NCT00002119已完成1 期
A Phase I/II Clinical Study of WF 10 IV Solution ( TCDO ) in Patients With HIV Infection
Oxo Chemie GmbH2 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
- 1 期
- 状态
- 已完成
- 发起方
- 试验地点
- 2
研究概览
简要总结
To evaluate the clinical toxicity, safety, and MTD of WF 10 ( TCDO ) intravenous solution administered to patients with HIV infection. To evaluate the potential anti-HIV activity of TCDO.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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:
- •Aerosolized pentamidine (300 mg monthly) as prophylaxis for PCP only in patients with CD4 count <= 200 cells/mm
- •PCP prophylaxis with aerosolized pentamidine in patients with CD4 count > 200 cells/mm3, only at the discretion of the treating physician.
- •Patients must have:
- •HIV positivity.
- •Absolute CD4 count of 150 - 500 cells/mm
- •At least 6 months of prior zidovudine therapy.
- •No active opportunistic infection requiring ongoing therapy.
- •Life expectancy of at least 6 months.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Neoplasm other than basal cell carcinoma of the skin.
- •Clinically significant cardiac disease.
- •Abnormal neurological status by a standardized assessment including strength, reflex testing, and sensory testing.
- •Unwilling to comply with protocol requirements.
- •Patients with the following prior conditions are excluded:
- •History of myocardial infarction or arrhythmias.
- •Prior Medication:
- •Excluded within 2 weeks prior to study entry:
- •Antiretroviral agent or interferon.
- •Systemic biologic response modifiers, corticosteroids, cytotoxic chemotherapeutic agents, or other drugs that can cause neutropenia or significant nephrotoxicity.
- •Rifampin or rifampin derivatives.
- •Systemic anti-infectives.
- •At least 6 months of prior zidovudine. Active drug or alcohol abuse.
研究者
研究点 (2)
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