Study of Viral Load Decay Rates in HIV Infected Participants Starting Treatment With Raltegravir (RAL) and Emtricitabine/Tenofovir Disoproxil Fumarate (TDF)
2021年10月28日 更新者：National Institute of Allergy and Infectious Diseases (NIAID)
First-Phase Viral Decay Rates in Treatment-Naive Subjects Initiating Treatment With Raltegravir (RAL) and Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF): A Pilot Study
The HIV integrase inhibitor, raltegravir (RAL), which was recently approved by the FDA, has been shown in several trials to be highly effective.
The purpose of this trial is to estimate the viral load decay rate in treatment-naive HIV infected participants receiving RAL and emtricitabine/tenofovir disoproxil fumarate (FTC/TDF).
研究概览
详细说明
Recent data suggests that early virologic response to HIV interventions may be predictive of long-term virologic outcomes. Defining early decay in viral load through carefully performed studies of viral dynamics may be a useful tool for assessing the likely outcome of long-term treatment. It may also be a useful screening tool to define which combinations should be studied further. In this trial, the viral load decay rate will be estimated in HIV infected, treatment-naive participants receiving RAL and FTC/TDF.
This study will last approximately 72 weeks. All participants will take RAL and FTC/TDF for 72 weeks. RAL will be provided by the study. FTC/TDF will not be provided.
This study will consist of 16 study visits. These visits will occur at study entry, Days 2, 7, 10, 14, 21, 28, and 56, and Weeks 12, 16, 20, 24, 36, 48, 60, and 72. Blood collection and pharmacokinetic studies will occur at all study visits. Self-reported adherence assessments will be submitted at each visit. A targeted physical exam will occur at most visits. Liver function tests and urine collection will occur at select visits. Pregnancy tests will occur whenever pregnancy is suspected.
研究类型
介入性
注册 (实际的)
40
阶段
- 阶段1
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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California
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San Diego、California、美国、92103
- UCSD Antiviral Research Center CRS
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Colorado
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Aurora、Colorado、美国、80045
- University of Colorado Hospital CRS
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Illinois
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Chicago、Illinois、美国、60611
- Northwestern University CRS
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Maryland
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Baltimore、Maryland、美国、21205
- Johns Hopkins University CRS
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Baltimore、Maryland、美国、21201
- IHV Baltimore Treatment CRS
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Massachusetts
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Boston、Massachusetts、美国、02115
- Brigham and Women's Hospital Therapeutics Clinical Research Site (BWH TCRS) CRS
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Missouri
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Saint Louis、Missouri、美国、63110-1010
- Washington University Therapeutics (WT) CRS
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New York
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New York、New York、美国、10037
- Harlem ACTG CRS
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Rochester、New York、美国、14642
- Univ. of Rochester ACTG CRS
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Rochester、New York、美国、14607
- Trillium Health ACTG CRS
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Ohio
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Cleveland、Ohio、美国、44109
- MetroHealth CRS
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Columbus、Ohio、美国、43210
- Ohio State University CRS
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Rhode Island
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Providence、Rhode Island、美国、02906
- The Miriam Hospital Clinical Research Site (TMH CRS) CRS
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Tennessee
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Nashville、Tennessee、美国、37204
- Vanderbilt Therapeutics (VT) CRS
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Texas
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Houston、Texas、美国、77030
- Houston AIDS Research Team CRS
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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:
- HIV infected
- Antiretroviral treatment naive
- Viral load at least 10,000 and less than 300,000 copies/ml within 42 days prior to study entry
- Agree to use appropriate form of contraception. More information on this criterion can be found in the protocol.
Exclusion Criteria:
- Received HIV-specific immunizations within 6 months prior to study entry
- Received immunizations within 6 months prior to study entry
- Known allergy or sensitivity to study drugs
- Any participant with an acute AIDS-defining opportunistic infection (OI) who is not clinically stable or who has not been on therapy for the OI for at least 30 days prior to study entry
- Treatment with immune modulators or any investigational therapy within 30 days prior to study entry
- Evidence of HIV seroconversion within 6 months prior to study entry
- Illness requiring systemic treatment and/or hospitalization
- Substance abuse that, in the opinion of the investigator, would interfere with adherence to study requirements
- Requirement for any current medications that are prohibited with any study medication. More information on this criterion can be found in the protocol.
- Evidence of any major resistance-associated mutation on any genotype performed prior to study entry or at the time of screening. More information on this criterion can be found in the protocol.
- Abnormal laboratory values. More information on this criterion can be found in the protocol.
- Pregnant or breastfeeding
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：不适用
- 介入模型：单组作业
- 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：1
Oral RAL and FTC/TDF for 72 weeks
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400 mg tablet taken orally twice daily
其他名称：
Fixed dose tablet containing 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate taken once daily.
FTC/TDF will not be provided by the study and must be obtained by the particpant's health care provider.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Viral load decay rates
大体时间：Through Day 56
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Through Day 56
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Viral load decay rates
大体时间：From Weeks 24 to 72
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From Weeks 24 to 72
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Proportion of participants with a viral load less than 50 copies/ml
大体时间：At Weeks 24, 48, and 72
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At Weeks 24, 48, and 72
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Safety and tolerability. More information on this criterion can be found in the protocol.
大体时间：Throughout study
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Throughout study
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CD4 and CD8 count
大体时间：Throughout study
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Throughout study
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Resistance mutations to RAL, FTC, and TDF
大体时间：Throughout study
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Throughout study
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Minimum concentration (Cmin) for RAL, FTC, and TDF
大体时间：Throughout study
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Throughout study
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Changes in viral load
大体时间：At Day 7
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At Day 7
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Self-reported adherence
大体时间：Throughout study
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Throughout study
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Cell-associated proviral DNA, LTR circular DNA, and integrated proviral DNA
大体时间：Throughout study
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Throughout study
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Viral load
大体时间：From Week 24 to Week 72
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From Week 24 to Week 72
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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
- 学习椅：Adriana Andrade, MD, MPH、Johns Hopkins University
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。
一般刊物
- Evering TH, Markowitz M. Raltegravir: an integrase inhibitor for HIV-1. Expert Opin Investig Drugs. 2008 Mar;17(3):413-22. doi: 10.1517/13543784.17.3.413.
- Sedaghat AR, Dinoso JB, Shen L, Wilke CO, Siliciano RF. Decay dynamics of HIV-1 depend on the inhibited stages of the viral life cycle. Proc Natl Acad Sci U S A. 2008 Mar 25;105(12):4832-7. doi: 10.1073/pnas.0711372105. Epub 2008 Mar 24.
- Funderburg NT, Xu D, Playford MP, Joshi AA, Andrade A, Kuritzkes DR, Lederman MM, Mehta NN. Treatment of HIV infection with a raltegravir-based regimen increases LDL levels, but improves HDL cholesterol efflux capacity. Antivir Ther. 2017;22(1):71-75. doi: 10.3851/IMP3091. Epub 2016 Oct 14.
- Funderburg NT, Andrade A, Chan ES, Rosenkranz SL, Lu D, Clagett B, Pilch-Cooper HA, Rodriguez B, Feinberg J, Daar E, Mellors J, Kuritzkes D, Jacobson JM, Lederman MM. Dynamics of immune reconstitution and activation markers in HIV+ treatment-naive patients treated with raltegravir, tenofovir disoproxil fumarate and emtricitabine. PLoS One. 2013 Dec 18;8(12):e83514. doi: 10.1371/journal.pone.0083514. eCollection 2013.
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
2008年5月1日
初级完成 (实际的)
2009年1月1日
研究完成 (实际的)
2010年4月1日
研究注册日期
首次提交
2008年4月16日
首先提交符合 QC 标准的
2008年4月16日
首次发布 (估计)
2008年4月18日
研究记录更新
最后更新发布 (实际的)
2021年11月1日
上次提交的符合 QC 标准的更新
2021年10月28日
最后验证
2021年10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.