NCT00094367已完成3 期
See Detailed Description
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 900
- 试验地点
- 179
- 主要终点
- The occurrence of treatment-limiting adverse events after starting study drugs.
研究概览
简要总结
This study was designed to evaluate if subjects who took 600 mg of abacavir and 300 mg of lamivudine once-daily as a single tablet were just as likely to have adverse events compared to subjects who took 300 mg of abacavir and 150 mg of lamivudine administered as separate tablets twice-daily.
详细描述
A phase IIIB randomized, open-label, multicenter, parallel-arm study to evaluate the short-term safety and tolerability of the abacavir/lamivudine fixed-dose combination tablet administered once-daily or the separate abacavir and lamivudine tablets administered twice-daily, as part of a three or four-drug regimen, in antiretroviral naive HIV-1 infected subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Have HIV-1 infection.
- •Had not received any prior HIV treatment for more than 14 days.
- •At least 1000 copies of HIV-1 RNA.
- •Willing to provide signed informed consent.
排除标准
- •Enrolled in other investigational drug studies.
- •Female subjects who are pregnant or breastfeeding.
- •History of allergy or hypersensitivity to abacavir or lamivudine.
- •Certain medical conditions that would make subjects ineligible.
结局指标
主要结局
The occurrence of treatment-limiting adverse events after starting study drugs.
次要结局
- occurrence of abacavir HSR
- completion of educational training
- subject satisfaction with treatment
- adherence to study medications
- change in HIV-1 RNA from BL
- change in CD4 measure from BL.
研究者
研究点 (179)
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