Phase I/II Study of ABT-378/Ritonavir in Combination With Reverse Transcriptase Inhibitors in Antiretroviral Naive HIV-Infected Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 100
- 试验地点
- 10
- 主要终点
- Proportion of subjects with viral load below the limit of quantitation
研究概览
简要总结
To assess the safety, tolerability and antiviral activity of lopinavir/ritonavir when administered orally in antiretroviral-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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
Group 1, n=32 initiated with ABT-378 & ritonavir; after 3 wks stavudine and lamivudine was added.
干预措施: Lopinavir/Ritonavir (Drug)
1
Group 1, n=32 initiated with ABT-378 & ritonavir; after 3 wks stavudine and lamivudine was added.
干预措施: Lamivudine (Drug)
1
Group 1, n=32 initiated with ABT-378 & ritonavir; after 3 wks stavudine and lamivudine was added.
干预措施: Stavudine (Drug)
2
Group II patients (n=68) to be randomized after all Group I patients are enrolled and safety analysis is completed.
干预措施: Lopinavir/Ritonavir (Drug)
2
Group II patients (n=68) to be randomized after all Group I patients are enrolled and safety analysis is completed.
干预措施: Lamivudine (Drug)
2
Group II patients (n=68) to be randomized after all Group I patients are enrolled and safety analysis is completed.
干预措施: Stavudine (Drug)
结局指标
主要结局
Proportion of subjects with viral load below the limit of quantitation
时间窗: 24 weeks
Time to loss of virologic response
时间窗: 48 weeks
次要结局
- Proportion of subjects with viral load below the limit of quantitation at each visit(At each visit)