EUCTR2006-001287-23-IT进行中（未招募）不适用
An open-label trial with TMC125 as part of an ART including TMC114/rtv and an investigator selected OBR in HIV-1 infected subjects who participated in a DUET trial TMC125-C206 or TMC125-C216 - ND
TIBOTEC PHARMACEUTICALS LTD.0 个研究点目标入组 300 人开始时间: 2006年8月30日最近更新:
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
- 300
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
- •Subjects who meet all of the following criteria are eligible for this trial 1. Subject was previously randomized in a DUET trial and completed at least 24 weeks of treatment. 2. The subject was virologically failing in a DUET trial. Failure is defined as - not achieving a 1 log10 decrease from baseline in plasma viral load at Week 24, - viral rebound with 2 consecutive measurements at least 0.5 log10 above nadir at Week 24 or later. 3. Subject has voluntarily signed the informed consent form. 4. Subject can comply with the protocol requirements. 5. Subject s general medical condition, in the investigator s opinion, does not interfere with the assessments of the trial.
- •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
- •Subjects meeting one or more of the following criteria cannot be selected 1. Use of disallowed concomitant therapy see Section 5.3.12 . 2. Any treatment-emergent condition or exacerbation of underlying condition during the DUET trial, which in the investigator s opinion would likely compromise the subject s safety or compliance with trial procedures. 3. Female of childbearing potential not using effective birth control methods or not willing to continue practicing these birth control methods during the trial and for at least 30 days after the end of the trial or after the last intake of investigational ARVs, see Section 5.2.4 . 4. Heterosexually active male subject not using effective birth control methods during the trial and until 30 days after the end of the trial or after last intake of investigational ARVs . 5. A grade 3 elevation of amylase and/or lipase except for isolated grade 3 increases of amylase with lipase in normal range and no history of pancreatitis. 6. Any grade 4 toxicity according to the Division of AIDS DAIDS grading table, with the exception of grade 4 elevations of triglycerides or glucose asymptomatic or under non-fasting conditions, and grade 4 elevation of glucose in subjects with pre-existing diabetes. 7. Subjects with clinical or laboratory evidence of significantly decreased hepatic function or decompensation, irrespective of liver enzyme levels INR 1.5 or albumin 30 g/L or bilirubin 2.5 x ULN . 8. Subjects who had to be withdrawn from the DUET trials because of any of the mandatory withdrawal criteria of that trial
研究者
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