Phase II-III Randomized Double-Blind Study Comparing Megestrol Acetate at 100, 400, and 800 mg/Day, and Placebo in AIDS Patients With Anorexia and Cachexia
Inclusion Criteria
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.
Prior Medication:
Allowed:
- Ganciclovir.
Exclusion Criteria
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.
- 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.