NCT00002345已完成4 期
Phase IV Study on the Safety and Efficacy of Megace Oral Suspension in HIV-Positive Females
Bristol-Myers Squibb4 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2001年8月31日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 4
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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:
- •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.
排除标准
- •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:
- •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:
- •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.
研究者
研究点 (4)
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