NCT00234923已完成3 期
A Pilot, Open-Label, Randomized, Comparative Study of the Antiviral Efficacy of Lopinavir/Ritonavir Single-Drug Regimen Versus Lopinavir/Ritonavir in Combination With Lamivudine/Zidovudine in Antiretroviral Naïve Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 138
- 主要终点
- Antiviral efficacy by HIV RNA
研究概览
简要总结
The purpose of this pilot study is to obtain a preliminary assessment of the antiviral activity and tolerability of Kaletra single agent therapy as initial treatment for HIV infection, relative to a Kaletra three drug standard of care reference arm
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
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
- •Antiretroviral naïve
- •HIV RNA <100,000 copies/mL
- •CD4 cell count >100 cells/mL at screening
- •with Karnofsky Score > 70
- •If female,
- •non-pregnant and
- •not breastfeeding
- •No AIDS opportunistic infection within 30 days of screening
排除标准
- •Subject with an HIV primo-infection status
- •Recent history of drug and/or alcohol abuse
- •History of psychiatric illness
- •If presence of the following mutations :
- •in the protease : one among 32,47,48,50,82,84,90
- •OR more than 3 mutations from the other points of the LPV mutation score:10,20,24,46,53,54,63,71
- •in the reverse transcriptase : 215 or
- •If abnormal laboratory results such as :
- •Hb<8 g/dl
- •Absolute neutrophil count<750 cells/µl
- •Platelet count<50 000/ml
研究组 & 干预措施
1
Active Comparator
Kaletra Monotherapy: lopinavir/ritonavir
干预措施: lopinavir/ritonavir (Drug)
2
Active Comparator
Kaletra based triple therapy: lopinavir/ritonavir + lamivudine/zidovudine
干预措施: lopinavir/ritonavir (Drug)
2
Active Comparator
Kaletra based triple therapy: lopinavir/ritonavir + lamivudine/zidovudine
干预措施: lamivudine/zidovudine (Drug)
结局指标
主要结局
Antiviral efficacy by HIV RNA
时间窗: 48 Weeks
次要结局
- Arm comparisons: CD4 evolution, occurrence of HIV protease and RT mutation, occurrence of AIDS clinical events, safety of NRTI-sparing vs. a PI with 2 NRTIs regimen: clinical and biological tolerance, patient's adherence and quality of life.(48 weeks)
- To assess in the LPV/r single-drug regimen arm: virological control, CD4 evolution, safety(96 weeks)
研究者
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