EUCTR2004-002254-59-GB进行中（未招募）1 期
A phase 3, open label, randomised, parallel group study to compare the effect on prevention and resolution of treatment related adverse events of a simplified, once daily regimen of a fixed dose combination tablet of emtricitabine and tenofovir DF versus twice daily co-formulated zidovudine and lamivudine (Combivir®) or zidovudine and lamivudine, in virologically suppressed, HIV infected patients taking efavirenz. - SWEET Study
Gilead Sciences Limited0 个研究点目标入组 220 人开始时间: 2005年2月24日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 220
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
- •1) Adult ( > 18 years) male and non-pregnant female HIV-1 infected patients
- •2) Patients maintained on stable antiretroviral therapy consisting of EFV given with Combivir® or AZT+3TC for at least 6 months
- •3) Patients with viral loads < 50 copies/ml on last 2 consecutive tests and < 400 copies/ml for > 3 months
- •4) Patients requiring a lipid lowering agent must be established on a stable dose/frequency for at least 12 weeks prior to Baseline and be expected to continue at a stable dose/frequency for the duration 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
- •1) Patients with known resistance (including primary resistance) to any of the study medications – TDF, FTC, AZT, 3TC, EFV
- •2) Patients co-infected with hepatitis B
- •3) Patients receiving anabolic steroids
- •4) Patients receiving ongoing therapy with nephrotoxic agents
- •5) Patients with history of AZT monotherapy
- •6) Patients with a Creatinine Clearance of <60ml/min
- •7) Patients with a Karnofsky score <50
- •8) Patients with a prior history of significant renal disease
- •9) Patients with a prior history of osteopenia / osteoporosis
- •10) Patients who have had a blood transfusion in last 6 weeks
- •11) Patients with AST / ALT > 5 x ULN
研究者
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