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Sponsored by: |
Bristol-Myers Squibb |
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Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00002300 |
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.
Condition | Intervention | Phase |
---|---|---|
Anorexia Cachexia HIV Infections |
Drug: Megestrol acetate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Double-Blind |
Official Title: | 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 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patient must have:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following are excluded:
Concurrent Medication:
Excluded:
Patients with the following are excluded:
Prior Medication:
Excluded:
United States, Alabama | |
Birmingham Veterans Administration Med Ctr / Univ of Alabama | |
Birmingham, Alabama, United States, 35233 | |
United States, California | |
Dr Stephen J Gabin Jr | |
Los Angeles, California, United States, 90067 | |
Eisenhower Med Ctr | |
Rancho Mirage, California, United States, 92270 | |
Dr NS Tchekmedyian | |
Long Beach, California, United States, 90801 | |
United States, Colorado | |
Denver Public Health Dept | |
Denver, Colorado, United States, 80204 | |
United States, District of Columbia | |
Veterans Administration Med Ctr | |
Washington, District of Columbia, United States, 20422 | |
George Washington Univ Med Ctr | |
Washington, District of Columbia, United States, 20037 | |
United States, Florida | |
Miami Veterans Administration Med Ctr | |
Miami, Florida, United States, 33125 | |
United States, Illinois | |
Northwestern Univ Med School | |
Chicago, Illinois, United States, 60611 | |
United States, New York | |
Saint Vincent's Hosp and Med Ctr | |
New York, New York, United States, 10011 | |
Community Research Initiative on AIDS | |
New York, New York, United States, 10010 | |
Albany Med College / AIDS Treatment Ctr | |
Albany, New York, United States, 12203 | |
Mem Sloan - Kettering Cancer Ctr | |
New York, New York, United States, 10021 | |
United States, Pennsylvania | |
Univ of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, Texas | |
Audie L Murphy Veterans Administration Hosp | |
San Antonio, Texas, United States, 78284 |
Study ID Numbers: | 025A, MEG8807 |
Study First Received: | November 2, 1999 |
Last Updated: | October 1, 2007 |
ClinicalTrials.gov Identifier: | NCT00002300 |
Health Authority: | United States: Food and Drug Administration |
T-Lymphocytes Megestrol Dose-Response Relationship, Drug |
Acquired Immunodeficiency Syndrome Anorexia Cachexia |
Sexually Transmitted Diseases, Viral Signs and Symptoms, Digestive Acquired Immunodeficiency Syndrome Cachexia Emaciation Megestrol Immunologic Deficiency Syndromes Body Weight Virus Diseases |
Signs and Symptoms Malnutrition HIV Infections Weight Loss Sexually Transmitted Diseases Body Weight Changes Anorexia Retroviridae Infections Megestrol Acetate |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Antineoplastic Agents, Hormonal Contraceptive Agents Antineoplastic Agents Contraceptives, Oral Physiological Effects of Drugs Contraceptive Agents, Female |
Central Nervous System Stimulants Reproductive Control Agents Infection Pharmacologic Actions Therapeutic Uses Lentivirus Infections Contraceptives, Oral, Synthetic Central Nervous System Agents Appetite Stimulants |