The Safety and Effectiveness of Megace in HIV-Infected Women (NCT00002345) | Clinical Trial Compass
CompletedPhase 4
The Safety and Effectiveness of Megace in HIV-Infected Women
United States40 participants
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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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 t…