NCT00002151已完成2 期
A Randomized, Double-Blind Active-Controlled, Dose-Ranging Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 24
研究概览
简要总结
To characterize the safety and efficacy of fixed doses of MDL 28,574A administered alone and in combination with zidovudine ( AZT ) in patients with asymptomatic or mildly symptomatic HIV infection. To examine the demographic effects on population pharmacokinetics and pharmacodynamics of MDL 28,574A alone and in combination with AZT.
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:
- •Prior antiretroviral agents for up to 6 months per agent.
- •Patients must have:
- •HIV infection.
- •Asymptomatic or mildly symptomatic.
- •CD4 count 301 - 500 cells/mm3.
排除标准
- •Co-existing Condition:
- •Patients with the following condition are excluded:
- •Unable or unwilling to comply with study procedures.
- •Concurrent Medication:
- •Chemoprophylactic therapy for mycobacterial infection.
- •Any nonstudy prescription medications without approval of investigator.
- •Patients with the following prior conditions are excluded:
- •History of grade 3 or 4 toxicity to <= 600 mg/day AZT.
- •History of intolerance to lactose.
- •Chronic diarrhea within 6 months prior to study entry.
- •Unexplained intermittent or chronic fever, defined as temperature >= 38.5 C for any 7 days within the 30 days prior to study entry.
- •Prior Medication:
- •Antiretroviral therapy within 2 weeks prior to study entry.
- •Prior HIV vaccines.
- •Biological response modifiers within 30 days prior to study entry.
- •Prior foscarnet.
- •Any investigational drug with a washout < 5 half-lives prior to study entry.
- •Any medications known to alter renal, hepatic, or hematologic / immunologic function (such as barbiturates, phenothiazines, cimetidine, immunomodulators, etc.) within 14 days prior to study entry.
- •Recent history of alcohol and/or drug abuse.
研究者
研究点 (24)
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