EUCTR2009-013795-44-DE进行中（未招募）不适用
A randomised, double-blind, placebo-controlled, clinical trial to compare the safety and efficacy of reduced dose efavirenz (EFV) with standard dose EFV plus two nucleotide reverse transcriptase inhibitors (N(t)RTI) in antiretroviral-naïve HIV-infected individuals over 96 weeks - Encore1
The Kirby Institute (formerly National Centre in HIV Epidemiology and Clinical Research (NCHECR)), University of New Sou0 个研究点目标入组 630 人开始时间: 2010年4月8日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 630
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
- •HIV-1 positive by licensed diagnostic test
- •aged >16 years of age (or minimum age as determined by local regulations or as legal requirements dictate)
- •50 < CD4 <500 cells/µL
- •No prior AIDS-defining illness, using the CDC 1993 case definition (except pulmonary tuberculosis)
- •HIV RNA =1000 copies/mL
- •no prior exposure to ART (including short course ARVs for preventing MTCT)
- •calculated creatinine clearance (CLCr) = 50 mL/min (Cockcroft-Gault formula)
- •provision of written informed consent.
- •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 630
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 630
排除标准
- •the following laboratory values:
- •- absolute neutrophil count (ANC) <500 cells/µL
- •- hemoglobin <7.0 g/dL
- •- platelet count <50,000 cells/µL
- •- AST and/or ALT >5 x ULN
- •pregnant women or nursing mothers
- •active opportunistic or malignant disease not under adequate control
- •use of immunomodulators within 30 days prior to screening
- •use of any prohibited medications
- •current alcohol or illicit substance use that might adversely affect study participation.
研究者
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