A Study Comparing Megestrol Acetate at 800 mg/Day, and Placebo in AIDS Patients With Anorexia and Cachexia
Phase III Randomized Double-Blind Study Comparing Megestrol Acetate at 800 mg/Day, and Placebo in AIDS Patients With Anorexia and Cachexia
2 other identifiers
interventional
N/A
1 country
14
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
14 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedOctober 2, 2007
October 1, 2007
November 2, 1999
October 1, 2007
Conditions
Keywords
Interventions
Eligibility Criteria
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.
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
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
Related Publications (1)
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.
PMID: 9066597BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
October 2, 2007
Record last verified: 2007-10