NCT01189695已完成4 期
A Randomized Controlled Study Compares the 48 Weeks Results of HIV-1 RNA Between Ritonavir-boosted Lopinavir Monotherapy and Ritonavir-boosted Lopinavir + Optimized Background Regimens in HIV-1 Infected Patients Who Have HIV-1 RNA <50 Copies/ml More Than 6 Months While Receiving Salvage PI-based Regimen and Previously Failed NNRTI-based Regimen
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Time to virological failure
研究概览
简要总结
The objective of this study is to determine efficacy of ritonavir-boosted lopinavir monotherapy as a maintenance regimen in HIV-1-infected patients who previously failed Non-nucleoside reverse transcriptase inhibitors (NNRTI) based regimens and currently received salvage protease-inhibitor (PI) based regimens.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-60 years
- •documented HIV infection
- •previously failed to NNRTI-based regimens
- •no history of failing PI-based regimens
- •receiving ritonavir-boosted PI + OBRs(such as NRITs, etravirine, raltegravir)
- •having HIV-1 RNA <50 copies/ml for at least prior 6 months
排除标准
- •Pregnant or breastfeeding woman
- •HBV co-infection that had to treated with TDF, FTC or 3TC
- •had to received medications known to have potential significant drug interaction with LPV/r
- •life expectancy less than 6 months
- •serious systemic diseases such as liver cirrhosis Child-Pugh B/C, ESRD, malignancy
- •hemoglobin <8 g/dl, platelet <50,000/mm3, AST or ALT >3 ULN, estimated creatinine clearance <50 mL/min
研究组 & 干预措施
Boosted lopinavir monotherapy
Experimental
干预措施: Ritonavir-boosted lopinavir (Drug)
boosted lopinavir + optimized background regimens (OBRs)
Active Comparator
干预措施: Ritonavir-boosted lopinavir (Drug)
boosted lopinavir + optimized background regimens (OBRs)
Active Comparator
干预措施: optimized background regimens (OBRs) (Drug)
结局指标
主要结局
Time to virological failure
时间窗: 48 weeks
virological failure was defined as having two consecutive results of HIV-1 RNA \>400 copies/ml in time separated by 4 weeks
次要结局
- Proportion of patients with virological suppression(48 weeks)
- Proportion of patients with virological failure(48 week)
- Time to loss of virological response (TLOVR)(48 weeks)
- Change of CD4 cells count(48 weeks)
- Adverse events(48 weeks)
研究者
Krittaecho Siripassorn
Dr
Bamrasnaradura Infectious Diseases Institute
研究点 (1)
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