EUCTR2005-000793-45-DE进行中（未招募）不适用
Open-label safety study of TMC114 in combination with low dose RTV and other ARVs in highly experienced HIV-1 infected patients with limited or no treatment options.
Tibotec Pharmaceuticals Ltd.0 个研究点目标入组 600 人开始时间: 2006年5月17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
- 600
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. Patient has voluntarily signed the informed consent before initiation of study procedures.
- •2. Patient with documented HIV-1 infection.
- •3. Male or female patient over 18 years of age.
- •4. Patient has limited or no treatment options because of multiple treatment failures.
- •5. Negative pregnancy test for females of childbearing potential.
- •6. CD4 cell count = 100 cells/mm3.
- •7. Viral load = 10000 copies/mL.
- •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. Primary HIV-infection.
- •2. Patient is eligible for other Tibotec-sponsored trials.
- •3. Prior or current participation to a trial with TMC114 (except for Phase I studies conducted in HIV-infected patients).
- •4. Use of disallowed concomitant therapy.
- •5. Use of investigational medication within the last 90 days. The following exceptions apply:
- •- abacavir/lamivudine and tenofovir/emtricitabine fixed dose combinations;
- •- tipranavir; TMC114 should not be used within 14 days following the use of tipranavir. A minimal 14-day washout period is required in which tipranavir must be either interrupted or substituted to an alternative investigator selected PI regimen until baseline visit (Day 1).
- •6. Pregnant or breast-feeding female.
- •7. Female patient of child bearing potential without the use of effective non-hormonal birth control methods or not willing to continue practicing these birth control methods from screening until the last trial related activity.
- •8. Previously demonstrated clinically significant allergy or hypersensitivity to any of the excipients of the investigational medication (TMC114) or RTV.
- •9. Patients with the following laboratory abnormalities as defined by a standardized grading scheme based on the DAIDS table (updated version form December 2004):
- •- Any grade 3 or 4 toxicity with the following exceptions:
- •- Patients with pre-existing diabetes or asymptomatic glucose elevations of grade 3 or 4.
- •- Patients with asymptomatic triglyceride elevations of grade 3 or 4 or cholesterol elevations = grade 3.
- •10. Patient with clinical or laboratory evidence of active liver disease, liver impairment/dysfunction or cirrhosis irrespective of liver enzyme levels.
研究者
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