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

Launched by BRISTOL-MYERS SQUIBB · Aug 30, 2001

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility 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.