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BATAR: Individuals Currently Taking Boosted Atazanavir as Part of an HIV Treatment Regimen Will be Evaluated to See if Substituting Raltegravir for Nucleoside Transcriptase Inhibitors Will be Safe and Well Tolerated. (BATAR)

2017年7月18日 更新者：Community Research Initiative of New England

A Pilot Study of the Novel Antiretroviral Combination of Atazanavir and Raltegravir in HIV-1 Infected Subjects With Virologic Suppression on a Standard Regimen of Boosted Atazanavir, Tenofovir and Emtricitabine

The purpose of this Phase IV pilot study is to evaluate the safety, tolerability, and satisfaction of a nucleoside analog reverse-transcriptase inhibitors (NRTI)sparing regimen for participants fully suppressed on an atazanavir/ritonavir based highly active antiretroviral therapy (HAART)regimen plus emtricitabine/tenofovir (Truvada). Several pharmacologic factors support this concept including the favorable drug interaction between atazanavir and raltegravir. Participants will be randomized to either continue on their current regimen or one of two study arms (atazanavir 300mg plus ritonavir 100mg daily plus raltegravir 400mg twice daily or atazanavir 300mg twice daily plus raltegravir 400mg twice daily). Participants will be followed for 48 weeks for safety, tolerability, and satisfaction. After baseline, the participants will have six clinic visits for evaluation and labs.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

43

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

  • 美国
    • Arizona
      • Phoenix、Arizona、美国、85012
        • Spectrum Medical Group
    • California
      • Los Angeles、California、美国、90028
        • AIDS Healthcare Foundation
    • Colorado
      • Denver、Colorado、美国、80204
        • Denver public Health
    • District of Columbia
      • Washington, D.C.、District of Columbia、美国、20009
        • Whitman-Walker Clinic
    • Florida
      • Orlando、Florida、美国、32803
        • Orlando Immunology Center
      • Vero Beach、Florida、美国、32960
        • Treasure Coast Infectious Disease Consultants
    • Kansas
      • Wichita、Kansas、美国、67214
        • Christi Research
    • Massachusetts
      • Boston、Massachusetts、美国、02215
        • Community Research Initiative of New England - Boston
    • Texas
      • Dallas、Texas、美国、75804
        • David M. Lee, MD, PA d/b/a/ Uptown Physicians' Group

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

Inclusion Criteria:

  • HIV-1 infection
  • Treatment with a stable antiretroviral regiment containing boosted atazanavir, tenofovir and emtricitabine at screen and for at least 90 days prior to screening
  • No plan to make changes to HIV treatment regimen (other than those required by the study) in the next 48 weeks
  • Undetectable HIV RNA at screening AND no HIV RNA>200 copies during the 180 day period prior to screening
  • CD4 count>200
  • No evidence of resistance to any of the drugs in any of the 3 arms, if prior resistance tests are available
  • Subjects who, in the opinion of their treating physicians, would be candidates to switch antiretroviral medications
  • Women of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 8 weeks after the last dose of study drug
  • Ability and willingness to provide written informed consent and comply with protocol requirements

Exclusion Criteria:

  • Prior exposure to raltegravir or elvitegravir
  • Women who are pregnant, breast-feeding, or with a positive pregnancy test
  • Sexually active fertile men not using effective birth control if their female partners are of child-bearing potential
  • Women of child-bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of study drug
  • Life expectancy less than 6 months
  • Presence of any currently active AIDS defining conditions with the exception of stable cutaneous Kaposi's sarcoma
  • Treatment with proton-pump inhibitor or H2-receptor antagonist
  • ECG demonstrating atrioventricular block, prolonged QRS interval greater than 12 ms, or known complete bundle branch block
  • Acute or chronic hepatitis B infection as evidenced by presence of hepatitis B surface antigen and absence of hepatitis B surface antibody
  • Clinical or laboratory evidence of significantly decreased hepatic function of decompensation irrespective of liver enzyme levels
  • Prisoners or subjects who are involuntarily incarcerated
  • Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness

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：Intervention Arm No.1
药品：atazanavir/raltegravir
Atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily
药品：atazanavir/raltegravir
Atazanavir 300mg twice daily plus raltegravir 400mg twice daily
实验性的：Intervention Arm No.2
药品：atazanavir/raltegravir
Atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily
药品：atazanavir/raltegravir
Atazanavir 300mg twice daily plus raltegravir 400mg twice daily
有源比较器：Control Arm
Continue baseline regimen
药品：atazanavir/tenofovir/emtricitabine
Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine
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
Maintenance of Virologic Suppression
大体时间：48 weeks
To evaluate and compare maintenance of virologic suppression with raltegravir (RAL) 400mg 2x daily plus atazanavir (ATV) dosed either as ATV/ritonavir (RTV)300/100mg 1x daily or ATV 300mg 2x daily in subjects with virologic suppression on a standard regimen of ATV/RTV plus Truvada. Virologic suppression is defined as HIV RNA < 40 copies/mL.
48 weeks

次要结果测量

结果测量
措施说明
大体时间
The Difference in CD4 From Baseline to Week 48
大体时间：Baseline and Week 48
Change in mean CD4 from Baseline to Week 48.
Baseline and Week 48
The Change in Adherence to Study Treatment Arm From Baseline to Week 48
大体时间：Baseline and Week 48
Adherence to study treatment reported as the percentage of doses of the prescribed treatment arm regimen taken, described by each subject through recall of dosing in the three days prior to the visit Baseline and Week 48 vistis. The change in adherence is reflected as the difference of the mean percentage of adherence per arm between Baseline and Week 48 visits.
Baseline and Week 48
Change in Quality of Life From Baseline to 48 Weeks of Study Treatment
大体时间：baseline and 48 weeks
Quality of Life was measured by self report using a standardized scale, where 0 is death and 100 is perfect health. The baseline measure was obtained prior to initiation of study treatment arm. The week 48 measure captures Quality of Life by self report at 48 weeks of study treatment.
baseline and 48 weeks

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

Community Research Initiative of New England

合作者

Bristol-Myers Squibb
Merck Sharp & Dohme LLC

调查人员

  • 首席研究员：Calvin J Cohen, MD, MSc、Community Research Initiative

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

2009年12月1日

初级完成 (实际的)

2012年2月1日

研究完成 (实际的)

2012年3月1日

研究注册日期

首次提交

2009年6月30日

首先提交符合 QC 标准的

2009年7月1日

首次发布 (估计)

2009年7月2日

研究记录更新

最后更新发布 (实际的)

2017年7月21日

上次提交的符合 QC 标准的更新

2017年7月18日

最后验证

2017年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 09-102

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.

艾滋病病毒的临床试验

atazanavir/raltegravir的临床试验

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医疗条件

药物干预

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条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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