NCT00002349已完成不适用
A Pilot Study to Compare the Antiviral and Immunologic Effects of Stavudine ( d4T ) Versus Placebo in Subjects With Evidence of Recent HIV Infection.
Bristol-Myers Squibb3 个研究点 分布在 1 个国家目标入组 40 人开始时间: 1995年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 3
研究概览
简要总结
To compare the antiviral effect of stavudine ( d4T ) versus placebo in patients with evidence of recent HIV infection.
Also, to compare the immunologic effects and effects on quality of life of d4T in these patients.
详细描述
Patients receive d4T or placebo every 12 hours for 4 weeks, after which dose decreases (or placebo) every 12 hours. Treatment continues for at least 48 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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:
- •Recent HIV infection.
- •No prior antiretroviral therapy.
- •No acute opportunistic infection at study entry.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Intractable diarrhea.
- •Bilateral peripheral neuropathy.
- •Any other condition that would preclude study therapy.
- •Concurrent Medication:
- •Myelosuppressive, neurotoxic, or hepatotoxic drugs.
- •Patients with the following prior condition are excluded:
- •History of bilateral peripheral neuropathy.
- •Prior Medication:
- •Prior antiretroviral therapy.
- •Myelosuppressive, neurotoxic, or cytotoxic agents within 3 months prior to study entry.
研究者
研究点 (3)
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