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A Study of Different Doses of Megestrol Acetate in Patients with AIDS Who Have Anorexia and Malnutrition Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about A Study of Different Doses of Megestrol Acetate in Patients with AIDS Who Have Anorexia and Malnutrition conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Study of Different Doses of Megestrol Acetate in Patients with AIDS Who Have Anorexia and Malnutrition Clinical research trials and A Study of Different Doses of Megestrol Acetate in Patients with AIDS Who Have Anorexia and Malnutrition health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like A Study of Different Doses of Megestrol Acetate in Patients with AIDS Who Have Anorexia and Malnutrition. A Study of Different Doses of Megestrol Acetate in Patients with AIDS Who Have Anorexia and Malnutrition Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a A Study of Different Doses of Megestrol Acetate in Patients with AIDS Who Have Anorexia and Malnutrition clinical trial. Subjects frequently get the best healthcare possible for their A Study of Different Doses of Megestrol Acetate in Patients with AIDS Who Have Anorexia and Malnutrition condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Study of Different Doses of Megestrol Acetate in Patients with AIDS Who Have Anorexia and Malnutrition  A Study of Different Doses of Megestrol Acetate in Patients with AIDS Who Have Anorexia and Malnutrition
A Study of Different Doses of Megestrol Acetate in Patients with AIDS Who Have Anorexia and Malnutrition
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 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.
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. Prior Medication: Allowed: - Ganciclovir. Exclusion Criteria 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. - 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. - Clinical or radiologic evidence of ascites or pleural effusions. - 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 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.) History of substance abuse and questionable current and future abstinence.
Total Enrollment:
Location and Contact Information:
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
United States
Mem Sloan - Kettering Cancer Ctr
New York City, New York, 10021
United States
Audie L Murphy Veterans Administration Hosp
San Antonio, Texas, 78284
United States
Miami Veterans Administration Med Ctr
Miami, Florida, 33125
United States
Birmingham Veterans Administration Med Ctr / Univ of Alabama
Birmingham, Alabama, 35233
United States
Denver Public Health Dept
Denver, Colorado, 80204
United States
Community Research Initiative on AIDS
New York City, New York, 10010
United States
Univ of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Saint Vincent's Hosp and Med Ctr
New York City, New York, 10011
United States
Albany Med College / AIDS Treatment Ctr
Albany, New York, 12203
United States
Dr Stephen J Gabin Jr
Los Angeles, California, 90067
United States
Eisenhower Med Ctr
Rancho Mirage, California, 92270
United States
Veterans Administration Med Ctr
Washington D.C., District of Columbia, 20422
United States
Dr NS Tchekmedyian
Long Beach, California, 90801
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Additional Information:
Study ID Numbers: 025A; MEG8807
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002300
Other Hiv Infections Studies:
1. The Safety and Effectiveness of Cidofovir in the Treatment of Venereal Warts in HIV-Infected Patients
2. A Comparison of ISIS 2922 Used Immediately or Later in Patients with Cytomegalovirus (CMV) of the Eyes
3. The Safety and Effectiveness of Clarithromycin Plus Zidovudine or Dideoxyinosine in the Treatment of Mycobacterium Avium Complex (MAC) Infections in Children with AIDS
4. A Study of Psychosocial and Behavioral Determinants of Differential Rates of Participant Compliance in CPCRA Protocols
5. Safety and Effectiveness of Giving Indinavir Plus Stavudine Plus Lamivudine to HIV-Infected Children
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A Study of Different Doses of Megestrol Acetate in Patients with AIDS Who Have Anorexia and Malnutrition
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