A Study Comparing Megestrol Acetate at 800 mg/Day, and Placebo in AIDS Patients With Anorexia and Cachexia
NCT ID: NCT00002067
Last Updated: 2007-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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TREATMENT
DOUBLE
Interventions
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Megestrol acetate
Eligibility Criteria
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Inclusion Criteria
* Confirmed diagnosis of AIDS (CDC definition).
* Documented weight loss or anorexia.
* Life expectancy = or \> 20 weeks.
* The perception that the weight loss is a detriment to their well-being.
* Ability to provide informed consent, read and write English.
Exclusion Criteria
Patients with the following conditions are excluded:
* Dementia or evidence of mental incompetence which would preclude compliance with the protocol.
* Severe diarrhea defined as 5 or more watery stools per day for at least 7 days.
* Active uncontrolled systemic infections at the start of treatment.
* Patients may not be entered for at least 2 weeks after acute infection.
* Clinical or radiologic evidence of ascites or pleural effusions.
Patients with the following are excluded:
* Obstruction to food intake or impaired digestive/absorptive functions.
* Contraindications to megestrol acetate (poorly controlled hypertension or heart failure or deep vein thrombosis).
* Inability to consent or be available for close follow-up.
* Active systemic infections at the start of treatment.
* Clinical or radiologic evidence of ascites or pleural effusions.
* Patients who have been hospitalized or have suffered an exacerbation of their illness associated with weight loss within the past 2 weeks are excluded.
* Menstruating female patients are excluded.
Prior Medication:
Excluded:
* Corticosteroids.
* Anabolic steroids.
* Marijuana.
* Megestrol acetate.
* Patients who have been started on zidovudine (AZT) within 8 weeks. (Patients may have been previously treated with AZT and failed or may currently be receiving AZT for at least 8 weeks.)
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.
* Patients who have been started on zidovudine (AZT) within 8 weeks. (Patients may have been previously treated with AZT and failed or may currently be receiving AZT for at least 8 weeks.)
History of substance abuse and questionable current and future abstinence.
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Locations
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Dr Mark Goldstein
Los Angeles, California, United States
Summitt Med Ctr / San Francisco Gen Hosp
Oakland, California, United States
Palo Alto Veterans Adm Med Ctr / Stanford Univ
Palo Alto, California, United States
Eisenhower Med Ctr
Rancho Mirage, California, United States
UCD Med Ctr
Sacramento, California, United States
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, United States
San Francisco Veterans Administration Med Ctr
San Francisco, California, United States
Denver Public Health Dept
Denver, Colorado, United States
Miami Veterans Administration Med Ctr
Miami, Florida, United States
Univ of South Florida
Tampa, Florida, United States
Northwestern Univ Med School
Chicago, Illinois, United States
Mem Sloan - Kettering Cancer Ctr
New York, New York, United States
SUNY / Health Sciences Ctr at Syracuse
Syracuse, New York, United States
Northwest Family Ctr at the Harbor View Med Ctr
Seattle, Washington, United States
Countries
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References
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Strang P. The effect of megestrol acetate on anorexia, weight loss and cachexia in cancer and AIDS patients (review). Anticancer Res. 1997 Jan-Feb;17(1B):657-62.
Other Identifiers
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MEG8809
Identifier Type: -
Identifier Source: secondary_id
025B
Identifier Type: -
Identifier Source: org_study_id