Generic Fixed Dose Combination (FDC) of Tenofovir(TDF) /Lamivudine(3TC)/Efavirenz (EFV) Tablets 300/300/600 mg
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- mid levels of TDF, 3TC, and EFV between brand and generic
研究概览
简要总结
The purpose of this study is to determine the mid levels of the tenofovir, lamivudine, and efavirenz, and 144 weeks safety and efficacy of the generic fixed dose combination of tenofovir /lamivudine/efavirenz tablets 300/300/600 mg in Thai HIV-infected patients.
详细描述
The trial drug FDC of TDF/3TC/EFV is a new formulation combining fixed doses of the nucleoside reverse transcriptase inhibitors lamivudine 300 mg and tenofovir disoproxil fumarate 300 mg with the non nucleoside reverse transcriptase inhibitor efavirenz 600 mg for once daily and one-tablet HAART. Co-formulated TDF/3TC/EFV demonstrated bioequivalent to original individual EFV 3TC and TDF in Indian healthy volunteers (unpublished data). It has not been evaluated in clinical trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Evidence of HIV infection
- •Age> 18 years
- •On a TDF/3TC/EFV (separated pills) containing HAART regimen with a VL < 50 copies within 24 weeks or ARV naïve
- •eGFR >70 cc/min
- •Currently having no AIDS defining illness
- •No history of NRTI/NNRTI/PI failure
- •Willing to adhere to the protocol requirements
排除标准
- •Any history of taking CYP450 inhibitors or inducers drugs within 14 days of enrollment in the study
- •Current pregnancy or lactating or plan to be pregnant
- •Active opportunistic infection
- •ALT more than 2 x upper limit
- •Creatinine more than 1.5 time the upper limit
- •Active drug abuse
研究组 & 干预措施
1
Patients can be either treatment-naïve or treatment-experienced when entering this clinical trial. After meeting the inclusion and exclusion criteria, patients will start with generic FDC of TDF/3TC/EFV 1 pill a day at night time. Only patient who are on individual TDF 3TC and EFV will undergo TDM sampling ( 11-13 hours after dosing) at baseline.
干预措施: generic FDC of TDF/3TC/EFV (Drug)
结局指标
主要结局
mid levels of TDF, 3TC, and EFV between brand and generic
时间窗: 144 weeks
mid levels of TDF, 3TC, and EFV between brand and generic
次要结局
- kidney, liver, CD4 and viral load overtime(144 weeks)