NCT00135395已完成3 期
A Phase IIIb, Open -Label, Randomized Multi-center Study Comparing the Antiviral Efficacy, Safety, and Effect on Serum Lipids of Atazanavir/Ritonavir Versus Lopinavir/Ritonavir, in Combination With Two Nucleoside or Nucleotide Reverse Transcriptase Inhibitors (NRTIs) in HIV-1 Infected Subjects Experiencing Their First Virologic Failure While Receiving a NNRTI-containing HAART Regimen.
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2004年5月最近更新:
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
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Co-Primary Outcomes in this study 1)Viral load reduction from baseline through Week 24 2)Change in lipids from baseline at Week 12
研究概览
简要总结
The purpose of this study is to compare the anti-HIV efficacy, safety and effect of serum lipids of two boosted protease inhibitor-based HAART regimens (ARV/RTV v. LPV/RTV) in HIV-1 infected subjects who have experienced their first virologic failure while receiving a NNRTI-containing HAART regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •Patients ≥ 18 years of age infected with HIV
- •Plasma HIV RNA ≥ 1000 copies/mL and CD4 cell count ≥ 50 cells/mm3
- •Currently receiving a NNRTI-containing HAART regimen or not currently receiving a NNRTI-containing HAART regimen and have not been treated with an alternative regimen since the documented virologic failure (with genotype performed within 2 weeks of the discontinuation of the failing regimen and the genotype report is available)
- •The failing NNRTI-containing regimen must be the patient's first virologic failure on treatment and contain a NNRTI and at least 2 NRTIs. The regimen must have been administered for at least 24 weeks and the patient must have documented virologic response to the regimen (HIV RNA < 400 c/mL)
排除标准
- •Pregnancy or breastfeeding
- •Reported virologic failure to two or more antiretroviral regimens
- •Active AIDS-defined opportunistic infection or disease
- •Proven or suspected acute hepatitis within 30 days prior to study entry
研究组 & 干预措施
A
Active Comparator
干预措施: Atazanavir+ritonavir (Drug)
B
Active Comparator
干预措施: Lopinavir+ritonavir (Drug)
结局指标
主要结局
Co-Primary Outcomes in this study 1)Viral load reduction from baseline through Week 24 2)Change in lipids from baseline at Week 12
次要结局
- Viral load reduction from baseline at Weeks 48,72,96;Subjects with HIV RNA<50 and <400 c/mL at Weeks 24,48,72 & 96;Patterns of resistance;Safety and tolerability through Week 96 including fasting lipid values;Adherence at Weeks 4,12,24,48,72 & 96.
研究者
研究点 (1)
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