A Study Comparing Megestrol Acetate at 800 mg/Day, and Placebo in AIDS Patients With Anorexia and Cachexia
Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anorexia; Cachexia; HIV Infections
Intervention: Megestrol acetate (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Bristol-Myers Squibb
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.
Clinical Details
Official title: Phase III Randomized Double-Blind Study Comparing Megestrol Acetate at 800 mg/Day, and Placebo in AIDS Patients With Anorexia and Cachexia
Study design: Masking: Double-Blind, Primary Purpose: Treatment
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Dr Mark Goldstein, Los Angeles, California 90048, United States
Summitt Med Ctr / San Francisco Gen Hosp, Oakland, California 94609, United States
Palo Alto Veterans Adm Med Ctr / Stanford Univ, Palo Alto, California 94304, United States
Eisenhower Med Ctr, Rancho Mirage, California 92270, United States
UCD Med Ctr, Sacramento, California 95817, United States
San Francisco AIDS Clinic / San Francisco Gen Hosp, San Francisco, California 941102859, United States
San Francisco Veterans Administration Med Ctr, San Francisco, California 94121, United States
Denver Public Health Dept, Denver, Colorado 80204, United States
Miami Veterans Administration Med Ctr, Miami, Florida 33125, United States
Univ of South Florida, Tampa, Florida 33612, United States
Northwestern Univ Med School, Chicago, Illinois 60611, United States
Mem Sloan - Kettering Cancer Ctr, New York, New York 10021, United States
SUNY / Health Sciences Ctr at Syracuse, Syracuse, New York 13210, United States
Northwest Family Ctr at the Harbor View Med Ctr, Seattle, Washington 98104, United States
Additional Information
BMS Clinical Trials Disclosure For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm
Related publications: Strang P. The effect of megestrol acetate on anorexia, weight loss and cachexia in cancer and AIDS patients (review). Anticancer Res. 1997 Jan-Feb;17(1B):657-62. Review.
Last updated: October 1, 2007
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