The Safety and Effectiveness of Megace in HIV-Infected Women

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase IV Study on the Safety and Efficacy of Megace Oral Suspension in HIV-Positive Females

Conditions
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Anorexia, Cachexia, HIV Infections

Intervention / Treatment
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* Drug: Megestrol acetate


Participation Criteria
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Eligibility Criteria
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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 the past 2 months. Megestrol acetate within the past 3 months. IV drug abuse not treated for at least 4 months.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Megestrol acetate|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Megestrol, Acquired Immunodeficiency Syndrome, Anorexia, Cachexia, Suspensions