EUCTR2008-002043-16-IT进行中（未招募）不适用
A phase 4, open label, randomised, controlled study to assess the effect on lipid profile of switching a stable HAART regimen of fixed dose Kivexa + Kaletra to Truvada + Kaletra in adult HIV-1 infected subjects with raised cholesterol - Rocket II
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 160
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
- •Documented confirmed total fasted cholesterol > or = 5.2 mmol/L (= or > 200 mg/dL) for last two consecutive testings (at least 4 weeks apart) with last result < or = 4 weeks prior to Screening
- •Plasma HIV 1 RNA < 50 copies/mL at Screening and > or = 12 weeks prior to Screening
- •Stable HAART regimen of ABC/3TC + LPV/r for at least 24 weeks prior to Screening
- •No previous TDF, FTC or Adefovir (ADV) therapy
- •No Hepatitis B infection with viral load > 1000 copies/mL and no Hepatitis C infection requiring therapy
- •No treatment with any interferon or pegylated interferon within 18 months prior to Screening
- •Concomitant lipid regulating therapy is permitted but must be stable for at least 12 weeks prior to Screening and remain stable throughout the treatment phase of the study
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Pregnant or lactating subjects
- •Previous treatment with emtricitabine (FTC), tenofovir DF (TDF) or adefovir dipivoxil (ADV)
- •Known hypersensitivity to emtricitabine (FTC), tenofovir DF (TDF), Truvada or any of the excipients (e.g., lactose monohydrate, see 5.2.1)
- •Documented resistance to any of the study drugs (either genotypic or phenotypic)
- •Severe hepatic impairment
- •Hepatitis B infection with viral load > 1000 copies/mL at Screening or Hepatitis C infection requiring therapy
- •Treatment with any interferon or pegylated interferon within 18 months prior to Screening
- •Hepatic transaminases (aspartate aminotransferase [AST] and alanine aminotransferase [ALT]) = or > 5 upper limit of normal (ULN)
研究者
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