COVER - Continuing Observation After Vicriviroc (VCV) Exposure Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 主要终点
- Incidence of malignancies, AIDS-defining events, other clinical events of importance, and death.
研究概览
简要总结
Nonrandomized, prospective, observational, multi-site registry to assess long-term safety, clinical outcome, deaths, and evolution of viral tropism in HIV subjects who completed or discontinued participation in Phase 2 or 3 clinical trials involving vicriviroc. Subjects will be followed for up to 5 years.
详细描述
A non-probability sampling method will be used. Subjects will be requested to enroll in the registry after having completed or discontinued participation in a Phase 2 or 3 study involving vicriviroc.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Subjects must have participated in a Phase 2 or 3 study involving vicriviroc, and must have received, but are no longer receiving study medication.
排除标准
- •Unwillingness to participate in the registry or give informed consent.
研究组 & 干预措施
Previous vicriviroc 30 mg QD
Subjects who previously received vicriviroc 30 mg daily in a Phase 2 or 3 clinical trial.
干预措施: Vicriviroc maleate (Drug)
Previous vicriviroc 20 mg QD
Subjects who previously received vicriviroc 20 mg daily in a Phase 2 or 3 clinical trial.
干预措施: Vicriviroc maleate (Drug)
Control Group
Subjects who previously received active control or placebo in a Phase 2 or 3 clinical trial involving vicriviroc.
干预措施: Placebo (Drug)
Control Group
Subjects who previously received active control or placebo in a Phase 2 or 3 clinical trial involving vicriviroc.
干预措施: Emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg (Drug)
结局指标
主要结局
Incidence of malignancies, AIDS-defining events, other clinical events of importance, and death.
时间窗: Information regarding clinical outcome will be collected every 6 months. Deaths will be collected on an ongoing basis.
次要结局
- Incidence of change in plasma viral tropism, time to change in plasma viral tropism, and change in HIV RNA and CD4+ counts, if available.(Every 6 months.)