NCT00002352已完成不适用
Pilot Study of the Antiviral Activity of Multiple Doses of Oral Lobucavir in AIDS Patients
Bristol-Myers Squibb3 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2001年8月31日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 3
研究概览
简要总结
The purpose of this study is to see if lobucavir is a safe and effective treatment for cytomegalovirus in patients with AIDS.
详细描述
Patients receive 1 of 2 doses of lobucavir for 28 days, with 2 weeks of follow-up. Weekly clinic visits are required.
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.
- •TMP / SMX.
- •Isoniazid.
- •Fluconazole.
- •Ketoconazole.
- •Rifabutin.
- •Fluoxetine HCl.
- •Acetaminophen.
- •Antacids.
- •Metamucil.
- •Multivitamins.
- •Other drugs with approval from sponsor.
- •Patients must have:
- •CD4 count < 200 cells/mm
- •Cytomegalovirus ( CMV ) viruria and virosemenia.
- •No evidence of intraocular CMV.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Acute or chronic cardiovascular, pulmonary, renal, hepatic, pancreatic, hematologic, endocrine, neurological, or other unstable illness.
- •Inability to take oral medication.
- •Allergy to nucleoside analogs.
- •Diarrheal illness.
- •Poor venous access.
- •Positive test for drugs of abuse.
- •Any other condition that would render patient unsuitable for study.
- •Patients with the following prior conditions are excluded:
- •History of pancreatitis.
- •Recent diarrheal illness.
- •History of weight loss.
- •Acute serious illness within 4 weeks prior to study entry.
- •Prior Medication:
- •Excluded within 4 weeks prior to study entry:
- •Erythropoietin.
- •Any agent with anti-CMV activity.
- •Other investigational agents.
- •Prior Treatment:
- •Excluded within 4 weeks prior to study entry:
- •Blood transfusion. Drug abuse.
研究者
研究点 (3)
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