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

October 1, 2007 updated by: Bristol-Myers Squibb

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

October 2, 2007

Last Update Submitted That Met QC Criteria

October 1, 2007

Last Verified

October 1, 2007

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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