A Study of Different Doses of Megestrol Acetate in Patients With AIDS Who Have Anorexia and Malnutrition
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
2 other identifiers
interventional
N/A
1 country
15
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
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.
- Prior Medication:
- Allowed:
- Ganciclovir.
You may not qualify if:
- 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.
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Birmingham Veterans Administration Med Ctr / Univ of Alabama
Birmingham, Alabama, 35233, United States
Dr NS Tchekmedyian
Long Beach, California, 90801, United States
Dr Stephen J Gabin Jr
Los Angeles, California, 90067, United States
Eisenhower Med Ctr
Rancho Mirage, California, 92270, United States
Denver Public Health Dept
Denver, Colorado, 80204, United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037, United States
Veterans Administration Med Ctr
Washington D.C., District of Columbia, 20422, United States
Miami Veterans Administration Med Ctr
Miami, Florida, 33125, United States
Northwestern Univ Med School
Chicago, Illinois, 60611, United States
Albany Med College / AIDS Treatment Ctr
Albany, New York, 12203, United States
Community Research Initiative on AIDS
New York, New York, 10010, United States
Saint Vincent's Hosp and Med Ctr
New York, New York, 10011, United States
Mem Sloan - Kettering Cancer Ctr
New York, New York, 10021, United States
Univ of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Audie L Murphy Veterans Administration Hosp
San Antonio, Texas, 78284, 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 2
- 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