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Phase III Randomized Double-Blind Study Comparing Megestrol Acetate at 800 mg/day, and Placebo in AIDS Patients With Anorexia and Cachexia Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Phase III Randomized Double-Blind Study Comparing Megestrol Acetate at 800 mg/day, and Placebo in AIDS Patients With Anorexia and Cachexia conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Phase III Randomized Double-Blind Study Comparing Megestrol Acetate at 800 mg/day, and Placebo in AIDS Patients With Anorexia and Cachexia Clinical research trials and Phase III Randomized Double-Blind Study Comparing Megestrol Acetate at 800 mg/day, and Placebo in AIDS Patients With Anorexia and Cachexia medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Phase III Randomized Double-Blind 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 Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Phase III Randomized Double-Blind Study Comparing Megestrol Acetate at 800 mg/day, and Placebo in AIDS Patients With Anorexia and Cachexia clinical trial. Subjects often receive the most expert healthcare possible for their Phase III Randomized Double-Blind Study Comparing Megestrol Acetate at 800 mg/day, and Placebo in AIDS Patients With Anorexia and Cachexia condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Phase III Randomized Double-Blind 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
Phase III Randomized Double-Blind Study Comparing Megestrol Acetate at 800 mg/day, and Placebo in AIDS Patients With Anorexia and Cachexia
For Condition: Anorexia,Cachexia,HIV Infections
Status: No longer recruiting
Sponsor(s): Bristol-Myers Squibb ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Double-Blind
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment:
Location and Contact Information:
Miami Veterans Administration Med Ctr
Miami, Florida, 33125
United States
UCD Med Ctr
Sacramento, California, 95817
United States
Mem Sloan - Kettering Cancer Ctr
New York City, New York, 10021
United States
Dr Mark Goldstein
Los Angeles, California, 90048
United States
SUNY / Health Sciences Ctr at Syracuse
Syracuse, New York, 13210
United States
Eisenhower Med Ctr
Rancho Mirage, California, 92270
United States
Summitt Med Ctr / San Francisco Gen Hosp
Oakland, California, 94609
United States
San Francisco Veterans Administration Med Ctr
San Francisco, California, 94121
United States
Palo Alto Veterans Adm Med Ctr / Stanford Univ
Palo Alto, California, 94304
United States
Denver Public Health Dept
Denver, Colorado, 80204
United States
Northwest Family Ctr at the Harbor View Med Ctr
Seattle, Washington, 98104
United States
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Univ of South Florida
Tampa, Florida, 33612
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Additional Information:
Study ID Numbers: 025B; MEG8809
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002067
Other Anorexia Studies:
1. Phase I/II Study of Curdlan Sulfate
2. A Study of AL721 in HIV-Infected Patients with Swollen Lymph Nodes
3. The Effects of Combination Anti-HIV Medication on Human Papillomavirus (HPV) in HIV-Infected Women
4. A Phase I Study of the Safety and Immunogenicity of rgp120/HIV-1IIIB Vaccine in Healthy Adult Subjects (NOTE: Study extended ONLY for subjects who have previously received rgp120/HIV-1IIIB or rgp120/HIV-1MN on VEU 006 or VEU 006 Rollover study)
5. Study of Perinatal Transmission of Zidovudine-Resistant HIV Among Pregnant Women Treated with Zidovudine
Related Studies:
Other Anorexia Clinical Trials
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Phase III Randomized Double-Blind Study Comparing Megestrol Acetate at 800 mg/day, and Placebo in AIDS Patients With Anorexia and Cachexia
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