NCT00002154已完成2 期
Parallel Group, Placebo-Controlled, Tolerability and Safety Study of Thioctic Acid and Deprenyl in HIV Dementia
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 3
研究概览
简要总结
The purpose of this study is to see if it is safe and effective to give thioctic acid and deprenyl (selegiline hydrochloride), alone or in combination, to HIV-infected patients who have mild to moderate dementia (a decline in their mental abilities).
详细描述
Patients are randomized to receive thioctic acid alone, deprenyl alone, thioctic acid/deprenyl, or placebo alone for 10 weeks, after which all patients may receive active drug on an open-label basis. Patients must have seven clinic visits.
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
- •Concurrent Medication:
- •Antiretrovirals provided dose has been stable for at least 6 weeks prior to study entry.
- •Patients must have:
- •HIV seropositivity.
- •Mild to moderate cognitive impairment (problems with short term memory, concentration, and feeling slowed down).
- •No active opportunistic CNS infection.
- •Ability to give informed consent.
- •Prior Medication:
- •Prior antiretrovirals provided dose has been stable for at least the past 6 weeks.
- •Prior thioctic acid or deprenyl.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Severe premorbid psychiatric illness including schizophrenia and major depression that would interfere with study compliance.
- •CNS neoplasms.
- •Any other clinically significant condition or laboratory abnormality that would preclude participation on study.
- •Current participation in other drug studies.
- •Concurrent Medication:
- •Chemotherapy for malignancy.
- •Patients with the following prior conditions are excluded:
- •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.
- •Prior participation in this study.
- •History of adverse reaction/allergy to thioctic acid or deprenyl.
- •Prior Medication:
- •Other investigational drugs within 30 days prior to study entry.
研究者
研究点 (3)
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