- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002067
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Phase 3
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90048
- Dr Mark Goldstein
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Oakland, California, United States, 94609
- Summitt Med Ctr / San Francisco Gen Hosp
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Palo Alto, California, United States, 94304
- Palo Alto Veterans Adm Med Ctr / Stanford Univ
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Rancho Mirage, California, United States, 92270
- Eisenhower Med Ctr
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Sacramento, California, United States, 95817
- UCD Med Ctr
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San Francisco, California, United States, 941102859
- San Francisco AIDS Clinic / San Francisco Gen Hosp
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San Francisco, California, United States, 94121
- San Francisco Veterans Administration Med Ctr
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Colorado
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Denver, Colorado, United States, 80204
- Denver Public Health Dept
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Florida
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Miami, Florida, United States, 33125
- Miami Veterans Administration Med Ctr
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Tampa, Florida, United States, 33612
- Univ of South Florida
-
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern Univ Med School
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New York
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New York, New York, United States, 10021
- Mem Sloan - Kettering Cancer Ctr
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Syracuse, New York, United States, 13210
- SUNY / Health Sciences Ctr at Syracuse
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Washington
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Seattle, Washington, United States, 98104
- Northwest Family Ctr at the Harbor View Med Ctr
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: Double
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Metabolic Diseases
- Signs and Symptoms, Digestive
- Nutrition Disorders
- Body Weight
- Body Weight Changes
- Emaciation
- Weight Loss
- Anorexia
- Wasting Syndrome
- Cachexia
- Physiological Effects of Drugs
- Antineoplastic Agents
- Antineoplastic Agents, Hormonal
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptives, Oral
- Contraceptive Agents, Female
- Contraceptives, Oral, Synthetic
- Contraceptives, Oral, Hormonal
- Central Nervous System Stimulants
- Appetite Stimulants
- Megestrol
- Megestrol Acetate
Other Study ID Numbers
- 025B
- MEG8809
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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