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

Completed · Phase 3

Conditions studied: Anorexia, Cachexia, HIV Infections

In brief

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.

Key facts

Study ID: NCT00002067
Run by: Bristol-Myers Squibb
Last updated by the study team: 2007-10-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Dr Mark Goldstein — Los Angeles, California, United States
Summitt Med Ctr / San Francisco Gen Hosp — Oakland, California, United States
Palo Alto Veterans Adm Med Ctr / Stanford Univ — Palo Alto, California, United States
Eisenhower Med Ctr — Rancho Mirage, California, United States
UCD Med Ctr — Sacramento, California, United States
San Francisco AIDS Clinic / San Francisco Gen Hosp — San Francisco, California, United States
San Francisco Veterans Administration Med Ctr — San Francisco, California, United States
Denver Public Health Dept — Denver, Colorado, United States
Miami Veterans Administration Med Ctr — Miami, Florida, United States
Univ of South Florida — Tampa, Florida, United States
Northwestern Univ Med School — Chicago, Illinois, United States
Mem Sloan - Kettering Cancer Ctr — New York, New York, United States
SUNY / Health Sciences Ctr at Syracuse — Syracuse, New York, United States
Northwest Family Ctr at the Harbor View Med Ctr — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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