {"id"=>"D000001836", "term"=>"Body Weight Changes"}, {"id"=>"D000001835", "term"=>"Body Weight"}, {"id"=>"D000013851", "term"=>"Thinness"}, {"id"=>"D000008659", "term"=>"Metabolic Diseases"}, {"id"=>"D000009748", "term"=>"Nutrition Disorders"}], "browseLeaves"=>[{"id"=>"M16355", "name"=>"Syndrome", "asFound"=>"Syndrome", "relevance"=>"HIGH"}, {"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M5114", "name"=>"Body Weight", "relevance"=>"LOW"}, {"id"=>"M18102", "name"=>"Weight Loss", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "relevance"=>"LOW"}, {"id"=>"M21265", "name"=>"Wasting Syndrome", "asFound"=>"Wasting Syndrome", "relevance"=>"HIGH"}, {"id"=>"M5363", "name"=>"Cachexia", "asFound"=>"Wasting Syndrome", "relevance"=>"HIGH"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M21232", "name"=>"HIV Wasting Syndrome", "asFound"=>"HIV Wasting Syndrome", "relevance"=>"HIGH"}, {"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"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M10200", "name"=>"Immune System Diseases", "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"=>"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"=>"Nutritional and Metabolic Diseases", "abbrev"=>"BC18"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000008535", "term"=>"Megestrol"}, {"id"=>"D000019290", "term"=>"Megestrol Acetate"}, {"id"=>"D000013759", "term"=>"Dronabinol"}], "ancestors"=>[{"id"=>"D000006213", "term"=>"Hallucinogens"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000011619", "term"=>"Psychotropic Drugs"}, {"id"=>"D000018712", "term"=>"Analgesics, Non-Narcotic"}, {"id"=>"D000000700", "term"=>"Analgesics"}, {"id"=>"D000018689", "term"=>"Sensory System Agents"}, {"id"=>"D000018373", "term"=>"Peripheral Nervous System Agents"}, {"id"=>"D000063386", "term"=>"Cannabinoid Receptor Agonists"}, {"id"=>"D000063385", "term"=>"Cannabinoid Receptor Modulators"}, {"id"=>"D000018377", "term"=>"Neurotransmitter Agents"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000006728", "term"=>"Hormones"}, {"id"=>"D000006730", "term"=>"Hormones, Hormone Substitutes, and Hormone Antagonists"}, {"id"=>"D000003278", "term"=>"Contraceptives, Oral, Hormonal"}, {"id"=>"D000003276", "term"=>"Contraceptives, Oral"}, {"id"=>"D000003271", "term"=>"Contraceptive Agents, Female"}, {"id"=>"D000003270", "term"=>"Contraceptive Agents"}, {"id"=>"D000012102", "term"=>"Reproductive Control Agents"}, {"id"=>"D000080066", "term"=>"Contraceptive Agents, Hormonal"}, {"id"=>"D000003280", "term"=>"Contraceptives, Oral, Synthetic"}, {"id"=>"D000018931", "term"=>"Antineoplastic Agents, Hormonal"}, {"id"=>"D000000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D000019167", "term"=>"Appetite Stimulants"}, {"id"=>"D000000697", "term"=>"Central Nervous System Stimulants"}], "browseLeaves"=>[{"id"=>"M11518", "name"=>"Megestrol", "asFound"=>"Both arms", "relevance"=>"HIGH"}, {"id"=>"M21272", "name"=>"Megestrol Acetate", "asFound"=>"Glioblastoma Multiforme", "relevance"=>"HIGH"}, {"id"=>"M16527", "name"=>"Dronabinol", "asFound"=>"Induce", "relevance"=>"HIGH"}, {"id"=>"M9305", "name"=>"Hallucinogens", "relevance"=>"LOW"}, {"id"=>"M14474", "name"=>"Psychotropic Drugs", "relevance"=>"LOW"}, {"id"=>"M4032", "name"=>"Analgesics", "relevance"=>"LOW"}, {"id"=>"M20786", "name"=>"Analgesics, Non-Narcotic", "relevance"=>"LOW"}, {"id"=>"M20504", "name"=>"Neurotransmitter Agents", "relevance"=>"LOW"}, {"id"=>"M9789", "name"=>"Hormones", "relevance"=>"LOW"}, {"id"=>"M9788", "name"=>"Hormone Antagonists", "relevance"=>"LOW"}, {"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"}, {"name"=>"Analgesics", "abbrev"=>"Analg"}, {"name"=>"Psychotropic Drugs", "abbrev"=>"PsychDr"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>56}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1994-01", "lastUpdateSubmitDate"=>"2008-08-22", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2008-08-25", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Weight Loss", "Megestrol", "Cachexia", "Eating Disorders", "Tetrahydrocannabinol", "Appetite"], "conditions"=>["Cachexia", "HIV Infections", "HIV Wasting Syndrome"]}, "referencesModule"=>{"references"=>[{"pmid"=>"9071430", "type"=>"BACKGROUND", "citation"=>"Timpone JG, Wright DJ, Li N, Egorin MJ, Enama ME, Mayers J, Galetto G. The safety and pharmacokinetics of single-agent and combination therapy with megestrol acetate and dronabinol for the treatment of HIV wasting syndrome. The DATRI 004 Study Group. Division of AIDS Treatment Research Initiative. AIDS Res Hum Retroviruses. 1997 Mar 1;13(4):305-15. doi: 10.1089/aid.1997.13.305."}]}, "descriptionModule"=>{"briefSummary"=>"To obtain data on the safety of administering megestrol acetate and dronabinol as single agents or in combination to patients with human immunodeficiency virus (HIV)-wasting syndrome. To obtain preliminary data on the efficacy of single agent and combination therapy with megestrol acetate and dronabinol with regard to weight gain, appetite increase and quality of life in this patient population. To obtain steady-state pharmacokinetics data when megestrol acetate and dronabinol are administered as single agents and in combination.\n\nHIV-wasting syndrome, which is characterized by severely debilitating anorexia and weight loss, is of particular concern because it can exacerbate the primary illness and is associated with a poor prognosis. Attempts at maintaining body mass through the use of megestrol acetate and dronabinol, two anti-cachectic drugs, may prolong survival.", "detailedDescription"=>"HIV-wasting syndrome, which is characterized by severely debilitating anorexia and weight loss, is of particular concern because it can exacerbate the primary illness and is associated with a poor prognosis. Attempts at maintaining body mass through the use of megestrol acetate and dronabinol, two anti-cachectic drugs, may prolong survival.\n\nFifty-six patients are randomized to one of four treatment arms, as follows: high-dose megestrol acetate alone; dronabinol alone; high-dose megestrol acetate combined with dronabinol; or low-dose megestrol acetate combined with dronabinol. Treatment continues for 12 weeks. Patients are evaluated for toxicity, preliminary evidence of response (e.g., weight gain), and steady-state pharmacokinetics of drug therapies."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Zidovudine (AZT), didanosine (ddI), and dideoxycytidine (ddC). If initiating new antiretroviral therapy, patient must have been on a stable dose for at least 4 weeks prior to study entry.\n* Maintenance or suppressive therapy with any of the following, provided patient has been on a stable dose for at least 1 week prior to study entry:\n* Ganciclovir or foscarnet for CMV retinitis.\n* Fluconazole, amphotericin B, or flucytosine for cryptococcosis.\n* Amphotericin B for disseminated histoplasmosis.\n* Pyrimethamine, sulfadiazine, dapsone, or clindamycin for toxoplasmosis.\n* Amikacin, clarithromycin, clofazimine, ethambutol, ciprofloxacin, or rifampin for disseminated Mycobacterium avium complex.\n* Isoniazid, rifampin, ethambutol, or pyrazinamide for M. tuberculosis.\n* Any of the following provided patient is on a stable dose for at least 1 week prior to study entry:\n* Trimethoprim-sulfamethoxazole, aerosolized pentamidine, or dapsone for Pneumocystis carinii prophylaxis.\n* Clotrimazole troches, nystatin suspension, ketoconazole, or fluconazole for oral candidiasis.\n* Oral acyclovir for mucocutaneous herpes simplex.\n* Narcotic analgesics, tranquilizers, sedative-hypnotics, or anticholinergic agents provided patient is on a stable dose for at least 1 week prior to study entry.\n\nPatients must have:\n\n* HIV infection.\n* HIV-wasting syndrome and anorexia.\n* Life expectancy of at least 4 months.\n* Ability to tolerate oral therapy, feed themselves, and have access to as much food as they desire with no dietary restrictions.\n\nPrior Medication:\n\nAllowed:\n\n* Prior zidovudine (AZT), didanosine (ddI), and dideoxycytidine (ddC).\n* Prior maintenance or suppressive therapy for certain opportunistic infections, as follows:\n* Ganciclovir or foscarnet for CMV retinitis.\n* Fluconazole, amphotericin B, or flucytosine for cryptococcosis.\n* Amphotericin B for disseminated histoplasmosis.\n* Pyrimethamine, sulfadiazine, dapsone, or clindamycin for toxoplasmosis.\n* Amikacin, clarithromycin, clofazimine, ethambutol, ciprofloxacin, or rifampin for disseminated Mycobacterium avium complex.\n* Isoniazid, rifampin, ethambutol, or pyrazinamide for M. tuberculosis.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\n* Major, acute opportunistic infections.\n* Active neoplasms other than Kaposi's sarcoma or localized skin carcinoma.\n* Diabetes, congestive heart failure, clinical ascites, or uncontrolled hypertension.\n* Persistent grade 3/4 diarrhea.\n* Impaired oral intake, such as occurs with Candida esophagitis or severe mouth ulcers.\n* Clinically significant cardiac arrhythmias.\n* Requirement for anticonvulsants for seizure disorder.\n\nConcurrent Medication:\n\nExcluded:\n\n* Marijuana use.\n* Anabolic steroids.\n* Anticonvulsants for seizure disorders.\n* Alcohol or barbiturates.\n\nPatients with the following prior conditions are excluded:\n\n* Diagnosis of a major, acute opportunistic infection within 2 months prior to study entry.\n* Hospitalization within 2 weeks prior to study entry.\n* History of hypersensitivity reactions to megestrol acetate, dronabinol, or sesame oil (a component of the dronabinol capsules).\n* History of thromboembolic events.\n* History of psychiatric disorder other than depression.\n\nPrior Medication:\n\nExcluded:\n\n* Prior dronabinol.\n* Megestrol acetate within 2 months prior to study entry.\n* Marijuana within 1 month prior to study entry.\n* Anabolic steroids within 3 months prior to study entry.\n\nCurrent drug or alcohol abuse (patients with a history of occasional marijuana use are eligible provided they have abstained from its use for 1 month prior to study entry and agree to refrain from marijuana use for the study period)."}, "identificationModule"=>{"nctId"=>"NCT00000737", "briefTitle"=>"A Phase I/II Study to Evaluate Single Agent and Combination Therapy With Megestrol Acetate and Dronabinol for the Treatment of HIV-Wasting Syndrome", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "officialTitle"=>"A Phase I/II Study to Evaluate Single Agent and Combination Therapy With Megestrol Acetate and Dronabinol for the Treatment of HIV-Wasting Syndrome", "orgStudyIdInfo"=>{"id"=>"DATRI 004"}}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Dronabinol", "type"=>"DRUG"}, {"name"=>"Megestrol acetate", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"802044507", "city"=>"Denver", "state"=>"Colorado", "country"=>"United States", "facility"=>"Denver Public Health Dept", "geoPoint"=>{"lat"=>39.73915, "lon"=>-104.9847}}, {"zip"=>"60612", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Univ of Illinois", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"67214", "city"=>"Wichita", "state"=>"Kansas", "country"=>"United States", "facility"=>"Univ of Kansas School of Medicine", "geoPoint"=>{"lat"=>37.69224, "lon"=>-97.33754}}, {"zip"=>"701122699", "city"=>"New Orleans", "state"=>"Louisiana", "country"=>"United States", "facility"=>"Tulane Univ Med School", "geoPoint"=>{"lat"=>29.95465, "lon"=>-90.07507}}, {"zip"=>"21201", "city"=>"Baltimore", "state"=>"Maryland", "country"=>"United States", "facility"=>"Univ of Maryland at Baltimore / Veterans Adm", "geoPoint"=>{"lat"=>39.29038, "lon"=>-76.61219}}, {"zip"=>"63110", "city"=>"St Louis", "state"=>"Missouri", "country"=>"United States", "facility"=>"Washington Univ", "geoPoint"=>{"lat"=>38.62727, "lon"=>-90.19789}}, {"zip"=>"11203", "city"=>"Brooklyn", "state"=>"New York", "country"=>"United States", "facility"=>"SUNY / Health Sciences Ctr at Brooklyn", "geoPoint"=>{"lat"=>40.6501, "lon"=>-73.94958}}, {"zip"=>"972109951", "city"=>"Portland", "state"=>"Oregon", "country"=>"United States", "facility"=>"Portland Veterans Adm Med Ctr / Rsch & Education Grp", "geoPoint"=>{"lat"=>45.52345, "lon"=>-122.67621}}, {"zip"=>"02908", "city"=>"Providence", "state"=>"Rhode Island", "country"=>"United States", "facility"=>"Univ of Rhode Island / College of Pharmacy", "geoPoint"=>{"lat"=>41.82399, "lon"=>-71.41283}}], "overallOfficials"=>[{"name"=>"Galetto G", "role"=>"STUDY_CHAIR"}, {"name"=>"Egorin M", "role"=>"STUDY_CHAIR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}, "collaborators"=>[{"name"=>"Roxane Laboratories", "class"=>"INDUSTRY"}, {"name"=>"Bristol-Myers Squibb", "class"=>"INDUSTRY"}]}}}