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| Sponsor: | Bristol-Myers Squibb |
|---|---|
| Information provided by: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00002067 |
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 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 III |
| Study Type: | Interventional |
| Study Design: | Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Phase III Randomized Double-Blind Study Comparing Megestrol Acetate at 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:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions are excluded:
Patients with the following are excluded:
Prior Medication:
Excluded:
Patients 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.
History of substance abuse and questionable current and future abstinence.
Contacts and Locations| United States, California | |
| Dr Mark Goldstein | |
| Los Angeles, California, United States, 90048 | |
| Summitt Med Ctr / San Francisco Gen Hosp | |
| Oakland, California, United States, 94609 | |
| Palo Alto Veterans Adm Med Ctr / Stanford Univ | |
| Palo Alto, California, United States, 94304 | |
| Eisenhower Med Ctr | |
| Rancho Mirage, California, United States, 92270 | |
| UCD Med Ctr | |
| Sacramento, California, United States, 95817 | |
| San Francisco AIDS Clinic / San Francisco Gen Hosp | |
| San Francisco, California, United States, 941102859 | |
| San Francisco Veterans Administration Med Ctr | |
| San Francisco, California, United States, 94121 | |
| United States, Colorado | |
| Denver Public Health Dept | |
| Denver, Colorado, United States, 80204 | |
| United States, Florida | |
| Miami Veterans Administration Med Ctr | |
| Miami, Florida, United States, 33125 | |
| Univ of South Florida | |
| Tampa, Florida, United States, 33612 | |
| United States, Illinois | |
| Northwestern Univ Med School | |
| Chicago, Illinois, United States, 60611 | |
| United States, New York | |
| Mem Sloan - Kettering Cancer Ctr | |
| New York, New York, United States, 10021 | |
| SUNY / Health Sciences Ctr at Syracuse | |
| Syracuse, New York, United States, 13210 | |
| United States, Washington | |
| Northwest Family Ctr at the Harbor View Med Ctr | |
| Seattle, Washington, United States, 98104 | |
More Information
| ClinicalTrials.gov Identifier: | NCT00002067 History of Changes |
| Other Study ID Numbers: | 025B, MEG8809 |
| Study First Received: | November 2, 1999 |
| Last Updated: | October 1, 2007 |
| Health Authority: | United States: Food and Drug Administration |
|
Body Weight T-Lymphocytes Nutritional Status Megestrol |
Acquired Immunodeficiency Syndrome Anorexia Cachexia Energy Intake |
|
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 |