EUCTR2004-001779-20-GB进行中（未招募）1 期
A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF A NOVEL CCR5 ANTAGONIST, UK-427,857, IN COMBINATION WITH OPTIMIZED BACKGROUND THERAPY VERSUS OPTIMIZED BACKGROUND THERAPY ALONE FOR THE TREATMENT OF ANTIRETROVIRAL EXPERIENCED, NON CCR5-TROPIC HIV-1 INFECTED SUBJECTS
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 186
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •HIV-1 RNA superior to or equal to 5000 copies/mL measured by Roche Amplicor HIV-1 monitor at screening visit.
- •Stable pre-study antiretroviral regimen, or on no antiretroviral agents, for at least 4 weeks.
- •Treatment experience criteria as defined in the protocol.
- •A negative urine pregnancy test at the baseline visit prior to receiving the first dose of study medication for women child bearing protential.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patient requiring treatment with more than 6 antiretroviral agents (excluded low dose ritonavir).
- •Prior treatment with UK-427,857 or another experimental HIV entry inhibitor for more than 14 days.
- •Suspected or documented active, untreated HIV-1related opportunistic infection (OI) or other conditions requiring acute therapy (eg Hepatitis C virus infection) at the time of randomisation.
- •R5 virus phenotype only, as determined by PhenoSense viral entry assay.
- •Renal insufficiency, increased bilirubin/AST/ALT.
研究者
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