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| Sponsor: | Bristol-Myers Squibb |
|---|---|
| Information provided by: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00002300 |
Purpose
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: | Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
Eligibility| 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:
Contacts and Locations| United States, Alabama | |
| Birmingham Veterans Administration Med Ctr / Univ of Alabama | |
| Birmingham, Alabama, United States, 35233 | |
| United States, California | |
| Dr NS Tchekmedyian | |
| Long Beach, California, United States, 90801 | |
| Dr Stephen J Gabin Jr | |
| Los Angeles, California, United States, 90067 | |
| Eisenhower Med Ctr | |
| Rancho Mirage, California, United States, 92270 | |
| United States, Colorado | |
| Denver Public Health Dept | |
| Denver, Colorado, United States, 80204 | |
| United States, District of Columbia | |
| George Washington Univ Med Ctr | |
| Washington, District of Columbia, United States, 20037 | |
| Veterans Administration Med Ctr | |
| Washington, District of Columbia, United States, 20422 | |
| 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 | |
| Albany Med College / AIDS Treatment Ctr | |
| Albany, New York, United States, 12203 | |
| Community Research Initiative on AIDS | |
| New York, New York, United States, 10010 | |
| Mem Sloan - Kettering Cancer Ctr | |
| New York, New York, United States, 10021 | |
| Saint Vincent's Hosp and Med Ctr | |
| New York, New York, United States, 10011 | |
| 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 | |
More Information
| ClinicalTrials.gov Identifier: | NCT00002300 History of Changes |
| Other Study ID Numbers: | 025A, MEG8807 |
| Study First Received: | November 2, 1999 |
| Last Updated: | October 1, 2007 |
| Health Authority: | United States: Food and Drug Administration |
|
T-Lymphocytes Megestrol Dose-Response Relationship, Drug |
Acquired Immunodeficiency Syndrome Anorexia Cachexia |
|
HIV Infections Acquired Immunodeficiency Syndrome Anorexia Cachexia Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Signs and Symptoms, Digestive Signs and Symptoms |
Emaciation Weight Loss Body Weight Changes Body Weight Megestrol Acetate Megestrol Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Appetite Stimulants Central Nervous System Stimulants Physiological Effects of Drugs Central Nervous System Agents Contraceptives, Oral, Synthetic |