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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002300
First Posted: August 31, 2001
Last Update Posted: October 2, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bristol-Myers Squibb
November 2, 1999
August 31, 2001
October 2, 2007
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Complete list of historical versions of study NCT00002300 on ClinicalTrials.gov Archive Site
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A Study of Different Doses of Megestrol Acetate in Patients With AIDS Who Have Anorexia and Malnutrition
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
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.
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Interventional
Phase 2
Masking: Double
Primary Purpose: Treatment
  • Anorexia
  • Cachexia
  • HIV Infections
Drug: Megestrol acetate
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Strang P. The effect of megestrol acetate on anorexia, weight loss and cachexia in cancer and AIDS patients (review). Anticancer Res. 1997 Jan-Feb;17(1B):657-62. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00002300
025A
MEG8807
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Bristol-Myers Squibb
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Bristol-Myers Squibb
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP