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Atazanavir/Ritonavir, Once Daily + Raltegravir, Twice Daily, Switch Study in HIV-1-Infected Patients (SPARTAN)

2015年2月2日 更新者：Bristol-Myers Squibb

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.

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.

研究概览

地位

完全的

条件

干预/治疗

详细说明

Allocation: Randomized nonstratified

Intervention model: Parallel versus comparator

研究类型

介入性

注册 (实际的)

132

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 德国
      • Bochum、德国、44791
        • Local Institution
      • Frankfurt、德国、60590
        • Local Institution
      • Frankfurt Am Main、德国、60311
        • Local Institution
      • Hamburg、德国、20246
        • Local Institution
      • Munich、德国、80336
        • Local Institution
  • 意大利
      • Genova、意大利、16128
        • Local Institution
      • Genova、意大利、16132
        • Local Institution
      • Milano、意大利、20127
        • Local Institution
      • Milano、意大利、20142
        • Local Institution
      • Roma、意大利、00149
        • Local Institution
  • 法国
      • Lyons Cedex 04、法国、69317
        • Local Institution
      • Orleans Cedex 2、法国、45067
        • Local Institution
      • Paris、法国、75020
        • Local Institution
      • Paris Cedex 14、法国、75679
        • Local Institution
      • Strasbourg Cedex、法国、67091
        • Local Institution
    • Cedex 12
      • Paris、Cedex 12、法国、75551
        • Local Institution
  • 波兰
      • Warszawa、波兰、01-201
        • Local Institution
      • Wroclaw、波兰、50-136
        • Local Institution
  • 美国
    • Arkansas
      • Little Rock、Arkansas、美国、72207
        • Health For Life Clinic Pllc
    • California
      • Palm Springs、California、美国、92264
        • Eisenhower Medical Center
      • San Francisco、California、美国、94109
        • Metropolis Medical Pc
    • Florida
      • Daytona Beach、Florida、美国、32117
        • Consultive Medicine
      • Orlando、Florida、美国、32805
        • Orange County Health Dept.
      • West Palm Beach、Florida、美国、33401
        • Triple O Medical Services, P.A.
    • Massachusetts
      • Springfield、Massachusetts、美国、01105
        • The Research Institute
    • New York
      • Rochester、New York、美国、14607
        • Aids Care
  • 英国
      • Brighton、英国、BN2 1ES
        • Local Institution
      • London、英国、E9 6SR
        • Local Institution
      • London、英国、NW3 2QG
        • Local Institution
      • Sheffield、英国、S10 2RX
        • Local Institution
    • Greater London
      • London、Greater London、英国、SW10 9EL
        • Local Institution
    • Greater Manchester
      • Manchester、Greater Manchester、英国、M8 5RB
        • Local Institution
  • 西班牙
      • Alicante、西班牙、03010
        • Local Institution
      • Barcelona、西班牙、08036
        • Local Institution
      • Madrid、西班牙、28006
        • Local Institution
      • Madrid、西班牙、28007
        • Local Institution
      • Madrid、西班牙、28046
        • Local Institution
      • Madrid、西班牙、28805
        • Local Institution

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Key Inclusion Criteria

  • Current treatment regimen of 2 nucleoside reverse transcriptase inhibitors (NRTIs) plus any third agent for at least 3 months immediately prior to screening
  • Virologic suppression (HIV-1 RNA <50 c/mL) for at least 3 months immediately prior to screening
  • Virologic suppression (HIV-1 RNA <40 c/mL) using the Abbott m2000rt® polymerase chain reaction assay during screening period
  • Treatment-related safety and/or tolerability issues to a regimen consisting of 2 NRTIs plus any third agent

Key Exclusion Criteria

  • History of switch in highly active antiretroviral therapy due to virologic failure
  • History of genotypic resistance to any component of the study regimen (atazanavir, raltegravir, tenofovir/emtricitabine)
  • History of exposure to atazanavir/ritonavir or raltegravir prior to entering the study
  • Experiencing safety and/or tolerability issues to tenofovir/emtricitabine or raltegravir
  • Switch of any component of HIV antiretroviral medication regimen in the last 3 months immediately prior to or during the screening period

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Atazanavir/Ritonavir + Raltegravir
Atazanavir + Ritonavir (heat-stable) + Raltegravir
药品：Atazanavir
Capsules, Oral, 300mg, Once daily, 48 weeks
其他名称：
  • 雷亚塔兹
药品：Ritonavir (heat-stable)
Tablets, Oral, 100 mg, Once daily, 48 weeks
其他名称：
  • 诺维尔
药品：Raltegravir
Tablets, Oral, 400 mg, Twice daily, 48 weeks
其他名称：
  • 女主播
其他：Atazanavir/Ritonavir + Tenofovir/Emtricitabine

Reference

Atazanavir + Ritonavir (heat-stable) + Tenofovir/Emtricitabine
药品：Atazanavir
Capsules, Oral, 300mg, Once daily, 48 weeks
其他名称：
  • 雷亚塔兹
药品：Ritonavir (heat-stable)
Tablets, Oral, 100 mg, Once daily, 48 weeks
其他名称：
  • 诺维尔
药品：Tenofovir/Emtricitabine
Tablets, Oral, 300/200 mg, Once daily, 48 weeks
其他名称：
  • 特鲁瓦达

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 24
大体时间：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.
From Day 1 to Week 24

次要结果测量

结果测量
措施说明
大体时间
Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 48
大体时间：From Day 1 to Week 48
Percentages of patients with HIV-1 RNA levels <40 c/mL were summarized at each scheduled visit. Longitudinal plots were created to display proportion versus visit week through Weeks 24 and 48 with error bars representing 95% confidence intervals.
From Day 1 to Week 48
Number of Participants With Virologic Rebound at Weeks 24 and 48
大体时间：Day 1 to Weeks 28 and 48
Viral genotypic and phenotypic resistance profiles were assessed for virologic rebound (HIV-1 RNA level ≥40 c/mL). Only patients with HIV-1 RNA levels ≥500 c/mL met the criteria for resistance testing. Genotypic substitutions at baseline were summarized for virologic rebound. The genotypic resistance profile presented patients with genotypable isolates, those with protease inhibitor substitutions from genotypable isolates, those with integrase substitutions from genotypable isolates, and those with selected reverse transcriptase substitutions from genotypable isolates using the most current version of the International AIDS Society-USA list and Stanford HIV Drug Resistance Database. Newly emergent genotypic substitutions were summarized analogously for virologic rebound without baseline phenotypic resistance to atazanavir, ritonavir, or raltegravir, using all on-treatment isolates.
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 24
大体时间：Day 1 to Week 24
Viral genotypic and phenotypic resistance profiles were assessed for virologic rebound (HIV-1 RNA level ≥40 c/mL). Only patients with HIV-1 RNA levels ≥500 c/mL met the criteria for resistance testing. Genotypic substitutions at baseline were summarized for virologic rebound. The genotypic resistance profile presented patients with genotypable isolates, those with protease inhibitor substitutions from genotypable isolates, those with integrase substitutions from genotypable isolates, and those with selected reverse transcriptase substitutions from genotypable isolates using the most current version of the International AIDS Society-USA list and Stanford HIV Drug Resistance Database. Newly emergent genotypic substitutions were summarized analogously for virologic rebound without baseline phenotypic resistance to atazanavir, ritonavir, or raltegravir, using all on-treatment isolates. pts=patients
Day 1 to Week 24
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
大体时间：Day 1 to Week 48
Viral genotypic and phenotypic resistance profiles were assessed for virologic rebound (HIV-1 RNA level ≥40 c/mL). Only patients with HIV-1 RNA levels ≥500 c/mL met the criteria for resistance testing. Genotypic substitutions at baseline were summarized for virologic rebound. The genotypic resistance profile presented patients with genotypable isolates, those with protease inhibitor substitutions from genotypable isolates, those with integrase substitutions from genotypable isolates, and those with selected reverse transcriptase substitutions from genotypable isolates using the most current version of the International AIDS Society-USA list and Stanford HIV Drug Resistance Database. Newly emergent genotypic substitutions were summarized analogously for virologic rebound without baseline phenotypic resistance to atazanavir, ritonavir, or raltegravir, using all on-treatment isolates. pts=patients
Day 1 to Week 48
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
大体时间：Day 1 to Week 48
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug.
Day 1 to Week 48
Mean Changes in Fasting Lipid Levels From Baseline to Week 48
大体时间：From Baseline to Week 48
LD=low-density lipoprotein; HDL=high-density lipoprotein.
From Baseline to Week 48

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Bristol-Myers Squibb

调查人员

  • 研究主任：Bristol-Mayers Squibb、Bristol-Mayers Squibb

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2011年10月1日

初级完成 (实际的)

2013年9月1日

研究完成 (实际的)

2014年2月1日

研究注册日期

首次提交

2011年4月7日

首先提交符合 QC 标准的

2011年4月8日

首次发布 (估计)

2011年4月11日

研究记录更新

最后更新发布 (估计)

2015年2月19日

上次提交的符合 QC 标准的更新

2015年2月2日

最后验证

2015年2月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • AI424-402
  • 2009-017032-41 (EudraCT编号)

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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