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.

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.