A Study of Different Doses of Megestrol Acetate in Patients With AIDS Who Have Anorexia and Malnutrition

Official Title: “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”

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 characterize dose response in relation to weight gain. 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.

Intervention(s) in this Clinical Trial

• Drug: Megestrol acetate

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Bristol-Myers Squibb Industry

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00002300

Study ID Number: 025A

ClinicalTrials.gov Identifier: NCT00002300

Health Authority: United States: Food and Drug Administration

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