Pharmacokinetics of and Rate of HIV-1 RNA Decline in ARV-naive HIV-1 Infected Patients Treated With Low- or Standard-dose Saquinavir HGC (Invirase®) and Lopinavir/Ritonavir (Kaletra®
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- study the pharmacokinetics of low dose and standard dose lopinavir/ritonavir and saquinavir HGC in ARV naive HIV-1 infected Thai patients
研究概览
简要总结
Treatment with only protease inhibitors might benefit HIV patients. Laboratory data have shown that the combination of saquinavir with lopinavir and ritonavir may a good regimen. This study will explore this idea.
详细描述
Treatment with only protease inhibitors might benefit HIV patients, who experience problems with the other antiretrovirals drugs classes. Another reason to only use protease inhibitors is that the remaining classes are spared. This leaves the option to use these classes in the future, for instance in cases of drug resistance. Laboratory data have shown that the combination of saquinavir with lopinavir and ritonavir may a good regimen. This study will explore this idea.
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
- •written informed consent
- •HIV-1 infected Thai male or female > 18 years old
- •Documented positive test for HIV-1 infection
排除标准
- •Inability to understand the nature and extent of the study and the procedures required.
- •Pregnancy or lactating
- •Active opportunistic infection
- •ALT/ AST more than 2x upper limit
- •creatinine more than 1.5 time the upper limit
- •Smoke cigarettes more than 10 cigarettes a day.
- •Drink alcohol more than 2 units a day
- •Relevant history or current condition, illness that might interfere with drug absorption, distribution, metabolism or excretion.
- •Use of concomitant medication that may interfere with the pharmacokinetics of lopinavir/ritonavir or saquinavir
研究组 & 干预措施
1
different dose per arm
干预措施: Saquinavir, lopinavir, ritonavir (Drug)
2
different dose per arm
干预措施: Saquinavir, lopinavir, ritonavir (Drug)
3
different dose per arm
干预措施: Saquinavir, lopinavir, ritonavir (Drug)
4
different dose per arm
干预措施: Saquinavir, lopinavir, ritonavir (Drug)
结局指标
主要结局
study the pharmacokinetics of low dose and standard dose lopinavir/ritonavir and saquinavir HGC in ARV naive HIV-1 infected Thai patients
时间窗: 1 year
次要结局
- To describe short-term tolerability, toxicity and efficacy of combinations of low-dose and standard dose lopinavir/ritonavir and saquinavirHGC given to the patients in this trial(1 year)