NCT00002148已完成1 期
Parallel Group, Placebo-Controlled, Tolerability, Safety, and Efficacy Study of OPC-14117 in HIV Dementia
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 3
研究概览
简要总结
To assess the tolerability and safety of OPC-14117. To evaluate effects of OPC-14117 on cognitive function, quality of life, and activities of daily living.
详细描述
Patients receive OPC-14117 or placebo bid for 12 weeks, followed by 12 weeks of open label therapy.
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
- •Patients must have:
- •HIV seropositivity.
- •Cognitive impairment.
- •Prior Medication:
- •Prior OPC-14117 other than on the current study.
- •Antiretroviral therapy if stable for 6 weeks prior to study entry (12 weeks for stavudine).
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Current opportunistic CNS infection (i.e., toxoplasmosis or cryptococcal meningitis).
- •Severe pre-morbid psychiatric illness including schizophrenia and major depression that would interfere with protocol compliance.
- •CNS neoplasms.
- •Any other clinically significant condition or laboratory abnormality that would interfere with ability to participate on study.
- •Current participation in other drug studies.
- •Patients with the following prior conditions are excluded:
- •Past history of opportunistic CNS infection (i.e., toxoplasmosis or cryptococcal meningitis).
- •History of chronic neurological disorders such as serious head injury, documented stroke, multiple sclerosis, uncontrolled epilepsy, Tourette's syndrome, and other neurodegenerative processes such as Huntington's disease.
- •History of adverse reaction / allergy to OPC-
- •Prior participation on this study.
- •Prior Medication:
- •Other investigational drugs within the past 30 days. Alcoholism within past 6 months (more than 2 drinks daily).
研究者
研究点 (3)
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