The Safety and Effectiveness of Megace in HIV-Infected Women

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00002345
First received: November 2, 1999
Last updated: October 1, 2007
Last verified: October 2007

November 2, 1999
October 1, 2007
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Complete list of historical versions of study NCT00002345 on ClinicalTrials.gov Archive Site
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The Safety and Effectiveness of Megace in HIV-Infected Women
Phase IV Study on the Safety and Efficacy of Megace Oral Suspension in HIV-Positive Females

To further evaluate the safety of megestrol acetate (Megace) oral suspension in the treatment of anorexia and cachexia in HIV-positive women. To compare the effectiveness of 2 doses of Megace by measurement of weight gain, appetite grade, and other parameters at 12 and 24 weeks.

Patients are randomized to receive 1 of 2 doses of Megace oral suspension daily for 24 weeks; at 12 weeks, those receiving the lower dose who have not gained 5 pounds over baseline or had appetite improvement to good or excellent are escalated to the higher dose. Patients are evaluated at 4-week intervals. Dose may be adjusted to maintain a desired weight.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Primary Purpose: Treatment
  • Anorexia
  • Cachexia
  • HIV Infections
Drug: Megestrol acetate
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
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Inclusion Criteria

Patient must have:

  • HIV infection.
  • Evidence of HIV wasting syndrome that includes anorexia (appetite fair or poor) and weight loss >= 10 percent of pre-illness body weight.
  • Perception of weight loss as a detriment.
  • Life expectancy of at least 24 weeks.

Prior Medication:

Allowed:

  • Megestrol acetate for weight gain at a dose < 400 mg for < 60 days, provided therapy was discontinued at least 3 months prior to study entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Poorly controlled hypertension.
  • Heart failure.
  • Deep vein thrombosis.
  • Uncontrolled severe diarrhea.
  • Treatable active current infection (excluding chronic low-grade opportunistic infections).
  • Unable to intake food.
  • Impaired digestive/absorptive function.

Concurrent Medication:

Excluded:

  • Initiation during the study of any therapy to treat HIV or anorexia/cachexia (other than study drug).

Patients with the following prior conditions are excluded:

  • Hospitalization for or exacerbation of illness associated with weight loss within the past 2 weeks.
  • Participation in other investigational drug studies within the past month.
  • Previous abnormal mammogram (if 35-40 years of age) or abnormal mammogram within the past year (if over 40 years of age).

Prior Medication:

Excluded:

  • New antiviral therapy within the past 8 weeks.
  • Medications to promote weight gain (e.g., corticosteroid, dronabinol) within the past 2 months.
  • Megestrol acetate within the past 3 months. IV drug abuse not treated for at least 4 months.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002345
025C, MEG169-93.007
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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