Efficacy Study of Substitution of Darunavir/Ritonavir (DRV/r) for Dual-boosted Protease Inhibitors (DVD)
2017年7月18日 更新者:Community Research Initiative of New England
A Randomized, Controlled Trial to Evaluate the Efficacy of Substituting Darunavir/Ritonavir (DRV/r) for Dual-boosted Protease Inhibitors in Individuals With Virologic Suppression for at Least 12 Weeks
This study will evaluate patients who have achieved virologic suppression (< 400 copies/mL) on any dual protease inhibitor (PI) combination, to determine whether patients can substitute both PIs with the single boosted PI darunavir given 600/100 ritonavir (RTV) twice daily (BID) and maintain comparable virologic suppression (% < 50 c/mL) for 24 weeks.
研究概览
详细说明
The purpose of this study is to determine if patients who have achieved virologic suppression (< 400 copies/mL) on any dual PI combination, can substitute both PIs with the single boosted PI darunavir given 600/100 rtv bid and maintain comparable virologic suppression (% < 50 c/mL) for 24 weeks.
Randomized, non-blinded, multicenter, 48 week, controlled trial to assess the non-inferiority of substituting DRV/r for a dual boosted PI combination in patients with stable virologic suppression on a regimen containing a dual boosted PI combination plus at least one additional FDA-licensed antiretroviral agent from another class.
Participants will be randomized (1:1) to one of the included treatment arms.
研究类型
介入性
注册 (实际的)
24
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
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Arizona
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Phoenix、Arizona、美国、85012
- Spectrum Medical Group
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California
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Los Angeles、California、美国、02319
- AIDS Healthcare Foundation
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Florida
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Orlando、Florida、美国
- Orlando Immunology Center
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Massachusetts
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Boston、Massachusetts、美国、02215
- Community Research Initiative of New England
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New York
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Albany、New York、美国、12208
- Albany Medical Center
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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:
- Age 18 years or older
- Treatment with a stable antiretroviral regimen containing two protease inhibitors, one additional FDA-licensed agent from another class (except NNRTIs) and a boosting dosage of ritonavir (100 BID or QD) for at least 12 weeks prior to screening
- No plans to make any changes in HIV treatment regimen (other than those required by study) in the next 48 weeks.
- HIV-1 RNA < 400 copies/ml based on the most recent value done as part of routine care at least 12 weeks prior to screening; and < 400 at screening
- Any CD4 count is allowed
- Written informed consent to participate
Exclusion Criteria:
- Current regimen includes an NNRTI
- CDC Class C Illness diagnosed within 30 days of screening
- Lab abnormalities as defined by a standardized grading scheme based on the DAIDS table
Any grade 3 or 4 toxicity with the following exceptions:
- Pre-existing diabetes with glucose elevations ≥ grade 3
- triglyceride or total cholesterol elevations ≥ grade 3
- Clinical or laboratory evidence of clinically significant liver impairment/dysfunction, disease or cirrhosis Note: Individuals co-infected with chronic hepatitis B or C will be allowed to enter the trial if their condition is clinically stable. Individuals diagnosed with acute viral hepatitis at screening will not be allowed to enroll during acute phase.
- Active substance abuse or significant psychiatric illness that in the opinion of the investigator might interfere with study compliance.
- Use of any investigational agents 30 days prior to screening
- Life expectancy < 6 months in the opinion of the investigator
- Prior use of darunavir or known allergy to any of the components of darunavir
- Breast feeding
- Female subject of childbearing potential not using effective non-hormonal birth control methods or not willing to continue practicing these birth control methods from screening until the last trial related activity.
Note: Hormonal based contraception may not be reliable when taking darunavir, therefore to be eligible for this study, women of childbearing potential who may have vaginal intercourse should either:
- Use a double barrier method to prevent pregnancy (i.e., using a condom with either a diaphragm or cervical cap) Or
- Use hormonal based contraceptives in combination with a barrier contraceptive (i.e., male condom, diaphragm, cervical cap or female condom) Or
- Use an intra uterine device (IUD) in combination with a barrier contraceptive (i.e., male condom, diaphragm, cervical cap or female condom) Or
- Be non-heterosexually active, practice sexual abstinence or have a vasectomized partner (confirmed sterile).
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 |
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有源比较器:Switch to DRV/r
Switch to DRV/r at a dose of 600/100 BID for 48 weeks
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Switch to DRV/r at a dose of 600/100 BID for 48 weeks
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有源比较器:Continue on Current Dual Boosted PI
Continue on current dual boosted PI until week 24.
At week 24, participants will be allowed to cross over to the DRV/r arm provided that they have maintained virologic suppression (< 400 copies/ml) for the first 24-weeks of the study and are followed for an additional 24 weeks
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Continue on current dual boosted PI until week 24.
At week 24, participants will be allowed to cross over to the DRV/r arm provided that they have maintained virologic suppression (< 400 copies/ml) for the first 24-weeks of the study and be followed for an additional 24 weeks
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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 |
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The Percentage of Participants With Successful Virologic Suppression
大体时间:24 weeks
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Amount of HIV RNA copies per ml blood collected from subjects as measured by the Ultra-sensitive HIV-1 PCR (Roche Cobas).
Successful virologic suppression is defined as < 50 copies/ml blood.
The result is the percentage of participants with successful virologic suppression.
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24 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Economic Impact of a Substitution of Dual Boosted PIs With DRV/r
大体时间:48 weeks
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To assess the economic impact of DRV/r substitution for dual boosted PIs, we compared the average wholesale acquisition costs for the drugs in US Dollars ($) per month.
The wholesale acquisition cost in US dollars ($) for each ART regimen was determined and the difference between the cost for the experimental and control groups was calculated and reported as US dollar savings per month.
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48 weeks
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Lipid Fraction Results, Mean of the Change From Baseline to Week 24.
大体时间:baseline and 24 weeks
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We collected fasting total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides from all participants in both arms of the study.
We calculated the differences between the values at week 24 and baseline for the participants in both arms.
We reported the mean of the change from baseline to week 24.
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baseline and 24 weeks
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Treatment Satisfaction (+3, Much More Satisfied Now to -3, Much Less Satisfied Now)
大体时间:24 weeks
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Participants in the experimental arm completed treatment satisfaction questionnaires at 24 weeks, and the control arm at 48 weeks (24 weeks after mid-study crossover to boosted darunavir).
The questionnaires used numeric satisfaction scales (+3 much more satisfied now to -3 much less satisfied now).
We reported the median and ranges for each question for each study arm.
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24 weeks
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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。
调查人员
- 首席研究员:Calvin J Cohen, MD, MSc、CRI
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。
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
2007年10月1日
初级完成 (实际的)
2010年2月1日
研究完成 (实际的)
2010年2月1日
研究注册日期
首次提交
2007年10月11日
首先提交符合 QC 标准的
2007年10月11日
首次发布 (估计)
2007年10月12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
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.
艾滋病毒感染的临床试验
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Hospital Clinic of Barcelona完全的
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Rajavithi Hospital未知研究在放疗前和放疗最后一周接受放疗的 HIV 癌症患者的免疫状态 | 研究在放疗前和放疗最后一周接受放疗的 HIV 癌症患者的 HIV 病毒载量泰国
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National Institute of Allergy and Infectious Diseases...完全的HIV-1 感染 | HIV抗体 | 中和抗体 | 病毒载量 | 单克隆抗体美国
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AIDS Healthcare FoundationUniversity of California, Los Angeles完全的
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ANRS, Emerging Infectious DiseasesInstitut National de la Santé Et de la Recherche Médicale, France; University of Bergen; Centre... 和其他合作者完全的
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Hospital Universitari Vall d'Hebron Research InstituteGilead Sciences完全的
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Hospital Universitari Vall d'Hebron Research InstituteUniversity Hospital, Ghent; IrsiCaixa完全的
Darunavir (DRV/r)的临床试验
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PENTA FoundationBaylor College of Medicine; Institut National de la Santé Et de la Recherche Médicale, France; Centre Mère et Enfant de la Fondation Chantal Biya 和其他合作者尚未招聘
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PENTA FoundationInstitut National de la Santé Et de la Recherche Médicale, France; MRC CTU at UCL; PHPT完全的
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Tibotec Pharmaceuticals, Ireland完全的
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ASST Fatebenefratelli SaccoElisa Colella, M.D.; Valentina Di Cristo, M.D.; Massimo Galli, M.D.完全的
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Gilead Sciences完全的艾滋病毒感染 | 获得性免疫缺陷综合症 | HIV-1美国, 加拿大
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Willem Daniel Francois VenterMedical Research Council, South Africa完全的
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University of California, Los AngelesNational Institute of Allergy and Infectious Diseases (NIAID)完全的
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Janssen Research & Development, LLC完全的