The Safety and Effectiveness of Megace in HIV-Infected Women

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Megestrol; Megestrol Acetate

Criteria

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.