A Study of Different Doses of Megestrol Acetate in Patients With AIDS Who Have Anorexia and Malnutrition
Completed · Phase 2
Conditions studied: Anorexia, Cachexia, HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00002300
- Run by
- Bristol-Myers Squibb
- Last updated by the study team
- 2007-10-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patient must have:
- 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.
You may not qualify if…
- Co-existing Condition:
- 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.
Where it is running
- 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
Full record on ClinicalTrials.gov
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