A Phase 2b Open-Label Rollover Study For Subjects Discontinuing From UK-453,061 Studies For The Treatment Of HIV-1 Infected Subjects
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment-emergent Adverse Events, Serious Adverse Events and Participants Who Discontinued Due to Adverse Events
研究概览
简要总结
The purpose of the protocol is to assess long-term safety and tolerability of subjects who discontinue for any reason from UK-453,061 qualifying studies.
详细描述
To assess long term safety and tolerability of subjects who discontinue for any reason from UK-453,061 studies. The study will also assess efficacy of the subsequent regimens in these patients. The trial was terminated prematurely on January 29, 2013, due to the decision of the sponsor to discontinue development of lersivirine. The decision to terminate the trial was not based on any safety or efficacy concerns.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Previous participation in a qualifying study.
- •Male or female at least 18 years of age available for a follow-up period of at least 96 weeks.
排除标准
- •Concurrent treatment in another clinical trial.
- •Unwilling or unable to be followed for 12 months
研究组 & 干预措施
Anti-retroviral therapy
Anti-retroviral therapy
干预措施: No drug will be administered (Drug)
结局指标
主要结局
Number of Participants With Treatment-emergent Adverse Events, Serious Adverse Events and Participants Who Discontinued Due to Adverse Events
时间窗: End of Study visit or the Early Termination visit
The numbers of participants with treatment emergent adverse events, serious adverse events or discontinuation due to adverse events was reported.
次要结局
- Number of Participants With Human Immunodeficiency Virus - 1 (HIV 1) Ribonucleic Acid (RNA) Level <50 Copies/mL at Baseline, Month 6, Month 12 and Last Visit(Baseline, Month 6, Month 12 and Last visit)
- Number of Participants With HIV 1 RNA Level <50 Copies/mL or Below the Lower Limit of Quantification (LLOQ) of the Assay at Baseline, Month 6, Month 12 and Last Visit(Baseline, Month 6, Month 12 and Last visit)
- Absolute Cluster of Differentiation 4+ (CD4+) Cell Count (Cells/uL) at Baseline, Month 6 and Month 12(Baseline, Month 6 and Month 12)
- CD4+ Cell Count (Percentage) at Baseline, Month 6 and Month 12(Baseline, Month 6 and Month 12)