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.