EUCTR2014-003710-84-GB进行中（未招募）1 期
The Central Nervous System Effects of Two Different HIV-Integrase Inhibitor Containing Antiretroviral Regimens. - The CNS Integrase Inhibitor Study
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
- 22
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 infected subjects
- •Signed informed consent
- •No contraindication to lumbar puncture examination on screening MRI of brain.
- •Plasma HIV RNA < 200 copies/mL at screening and on at least one other occasion over the last 3 months
- •Acceptable medical history and laboratory parameters (haematology and chemistry) in the opinion of the investigator
- •On a stable antiretroviral regimen for >4 months comprising of:
- •raltegravir 400mg twice daily
- •tenofovir 245 mg daily
- •emtricitabine 200 mg daily
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •Existing neurological disease
- •Current history of major depression or psychosis
- •Recent head injury (past three months)
- •Current alcohol abuse or drug dependence
- •Active opportunistic infection or significant co-morbidities
研究者
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