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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Megestrol; Megestrol Acetate

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.

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.