An Open-Label, Randomized Study Evaluating a Switch From a Regimen of Two Nucleoside Reverse Transcriptase Inhibitors Regimen Plus Any Third Agent to Either a Regimen of Atazanavir/Ritonavir Once Daily and Raltegravir Twice Daily or to a Regimen of Atazanavir/Ritonavir Once Daily and Tenofovir/Emtricitabine Once Daily in Virologically Suppressed HIV-1 Infected Subjects With Safety and/or Tolerability Issues on Their Present Treatment Regimen.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 132
- 试验地点
- 9
- 主要终点
- Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 24
研究概览
简要总结
The purpose of this study is to determine whether HIV-1-infected patients, who are virologically suppressed on a regimen of 2 nucleoside reverse transcriptase inhibitors plus any third agent but are experiencing safety and/or tolerability issues, will maintain virologic suppression after switching to a regimen of heat-stable ritonavir boosted atazanavir, 300/100 mg, once daily plus raltegravir, 400 mg, twice daily.
详细描述
Allocation: Randomized nonstratified
Intervention model: Parallel versus comparator
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Atazanavir/Ritonavir + Raltegravir
Atazanavir + Ritonavir (heat-stable) + Raltegravir
干预措施: Atazanavir (Drug)
Atazanavir/Ritonavir + Raltegravir
Atazanavir + Ritonavir (heat-stable) + Raltegravir
干预措施: Ritonavir (heat-stable) (Drug)
Atazanavir/Ritonavir + Raltegravir
Atazanavir + Ritonavir (heat-stable) + Raltegravir
干预措施: Raltegravir (Drug)
Atazanavir/Ritonavir + Tenofovir/Emtricitabine
Reference
Atazanavir + Ritonavir (heat-stable) + Tenofovir/Emtricitabine
干预措施: Atazanavir (Drug)
Atazanavir/Ritonavir + Tenofovir/Emtricitabine
Reference
Atazanavir + Ritonavir (heat-stable) + Tenofovir/Emtricitabine
干预措施: Ritonavir (heat-stable) (Drug)
Atazanavir/Ritonavir + Tenofovir/Emtricitabine
Reference
Atazanavir + Ritonavir (heat-stable) + Tenofovir/Emtricitabine
干预措施: Tenofovir/Emtricitabine (Drug)
结局指标
主要结局
Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 24
时间窗: From Day 1 to Week 24
HIV-1 RNA level was measured with the Abbott m2000rt® polymerase chain reaction assay. Response rates were assessed using an intent-to-treat algorithm, with numerator representing patients meeting the response criteria, and denominator representing all randomized patients. Randomized patients not meeting the criteria for treatment failure (eg, discontinuation of study therapy or virologic rebound at or before Week 24) were considered responders. Virologic rebound was defined as 2 consecutive on-treatment HIV-1 RNA levels ≥40 c/mL or the last on-treatment HIV-1 RNA level ≥40 c/mL followed by discontinuation. Patients who experienced treatment failure or had missing Week 24 HIV-1 RNA levels were considered failures. RNA=ribonucleic acid; HIV=human immunodeficiency virus.
次要结局
- Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 24(Day 1 to Week 24)
- Number of Patients With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Treatment-emergent Adverse Events (AEs) Leading to Discontinuation, and Treatment-emergent AEs(Day 1 to Week 48)
- Mean Changes in Fasting Lipid Levels From Baseline to Week 48(From Baseline to Week 48)
- Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 48(From Day 1 to Week 48)
- Number of Participants With Virologic Rebound at Weeks 24 and 48(Day 1 to Weeks 28 and 48)
- Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 48(Day 1 to Week 48)