NCT00002410已完成3 期
A Phase III, Multicenter, Randomized, Open-Label Study to Compare Antiretroviral Activity and Tolerability of Three Different Combination Regimens (DMP 266 + Indinavir, DMP 266 + Zidovudine + Lamivudine, Indinavir + Zidovudine + Lamivudine) in HIV-Infected Patients
Dupont Merck79 个研究点 分布在 2 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
- 3 期
- 状态
- 已完成
- 发起方
- 试验地点
- 79
研究概览
简要总结
The purpose of this study is to compare the safety and effectiveness of three anti-HIV drug combinations. The three combinations are: (1) efavirenz (DMP 266) plus indinavir; (2) DMP 266 plus zidovudine (ZDV) plus lamivudine (3TC); and (3) indinavir plus ZDV plus 3TC. This study also examines the resistance HIV may have to these drugs and if these drugs are effective over a long period of time.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 13 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Exclusion Criteria
- •Concurrent Medication:
- •Terfenadine, astemizole, cisapride, triazolam, or midazolam (competition for the enzyme cytochrome P-450 3A4 [CYP3A4] by indinavir could result in inhibition of metabolic breakdown of these drugs and create the potential for serious and/or life threatening events [i.e., cardiac arrhythmia, prolonged sedation]).
- •Rifampin or rifabutin (prohibited because of potential drug interaction with indinavir).
- •Ketoconazole, itraconazole, and clarithromycin.
- •Concomitant systemic therapy for acute opportunistic infection or malignancy.
- •Life expectancy less than 12 months.
- •Prior Medication:
- •Prior treatment with efavirenz, 3TC, an NNRTI, or an HIV protease inhibitor.
- •Prior antiretroviral agent within 14 days of initiating study treatment.
- •Prior treatment (within 30 days of initiating study treatment) with any other experimental drug for any indication.
- •Patients must:
- •Have a diagnosis of HIV infection.
- •Have CD4 counts greater than or equal to 50 cell/mm
- •Have a life expectancy greater than or equal to 12 months.
- •Be post-pubescent.
排除标准
- 未提供
研究者
研究点 (79)
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