NCT00197197终止3 期
A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study to Compare the Efficacy and Safety of GW873140 400mg BID in Combination With a Ritonavir-containing Optimized Background Therapy (OBT) Regimen Versus Placebo Plus OBT Over 48 Weeks.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 13
- 主要终点
- HIV viral load response at 24 and 48 weeks.
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of the CCR5 antagonist GW873140 or placebo in combination with an optimized background regimen in treatment-experienced HIV-infected subjects with R5/X4-tropic virus
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
HIV viral load response at 24 and 48 weeks.
时间窗: 24 and 48 weeks
次要结局
- Safety and tolerability, change in T-cell count, disease progression, viral resistance,tropism at failure, pharmacokinetics, health outcomes.Liver tests will be done every 2 weeks for 24 weeks.(every 2 weeks for 24 weeks)
研究者
研究点 (13)
Loading locations...
相似试验
终止
3 期
Study Of Chemokine Coreceptor 5 (CCR5) Antagonist GW873140 In R5-Tropic Treatment-Experienced HIV-Infected SubjectsInfection, Human Immunodeficiency Virus INCT00197145ViiV Healthcare24
终止
3 期
Chemokine Coreceptor 5 (CCR5) Antagonist GW873140 In R5-Tropic Treatment-Experienced HIV-Infected SubjectsHIV InfectionNCT00297076GlaxoSmithKline406
已完成
2 期
Safety/Effectiveness of Oral Chemokine Coreceptor 5 (CCR5) Antagonist INCB009471 in R5-tropic HIV Infected PatientsHIV InfectionsNCT00393120Incyte Corporation45
已完成
2 期
Oral GW766944 (Oral CCR3 Antagonist)AsthmaNCT01160224GlaxoSmithKline60
已完成
1 期
A Study to Evaluate RMC-035 in Subjects Undergoing Cardiac SurgeryAcute Kidney Injury (AKI)NCT04829916Guard Therapeutics AB13