NCT00002155已完成不适用
A Six-Month Safety and Antiviral Study in HIV-1 Seropositive, AZT-Experienced Patients With CD4 Counts Less Than or Equal to 50 Cells/mm3 to Evaluate MK-639 Alone Versus Zidovudine (AZT) and 3TC Versus the Combination of MK-639 With AZT/3TC
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 1
研究概览
简要总结
To compare effects on CD4 counts and serum viral RNA among HIV-seropositive, zidovudine (AZT)-experienced patients in three treatment arms: indinavir sulfate ( MK-639; Crixivan ) plus AZT plus lamivudine ( 3TC ) versus MK-639 alone versus AZT/3TC.
详细描述
AZT-experienced patients are randomized to receive MK-639/AZT/3TC or MK-639 alone or AZT/3TC. Additionally, patients who have received < 6 months of AZT or who are intolerant but received prior 3TC or who require concomitant rifampin therapy may receive open-label MK-639.
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:
- •Allowed for all patients:
- •Standard prophylaxis for opportunistic infections.
- •Continuation of treatment for opportunistic infection.
- •Allowed for open-label study patients:
- •Rifampin.
- •Patients must have:
- •HIV positivity.
- •CD4 count <= 50 cells/mm
- •More than 6 months of prior AZT (blinded study only).
- •Patients on the open-label study must have AZT intolerance or have < 6 months of prior AZT.
- •Prior Medication:
- •Required for blinded study patients:
- •> 6 months of prior AZT.
- •Required for open-label study patients:
- •< 6 months of prior AZT.
- •Allowed for open-label study patients:
- •Prior 3TC.
排除标准
- •Concurrent Medication:
- •Excluded in all patients:
- •Immunosuppressants.
- •Excluded in blinded study patients:
- •AZT, ddI, ddC, or d4T.
- •Rifampin.
- •Excluded in open-label study patients:
- •Prior Medication:
- •Excluded in all patients:
- •Prior protease inhibitors.
- •Investigational agents and immunomodulators within 30 days prior to study entry.
- •Immunosuppressants within 2 weeks prior to study entry.
- •Excluded in blinded study patients:
- •Any prior 3TC.
- •AZT, ddI, ddC, or d4T within 2 weeks prior to study entry.
- •Excluded in open-label study patients:
- •3TC within 30 days prior to study entry.
研究者
研究点 (1)
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