NCT00002300已完成2 期
Phase II-III Randomized Double-Blind Study Comparing Megestrol Acetate at 100, 400, and 800 mg/Day, and Placebo in AIDS Patients With Anorexia and Cachexia
Bristol-Myers Squibb15 个研究点 分布在 1 个国家开始时间: 2001年8月31日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 试验地点
- 15
研究概览
简要总结
To compare the effects of megestrol acetate and placebo on body weight, anorexia, cachexia, calorie intake, and nutritional parameters of patients with a confirmed diagnosis of AIDS. To characterize dose response in relation to weight gain. To determine whether megestrol acetate relative to placebo improves the perception of well-being among AIDS patients with cachexia. To evaluate megestrol acetate's effect on immune function via skin test reactivity, T4/T8 ratio, and total lymphocytes.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must have:
- •Confirmed diagnosis of AIDS (CDC definition).
- •Documented weight loss or anorexia.
- •Life expectancy = or > 20 weeks.
- •The perception that the weight loss is a detriment to their well-being.
- •Ability to provide informed consent, read and write English.
- •Prior Medication:
- •Ganciclovir.
排除标准
- •Co-existing Condition:
- •Patients with the following are excluded:
- •Dementia or evidence of mental incompetence which would preclude compliance with the protocol.
- •Diarrhea defined as 5 or more watery stools per day for at least 7 days.
- •Active uncontrolled systemic infections at the start of treatment.
- •(Patients may not be entered for at least 2 weeks after acute infection.) Clinical or radiologic evidence of ascites or pleural effusions.
- •Concurrent Medication:
- •Therapy designed to treat the underlying HIV infection or which may have a major impact on appetite and/or weight gain.
- •Patients who have been started on zidovudine (AZT) within eight weeks. (Patients may have been previously treated with AZT and failed or may currently be receiving AZT for at least 8 weeks.)
- •Patients with the following are excluded:
- •Obstruction to food intake or impaired digestive/absorptive functions.
- •Contraindications to high-dose megestrol acetate (poorly controlled hypertension or heart failure or deep vein thrombosis).
- •Inability to consent or be available for close follow-up.
- •Active systemic infections at the start of treatment.
- •Patients may not be started on any therapy designed to treat the underlying HIV infection or which may have a major impact on appetite and/or weight gain.
- •Clinical or radiologic evidence of ascites or pleural effusions.
- •Patients may not be started on any therapy designed to treat the underlying HIV infection or which may have a major impact on appetite and/or weight gain.
- •Patients who have been hospitalized or have suffered an exacerbation of their illness associated with weight loss within the past 2 weeks are excluded.
- •Menstruating female patients are excluded.
- •Prior Medication:
- •Corticosteroids.
- •Anabolic steroids.
- •Marijuana.
- •Megestrol acetate.
- •Patients who have been started on zidovudine (AZT) within 8 weeks. (Patients may have been previously treated with AZT and failed or may currently be receiving AZT for at least 8 weeks.) History of substance abuse and questionable current and future abstinence.
研究者
研究点 (15)
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