The Safety and Effectiveness of Megace in HIV-Infected Women

Launched by BRISTOL-MYERS SQUIBB · Aug 30, 2001

Keywords

ClinConnect Summary

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.

Gender

FEMALE

Eligibility 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.