NCT01060618已完成2 期
Estudio Comparativo de Dos métodos Para Predecir el Uso de Co-receptores Por el Virus de la Inmunodeficiencia 1 (HIV-1): el Ensayo fenotípico (Trofile ESTA®) y la Respuesta virológica a Corto Plazo a un Antagonista de CCR5
Asociacion para el Estudio de las Enfermedades Infecciosas8 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2009年5月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 8
- 主要终点
- To determine if there is a correlation between the Trofile ESTA® test for viral tropism and the viral load reduction after a short treatment with maraviroc in naïve patients (patients with no previous HAART)
研究概览
简要总结
The summary of the Study is to compare two methods in order to predict how the 1-HIV will use a co-receptor: the use of an accredited test (TROFILE ESTA®) and the viral response to a CCR5 antagonist in the short term.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients willing to give, sign and date the Informed Consent Form to participate in the Study and to donate their samples for cell and molecular Studies, after receiving the appropriate information about the Study design, the main objective of the Study and the potential risks.
- •Patients aged >
- •Patients with chronic HIV infection
- •Patients with no previous HAART (naïve patients).
- •Patients that do not meet HAART starting criteria.
- •Viral load >1.000 HIV RNA copies/mL
- •Patients able to understand the Study objectives and able to perform frequent visits to the Study Site.
排除标准
- •Prior HAART (regardless of the HAART type).
- •Pregnancy or willingness to get pregnant during the Study.
结局指标
主要结局
To determine if there is a correlation between the Trofile ESTA® test for viral tropism and the viral load reduction after a short treatment with maraviroc in naïve patients (patients with no previous HAART)
时间窗: 10 days of treatment per patient
次要结局
- To establish a viral load reduction cut point, which would differentiate R5-tropic virus from non-R5 tropic virus(X4/dual/mixed).(1 month per patient)
- To assess the viral response to a CCR5 antagonist according to the viral tropism identified in the phenotypic Study.(1 month per patient)
- Safety assessment throughout the Study(12 months)
- Maraviroc effects assessment in the drug-resistance evolution in naïve patients(12 months)
- Tropism changes assessment since the Screening period(1 month per patient)
研究者
研究点 (8)
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