EUCTR2006-006174-19-GB进行中（未招募）1 期
A randomised, open label, phase IV comparative study to determine the effects on renal function of continuing treatment with tenofovir versus replacement with abacavir in HIV positive persons - Renal switch study
St Stephens AIDS Trust0 个研究点目标入组 30 人开始时间: 2006年11月22日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
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
- •1. The ability to understand and sign a written informed consent form, prior to participation in any screening procedures and must be willing to comply with all study requirements
- •2. Participated in screening protocol SSAT 017 (within the last 6 months)
- •3. Stable on tenofovir [tenofovir 300mg (Viread®) or Tenofovir/lamivudine 300/200mg Truvada®)] for at least 6 months
- •4. Documented HIV-1 RNA of less that 50 copies/ml (within the last 3 months)
- •5. At least 18 years of age
- •6. Abnormal renal function (MDR GFR 50-90ml/min/1.73m², serum cystatin C> 1.5 X upper limit of normal range)
- •7. Negative HLA B5701 test at least two weeks prior to the baseline visit
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patients currently taking or who have taken any nephrotoxic drugs within th elast 3 months: e.g. Adefovir, cidofovir, aminoglycosides, metronidazole, amphoteracin, foscarnet, IV pentamadine
- •2. Requirement to commence any new renal toxic drugs
- •3. Pregnant or lactating women
研究者
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