ACTRN12610001097033进行中（未招募）3 期
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 Human Immunodeficiency virus (HIV)-infected individuals over 96 weeks.
ational Centre for HIV Epidemiology and Clinical Research0 个研究点目标入组 630 人开始时间: 2010年12月15日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 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
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 16 Years 至 o limit（—）
- 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 <350 cells/microlitres or previous aquired immune deficiency syndrome-defining illness
- •*HIV RNA greater than or equal to 1000 copies/mL
- •*no prior exposure to antiretrovirals (including short course antiretrovirals for preventing mother to child transmission)
- •*calculated creatinine clearance (CLCr) must be greater than or equal to 50 mL/min (Cockcroft-Gault formula)
- •*provision of written informed consent.
排除标准
- •*the following laboratory values:
- •*absolute neutrophil count (ANC) <500 cells/microlitre
- •*hemoglobin <7.0 g/dL
- •*platelet count <50,000 cells/microlitre
- •*alanine aminotransferase and/or aspartate aminotransferase >5 x upper limit of normal
- •*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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