The Safety and Effectiveness of Megace in HIV-Infected Women

Completed · Phase 4

Conditions studied: Anorexia, Cachexia, HIV Infections

In brief

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.

Key facts

Study ID

NCT00002345

Run by

Bristol-Myers Squibb

People needed

40

Last updated by the study team

2007-10-02

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Univ of California - Davis Med Ctr / CARES — Sacramento, California, United States
• Yale Univ Med School — New Haven, Connecticut, United States
• Georgetown Univ Med Ctr — Washington D.C., District of Columbia, United States
• Miriam Hosp — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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