A Study Comparing Megestrol Acetate at 800 mg/Day, and Placebo in AIDS Patients With Anorexia and Cachexia

Inclusion criteria

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.

Exclusion criteria

Co-existing Condition:

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.