A Study of Different Doses of Megestrol Acetate in Patients With AIDS Who Have Anorexia and Malnutrition
NCT ID: NCT00002300
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
PHASE2
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.
Prior Medication:
Allowed:
* Ganciclovir.
Exclusion Criteria
Patients with the following are excluded:
* Dementia or evidence of mental incompetence which would preclude compliance with the protocol.
* 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.
Concurrent Medication:
Excluded:
* 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 eight weeks. (Patients may have been previously treated with AZT and failed or may currently be receiving AZT for at least 8 weeks.)
Patients with the following are excluded:
* Obstruction to food intake or impaired digestive/absorptive functions.
* Contraindications to high-dose 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.
* 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.
* Clinical or radiologic evidence of ascites or pleural effusions.
* 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 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.) 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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Birmingham Veterans Administration Med Ctr / Univ of Alabama
Birmingham, Alabama, United States
Dr NS Tchekmedyian
Long Beach, California, United States
Dr Stephen J Gabin Jr
Los Angeles, California, United States
Eisenhower Med Ctr
Rancho Mirage, California, United States
Denver Public Health Dept
Denver, Colorado, United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, United States
Veterans Administration Med Ctr
Washington D.C., District of Columbia, United States
Miami Veterans Administration Med Ctr
Miami, Florida, United States
Northwestern Univ Med School
Chicago, Illinois, United States
Albany Med College / AIDS Treatment Ctr
Albany, New York, United States
Community Research Initiative on AIDS
New York, New York, United States
Saint Vincent's Hosp and Med Ctr
New York, New York, United States
Mem Sloan - Kettering Cancer Ctr
New York, New York, United States
Univ of Pennsylvania
Philadelphia, Pennsylvania, United States
Audie L Murphy Veterans Administration Hosp
San Antonio, Texas, 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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MEG8807
Identifier Type: -
Identifier Source: secondary_id
025A
Identifier Type: -
Identifier Source: org_study_id