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| Sponsored by: |
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 |
| MedlinePlus related topics: | AIDS |
| Drug Information available for: | Megestrol acetate Megestrol |
| Study Type: | Interventional |
| Study Design: | Treatment, Double-Blind |
| 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 | |||||
| San Francisco AIDS Clinic / San Francisco Gen Hosp | |||||
| San Francisco, California, United States, 941102859 | |||||
| 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 | |||||
| Dr Mark Goldstein | |||||
| Los Angeles, California, United States, 90048 | |||||
| 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 | |||||
| Univ of South Florida | |||||
| Tampa, Florida, United States, 33612 | |||||
| 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 | |||||
| SUNY / Health Sciences Ctr at Syracuse | |||||
| Syracuse, New York, United States, 13210 | |||||
| Mem Sloan - Kettering Cancer Ctr | |||||
| New York, New York, United States, 10021 | |||||
| United States, Washington | |||||
| Northwest Family Ctr at the Harbor View Med Ctr | |||||
| Seattle, Washington, United States, 98104 | |||||
| Bristol-Myers Squibb |
More Information
BMS Clinical Trials Disclosure 
  |
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm 
  |
| Study ID Numbers: | 025B, MEG8809 |
| First Received: | November 2, 1999 |
| Last Updated: | October 1, 2007 |
| ClinicalTrials.gov Identifier: | NCT00002067 |
| Health Authority: | United States: Food and Drug Administration |
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