EUCTR2008-004970-41-FR进行中（未招募）不适用
Phase II open-label randomized multicenter trial to compare the efficacy and safety of two different doses of raltegravir and efavirenz, all in combination with tenofovir and lamivudine, in naive HIV-1-infected patients receiving rifampin for active tuberculosis. - REFLATE TB
Agence nationale de recherches sur le sida et les hépatites virales. ANRS.0 个研究点目标入组 150 人开始时间: 2008年11月14日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
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
- •Signed informed consent form, adult patients (at least 18 years old), plasma HIV RNA > 1000 copies/ml, HIV-1infection, ART naïve patients or ART for less than 3 months and more than 6 months ago, HIV resistance genotype at baseline showing no mutation to NNRTI and TDF or 3TC, for women of childbearing age negative urinary test for pregnancy and to accept contraceptive methods, confirmed or probable TB, TB treatment including rifampin started since 2 to 4 weeks before screening, to be affiliated to the National Health Care System.
- •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
- •HIV-2 infection, Woman who is pregnant or likely to become so, is breastfeeding or refuses to use contraception, ALT>2,5N, Hb <7g/dl, neutrophils < 750/mm3, platelet<50 000/mm3, bilirubin >5N, lipase >3N, Creatinine clearance <60ml/min as assessed by the Cockcroft method, concomitant treatments including phenytoin or phenobarbital, prior TB with a Mycobacterium tuberculosis strain resistant to rifampin, TB treatment started for more than 4 weeks before screening.
研究者
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