Anorexia, Cachexia, HIV Infections
Conditions
Keywords
Megestrol, Acquired Immunodeficiency Syndrome, Anorexia, Cachexia, Suspensions
Brief 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.
Detailed description
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.
Interventions
DRUGMegestrol acetate
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed