A Long Term Open-Label Extension Study Of Lersivirine For The Treatment Of HIV-1 Infection
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Number of Participants With Plasma Human Immunodeficiency Virus - 1 (HIV-1) Ribonucleic Acid (RNA) Level <50 Copies/mL at 144 Weeks From Day 1 of the Parent Protocol
研究概览
简要总结
This is a study to assess long-term safety and efficacy of lersivirine in patients who have completed 96 weeks of treatment with lersivirine in studies A5271015 and A5271022.
详细描述
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
- Parallel
- 主要目的
- Treatment
- 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 must complete of 96 weeks of treatment with lersivirine (or comparator where required by local regulation) in one of the parent protocols (A5271015 or A5271022).
- •Patients must have had a viral load less than 50 copies/mL at Week 84 of the parent protocol.
- •For women who can have children, a negative urine pregnancy test at the Day 1 visit.
排除标准
- •Patients with any Grade 4 Division of AIDS toxicity (except for lipids and asymptomatic glucose elevations will not be included in this trial.
- •Patients being treated with another investigational product or in another clinical trial, except the lersivirine parent protocols will not be included in this trial.
研究组 & 干预措施
LRV 500mg
干预措施: lersivirine (Drug)
LRV 750mg +TVD
干预措施: lersivirine (Drug)
EFV
干预措施: efavirenz (Drug)
LRV 750mg+ DRV/r + OBT
干预措施: lersivirine (Drug)
LRV 1000mg +DRV/r + OBT
干预措施: lersivirine (Drug)
ETR
干预措施: etravirine (Drug)
结局指标
主要结局
Number of Participants With Plasma Human Immunodeficiency Virus - 1 (HIV-1) Ribonucleic Acid (RNA) Level <50 Copies/mL at 144 Weeks From Day 1 of the Parent Protocol
时间窗: 144 Weeks from Day 1 of the parent protocol
Number of participants with HIV-1 RNA level \<50 copies/mL plasma was summarized at 48 weeks i.e. 144 weeks from Day 1 of the parent protocol. Roche Amplicor HIV-1 Monitor assay was used to measure the HIV-1 RNA level.
次要结局
- Number of Participants With Plasma HIV-1 RNA Level <50 Copies/mL up to Week 208(Up to Week 208)
- Change From Baseline in CD4+ Lymphocyte Counts (Absolute) at 144 Weeks From Day 1 of the Parent Protocol(144 Weeks from Day 1 of the parent protocol)
- Change From Baseline in CD4+ Lymphocyte Counts (Percentage) at 144 Weeks From Day 1 of the Parent Protocol(144 Weeks from Day 1 of the parent protocol)
- Change From Baseline in CD4+ Lymphocyte Counts (Absolute) at 192 Weeks From Day 1 of the Parent Protocol(192 Weeks from Day 1 of the parent protocol)
- Change From Baseline in CD4+ Lymphocyte Counts (Percentage) at 192 Weeks From Day 1 of the Parent Protocol(192 Weeks from Day 1 of the parent protocol)
- Virology Analysis Participant Accountability From Week 96 Through Study Termination(Week 96 through study termination)