Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:37 PM
Study NCT ID:
NCT00002067
Status:
COMPLETED
Last Update Posted:
2007-10-02
First Post:
1999-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study Comparing Megestrol Acetate at 800 mg/Day, and Placebo in AIDS Patients With Anorexia and Cachexia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000855', 'term': 'Anorexia'}, {'id': 'D002100', 'term': 'Cachexia'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D013851', 'term': 'Thinness'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': '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': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019290', 'term': 'Megestrol Acetate'}], 'ancestors': [{'id': 'D008535', 'term': 'Megestrol'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], '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': ['Body Weight', 'T-Lymphocytes', 'Nutritional Status', 'Megestrol', 'Acquired Immunodeficiency Syndrome', 'Anorexia', 'Cachexia', 'Energy Intake'], '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 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\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following conditions are excluded:\n\n* Dementia or evidence of mental incompetence which would preclude compliance with the protocol.\n* Severe 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.\n* Clinical or radiologic evidence of ascites or pleural effusions.\n\nPatients with the following are excluded:\n\n* Obstruction to food intake or impaired digestive/absorptive functions.\n* Contraindications to 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* Clinical or radiologic evidence of ascites or pleural effusions.\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.)\n\nPatients 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\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.)\n\nHistory of substance abuse and questionable current and future abstinence.'}, 'identificationModule': {'nctId': 'NCT00002067', 'briefTitle': 'A Study Comparing Megestrol Acetate at 800 mg/Day, and Placebo in AIDS Patients With Anorexia and Cachexia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Phase III Randomized Double-Blind Study Comparing Megestrol Acetate at 800 mg/Day, and Placebo in AIDS Patients With Anorexia and Cachexia', 'orgStudyIdInfo': {'id': '025B'}, 'secondaryIdInfos': [{'id': 'MEG8809'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Megestrol acetate', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Dr Mark Goldstein', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94609', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Summitt Med Ctr / San Francisco Gen Hosp', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Palo Alto Veterans Adm Med Ctr / Stanford Univ', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '92270', 'city': 'Rancho Mirage', 'state': 'California', 'country': 'United States', 'facility': 'Eisenhower Med Ctr', 'geoPoint': {'lat': 33.73974, 'lon': -116.41279}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'UCD Med Ctr', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '941102859', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'San Francisco AIDS Clinic / San Francisco Gen Hosp', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94121', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'San Francisco Veterans Administration Med Ctr', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80204', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Denver Public Health Dept', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '33125', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Miami Veterans Administration Med Ctr', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Univ of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern Univ Med School', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'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': '13210', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY / Health Sciences Ctr at Syracuse', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Northwest Family Ctr at the Harbor View Med Ctr', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}}}}