EUCTR2005-001057-21-PT进行中(未招募)1 期
Vicriviroc (SCH 417690) in Combination Treatment with Optimized ART Regimen in Experienced Subjects (VICTOR-E1) - VICTOR-E1
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
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
- 性别
- All
入选标准
- •Adult subjects with documented HIV infection with R5-only tropism
- •Prior therapy for greater than or equal to 3 months with greater than or equal to 3 classes of currently marketed antiretroviral agents (NRTIs,
- •NNRTIs, PIs, or fusion inhibitors) at any time prior to screening
- •HIV RNA greater than or equal to 5000 copies/mL on a stable ART regimen
- •Greater than or equal to 1 genotypically documented resistance mutation to a reverse transcriptase (RT) inhibitor and greater than or equal to 1 primary resistance mutation to a PI
- •Acceptable hematologic, renal and hepatic laboratory parameters
- •Are the trial subjects under 18? no
- •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
- •No history of recurrent seizure or CNS condition predisposing to seizure
- •No active AIDS-defining opportunistic infection
- •Subjects who have previously used a CCR5 inhibitor for greater than 4 weeks and/or within 30 days of the screening visit.
研究者
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