A Study of Different Doses of Megestrol Acetate in Patients With AIDS Who Have Anorexia and Malnutrition

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00002300
First received: November 2, 1999
Last updated: October 1, 2007
Last verified: October 2007
  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 2

Study Type: Interventional
Study Design: Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 NS Tchekmedyian
Long Beach, California, United States, 90801
Dr Stephen J Gabin Jr
Los Angeles, California, United States, 90067
Eisenhower Med Ctr
Rancho Mirage, California, United States, 92270
United States, Colorado
Denver Public Health Dept
Denver, Colorado, United States, 80204
United States, District of Columbia
George Washington Univ Med Ctr
Washington, District of Columbia, United States, 20037
Veterans Administration Med Ctr
Washington, District of Columbia, United States, 20422
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
Albany Med College / AIDS Treatment Ctr
Albany, New York, United States, 12203
Community Research Initiative on AIDS
New York, New York, United States, 10010
Mem Sloan - Kettering Cancer Ctr
New York, New York, United States, 10021
Saint Vincent's Hosp and Med Ctr
New York, New York, United States, 10011
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

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00002300     History of Changes
Other Study ID Numbers: 025A, MEG8807
Study First Received: November 2, 1999
Last Updated: October 1, 2007
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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Anorexia
Cachexia
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Megestrol Acetate
Megestrol
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Appetite Stimulants
Central Nervous System Stimulants
Physiological Effects of Drugs
Central Nervous System Agents
Contraceptives, Oral, Synthetic

ClinicalTrials.gov processed this record on September 22, 2014