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
- 12
- 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
- •HIV-infected.
- •Screening viral load at least 5000copies/mL.
- •R5/X4-tropic virus at screening.
- •Total prior antiretroviral experience of at least 3 months.
- •Documented resistance to at least one drug in each of the following classes: nucleoside reverse transcriptase inhibitors (NRTI), non-nucleoside reverse transcriptase inhibitors (NNRTI), and protease inhibitors (PI), stable antiretroviral regimen (or no antiretroviral treatment) for at least 4 weeks before screening.
- •Able to receive a ritonavir-boosted protease inhibitor during treatment studies.
- •Women of childbearing potential must use specific forms of contraception.
排除标准
- •Acute laboratory abnormalities.
- •History of pancreatitis or hepatitis, hepatitis B or hepatitis C coinfection, or any chronic liver disease. Screening liver function tests will be used to determine eligibility.
- •R5-tropic only.
- •X4-tropic only.
- •non-phenotypeable virus at screening.
- •Changes to antiretroviral therapy from 4 weeks prior to screening until Day 1 of treatment study.
- •Pregnancy or breastfeeding women.
- •Recent participation in an experimental drug trial.
- •Prior use of a CCR5 or CXCR4 antagonist.
- •Significant ECG abnormalities or significant history of active pancreatitis, hepatitis, opportunistic infections, malabsorption disorders, cancer, or severe illness.
- •Current use of certain medications may exclude participation in this study.
- •Additional qualifying criteria and laboratory test requirements to be assessed by study physician.
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 (12)
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