ChiCTR-IOR-15007465进行中（未招募）4 期
以基因亞型指導低劑量依法韋侖在華裔愛滋病病毒感染者的臨床應用
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Proportion of subject having sufficient viral suppression, viral load < 75 copies per mL, 4 months
研究概览
简要总结
以基因亞型指導低劑量依法韋侖在華裔愛滋病病毒感染者的臨床應用
研究设计
- 研究类型
- 干预性研究
- 主要目的
- 随机交叉对照
入排标准
- 年龄范围
- 18 至 —（—）
- 性别
- All
入选标准
- •HIV-infected adults older than 18 years old;
- •Stable CD4 T-cell counts (over 200 cells per uL) and undetectable viral load (plasma HIV-1 RNA < 75 copies per mL);
- •on HAART containing standard dose EFV and 2 nucleoside/nucleotide reverse transcriptase inhibitors (e.g. tenofovir and emtricitabine).
排除标准
- •pregnant or nursing mothers;
- •have concurrent opportunistic infection or malignant disease, or any AIDS-defining illness;
- •on treatment or prophylaxis for an opportunistic infection;
- •have inadequate renal function (estimated creatinine clearance of <50 mL/min) or significantly deranged laboratory tests (e.g. ALT 1.5*upper limit of normal);
- •have documented non-adherence to study medications or HAART or documented history of illicit substance abuse;
- •illiterate or unable to communicate with study team; or
- •unable or refuse to participate or give consent.
研究组 & 干预措施
Two groups
Efavirenz 400mg orally daily versus 600mg orally daily, in combination with other anti-retrovirals, 4 months
结局指标
主要结局
Proportion of subject having sufficient viral suppression, viral load < 75 copies per mL, 4 months
时间窗: 4 months
次要结局
- Plasma concentration of efavirenz, 4 months(4 months)
- sleep scale
- occurrence of adverse effects or discontinuation
研究者
研究点 (1)
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