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A Study of Different Doses of Megestrol Acetate in Patients With AIDS Who Have Anorexia and Malnutrition
This study has been completed.
Sponsored by: Bristol-Myers Squibb
Information provided by: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00002300
  Purpose

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.


Condition Intervention Phase
Anorexia
Cachexia
HIV Infections
Drug: Megestrol acetate
Phase II

MedlinePlus related topics: AIDS
Drug Information available for: Megestrol acetate Megestrol
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Double-Blind
Official Title: 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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002300

Locations
United States, Alabama
Birmingham Veterans Administration Med Ctr / Univ of Alabama
Birmingham, Alabama, United States, 35233
United States, California
Dr Stephen J Gabin Jr
Los Angeles, California, United States, 90067
Eisenhower Med Ctr
Rancho Mirage, California, United States, 92270
Dr NS Tchekmedyian
Long Beach, California, United States, 90801
United States, Colorado
Denver Public Health Dept
Denver, Colorado, United States, 80204
United States, District of Columbia
Veterans Administration Med Ctr
Washington, District of Columbia, United States, 20422
George Washington Univ Med Ctr
Washington, District of Columbia, United States, 20037
United States, Florida
Miami Veterans Administration Med Ctr
Miami, Florida, United States, 33125
United States, Illinois
Northwestern Univ Med School
Chicago, Illinois, United States, 60611
United States, New York
Saint Vincent's Hosp and Med Ctr
New York, New York, United States, 10011
Community Research Initiative on AIDS
New York, New York, United States, 10010
Albany Med College / AIDS Treatment Ctr
Albany, New York, United States, 12203
Mem Sloan - Kettering Cancer Ctr
New York, New York, United States, 10021
United States, Pennsylvania
Univ of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Audie L Murphy Veterans Administration Hosp
San Antonio, Texas, United States, 78284
Sponsors and Collaborators
Bristol-Myers Squibb
  More Information

BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

Publications:
Study ID Numbers: 025A, MEG8807
Study First Received: November 2, 1999
Last Updated: October 1, 2007
ClinicalTrials.gov Identifier: NCT00002300  
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
T-Lymphocytes
Megestrol
Dose-Response Relationship, Drug
Acquired Immunodeficiency Syndrome
Anorexia
Cachexia

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
Signs and Symptoms, Digestive
Acquired Immunodeficiency Syndrome
Cachexia
Emaciation
Megestrol
Immunologic Deficiency Syndromes
Body Weight
Virus Diseases
Signs and Symptoms
Malnutrition
HIV Infections
Weight Loss
Sexually Transmitted Diseases
Body Weight Changes
Anorexia
Retroviridae Infections
Megestrol Acetate

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Antineoplastic Agents, Hormonal
Contraceptive Agents
Antineoplastic Agents
Contraceptives, Oral
Physiological Effects of Drugs
Contraceptive Agents, Female
Central Nervous System Stimulants
Reproductive Control Agents
Infection
Pharmacologic Actions
Therapeutic Uses
Lentivirus Infections
Contraceptives, Oral, Synthetic
Central Nervous System Agents
Appetite Stimulants

ClinicalTrials.gov processed this record on January 16, 2009