EUCTR2004-001658-10-GB进行中（未招募）1 期
An open-label trial of TMC125 in HIV-1 infected subjects who were randomized in any sponsor selected TMC125 trial to an active control arm and either virologically failed or completed the entire treatment period, or to placebo arm and were treated for at least 48 weeks. - N/A
Tibotec Pharmaceuticals Limited0 个研究点目标入组 170 人开始时间: 2005年4月20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
- 170
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
- •Subjects who meet all of the following criteria are eligible for this trial:
- •1. Subject has signed the Informed Consent Form (ICF) voluntarily;
- •2. Male or female subject, aged 18 years and above;
- •3. Subject having previously been randomized to an active control arm of a sponsor-selected TMC125 trial and has completed the entire treatment period or has met the definition of virological failure, as defined in the original protocol, before TMC125-C211 screening or subjects who were randomized in a fully blinded TMC125 trial, being unblinded after treatment for at least 48 weeks and identified as having received placebo;
- •4. Subject agrees to take TMC125 in combination with the investigator-selected combination therapy consisting of at least 2 drugs (NRTIs and/or allowed PI and/or T-20; low-dose ritonavir [= 400 mg daily dose] is not counted as a separate ARV);
- •5. Subject can comply with the protocol requirements;
- •6. Subject’s general medical condition, in the investigator’s opinion, does not interfere with the assessments and the completion of the trial.
- •Are the trial subjects under 18?
- •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;
- •2. History of or currently active alcohol or substance use which would likely compromise the subject’s safety or compliance with the study procedures;
- •3. Any active clinically significant disease or findings during physical examination that would compromise the subject’s safety;
- •4. Pregnant or breastfeeding female;
- •5. Female subject of childbearing potential without the use of effective birth control methods or not willing to continue practicing these birth control methods during the trial and for at least 14 days after the end of the trial (or the last intake of investigational medication):
- •Note: Hormonal based contraception may not be reliable when taking TMC125, therefore to be eligible for this study, women of childbearing potential should either:
- •(1) use a double barrier method to prevent pregnancy, or
- •(2) use hormonal based contraceptives in combination with a barrier contraceptive, or
- •(3) use an intra-uterine device in combination with a barrier contraceptive, or
- •(4) be non-heterosexually active, practice sexual abstinence or have a vasectomized
- •Note: Women who are postmenopausal for at least 2 years, women with total hysterectomy and women who have a tubal ligation are considered of non-childbearing potential;
- •6. Renal impairment as defined by serum creatinine > 2 x upper limit of normal (ULN);
- •7. Any grade 3 or grade 4 toxicity according to the ACTG grading severity list (except for grade 3 glucose and asymptomatic triglyceride/cholesterol grade 3 or 4 elevations; or asymptomatic and isolated grade 3 or 4 elevations in gamma-glutamyl transferase [GGT] with all other liver enzymes and bilirubin within normal ranges, or isolated grade 3 elevation in amylase with no increase in lipase and no history of pancreatitis);
- •8. Subjects with clinical or laboratory evidence of significantly decreased hepatic function or decompensation, irrespective of liver enzyme levels (International Normalized Ratio > 1.3 or albumin < 30 g/l or direct bilirubin > 2.5 x ULN).
研究者
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