EUCTR2013-002830-19-GB进行中（未招募）1 期
A Phase 3, Two-Part Study to Evaluate the Efficacy of Tenofovir Alafenamide versus Placebo Added to a Failing Regimen Followed by Treatment with Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide plus Atazanavir in HIV-1 Positive, Antiretroviral Treatment-Experienced Adults
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 55
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
- •-Age = 18 years of age at Screening
- •-Estimated glomerular filtration rate (Cockcroft Gault equation) = 50 mL/min
- •-HIV-1 RNA = 500 copies/mL but =100,000 copies/mL at screening (Roche COBAS TaqMan v2.0)
- •-Currently taking a failing ARV regimen
- •-Screening and historical genotype report (if available) showing either 1 to 3 thymidine-analogue mutations (TAMs) or K65R as well as M184V, and at least one primary NNRTI and/or one primary PI mutation.
- •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 100
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Screening and historical genotype reports (if available) shows Q151M, T69ins, or more than 3 thymidine-analogue mutations (TAMs) in RT, or I50L, I84V, N88S in PR.
- •-Patients with Q151M or T69ins present on screening or historical genotype
- •-History of integrase strand transfer inhibitor (INSTI) use
- •-Evidence of chronic viral Hepatitis B or C infection
研究者
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