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| Sponsored by: |
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: | 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 |
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 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 | |
More Information
| Study ID Numbers: | 025A, MEG8807 |
| Study First Received: | November 2, 1999 |
| Last Updated: | October 1, 2007 |
| ClinicalTrials.gov Identifier: | NCT00002300 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
T-Lymphocytes Megestrol Dose-Response Relationship, Drug |
Acquired Immunodeficiency Syndrome Anorexia Cachexia |
|
Sexually Transmitted Diseases, Viral Antineoplastic Agents, Hormonal Signs and Symptoms, Digestive Contraceptive Agents Contraceptives, Oral Acquired Immunodeficiency Syndrome Contraceptive Agents, Female Cachexia Central Nervous System Stimulants 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 Appetite Stimulants Megestrol Acetate |
|
Sexually Transmitted Diseases, Viral Slow Virus Diseases Signs and Symptoms, Digestive Contraceptive Agents Antineoplastic Agents Contraceptives, Oral Physiological Effects of Drugs Contraceptive Agents, Female Cachexia Reproductive Control Agents Infection Body Weight Signs and Symptoms Therapeutic Uses Weight Loss |
Body Weight Changes Contraceptives, Oral, Synthetic Retroviridae Infections Appetite Stimulants RNA Virus Infections Immune System Diseases Antineoplastic Agents, Hormonal Acquired Immunodeficiency Syndrome Central Nervous System Stimulants Emaciation Megestrol Pharmacologic Actions Immunologic Deficiency Syndromes Virus Diseases HIV Infections |