Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

The Safety and Effectiveness of Megace in HIV-Infected Women

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

November 2, 1999
October 1, 2007
Not Provided
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00002345 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
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.

Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Primary Purpose: Treatment
  • Anorexia
  • Cachexia
  • HIV Infections
Drug: Megestrol acetate
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Not Provided
Not Provided

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:


  • 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:


  • 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:


  • 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.
18 Years and older
Contact information is only displayed when the study is recruiting subjects
United States
025C, MEG169-93.007
Not Provided
Not Provided
Bristol-Myers Squibb
Not Provided
Not Provided
Bristol-Myers Squibb
October 2007

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