Etravirine Plus 2 Analogs in HIV-infected Patients
Virological Efficacy and Safety of Etravirine Plus 2 Active Nucleos(t)Ide Reverse-transcriptase Inhibitors (NRTIs) in HIV-1-infected Patients
研究概览
地位
条件
详细说明
Methods: prospective, single arm multicenter clinical trial without entry restrictions on plasma HIV-RNA (VL) or CD4 with a planned duration of 52 weeks.
The primary clinical endpoint is the percentage of subjects with therapeutic success on etravirine 400 mg/day (200 mg bid or 400 mg qd) plus 2 active NRTIs after 12 months. Efficacy data will be analyzed by on-treatment and by intention-to-treat analyses (noncomplete/missing equals failure), considering treatment failure as either treatment interruption whatever the reason (adverse events, death, or loss to follow-up) or virological failure, defined as inability to suppress the VL to less than 50 copies/ml after 24 weeks on treatment or a confirmed VL of more than 200 copies/ml in patients who had previously achieved a viral suppression or had an undetectable viral load at inclusion.
Patients missing two consecutive scheduled visits were considered lost to follow-up. The safety and tolerability of the studied medications will be evaluated by means of clinical adverse events, physical examination and laboratory results.
NRTIs prescribed as part of HAART were selected by the responsible physicians on the basis of previous antiretroviral treatments and/or genotypic resistance testing.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Cordoba、西班牙、14004
- Hospital Universitario Reina Sofía
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Granada、西班牙、18014
- Hospital Universitario Virgen de las Nieves
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Granada、西班牙、04009
- Hospital Universitario San Cecilio
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Jaen、西班牙、23001
- Hospital Ciudad de Jaén
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Malaga、西班牙、29010
- Hospital Universitario Virgen de la Victoria
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Malaga、西班牙、29010
- Hospital Universitario Carlos Haya
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Sevilla、西班牙、41013
- Hospital Universitario Virgen del Rocio
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Sevilla、西班牙、41014
- Hospital Universitario Virgen de Valme
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Cadiz
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La Linea de la Concepción、Cadiz、西班牙、11300
- Hospital La Linea de la Concepción
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Puerto Real、Cadiz、西班牙、11510
- Hospital Universitario Puerto Real
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Malaga
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Marbella、Malaga、西班牙、29600
- Hospital Costa del Sol
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Older than 18 years, starting an antiretroviral regimen based on etravirine plus 2 NRTIs between January 2009 and June 2010, evidence of activity of all drugs on the basis of treatment history and genotypic resistance testing, informed consent, and at least one follow-up visit.
Exclusion Criteria:
- Genotypic resistance tests with evidence of resistance to any drug used, and concomitant use of drugs with potentially adverse interactions with etravirine pharmacokinetics, such as rifampin.
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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etravirine
Antiretroviral regimens based on etravirine plus 2 active nucleos(t)ide reverse-transcriptase inhibitors (NRTIs)
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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 |
---|---|---|
Virological efficacy
大体时间:52 weeks
|
Percentage of subjects with therapeutic success at month 12. Efficacy data will be analyzed by on-treatment and by intention-to-treat considering treatment failure as either treatment interruption whatever the reason (adverse events, death, or loss to follow-up) or virological failure, defined as inability to suppress the VL to <50 copies/ml after 24 weeks or a confirmed VL of >200 copies/ml in patients who had previously achieved a viral suppression or had an undetectable viral load at inclusion.
Patients missing two consecutive scheduled visits were considered lost to follow-up.
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52 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Safety
大体时间:52 weeks
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The safety and tolerability of the studied medications will be evaluated by means of clinical adverse events, physical examination and laboratory results.
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52 weeks
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合作者和调查者
调查人员
- 首席研究员:Luis F Lopez-Cortes, MD, PhD.、Hospitales Universitarios Virgen del Rocío
- 首席研究员:Francisco Tellez-Perez, MD、Hospital de la Linea de la Concepcion
- 首席研究员:Antonio Vergara-Campos, MD, PhD.、Hospital Universitario de Puerto Real
- 首席研究员:Milagros Garcia-Lazaro, MD、Hospital Universitario Reina Sofia de Cordoba
- 首席研究员:Jose Hernandez-Quero, MD, PhD.、Hospital Universitario San Cecilio
- 首席研究员:Juan Pascuau-Liaño, MD, PhD.、University Hospital Virgen de las Nieves
- 首席研究员:Miguel A Lopez-Ruz, MD, PhD、University Hospital Virgen de las Nieves
- 首席研究员:Mohamed O Mohamed-Balghata, MD、Hospital Universitario Ciudad de Jaen
- 首席研究员:Dr.Javier de la Torre-Lima, MD, PhD、Hospital Costa del Sol
- 首席研究员:Manuel Marquez Solero, MD、Hospital Universitario Virgen de la Victoria
- 首席研究员:Marcial delgado, MD、Hospital Universitario Carlos Haya
- 首席研究员:Fernando Lozano-León, MD, PhD.、Hospital Universitario de Valme
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
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
- LFL-ETR-2010-01
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