EUCTR2005-005264-86-IT进行中（未招募）不适用
Safety, efficacy and Pharmacokinetics of tipRanavir boosted with low-dose ritonavir TPV/r 500 mg/200 mg BID IN a racially and Gender diverse HIV-positive treatment experienced population with a pilot evaluation of therapeutic drug monitoring TDM . The SPRING study is an open-label, multicenter, multinational trial with randomisation to standard of care SOC or TDM TPV/r therapy - SPRING
BOEHRINGER ING.0 个研究点目标入组 800 人开始时间: 2007年3月7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
- 800
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
- •-HIV-1 infected males or females 18 years of age. -Three-class NRTI, NNRTI, and PI treatment-experienced a minimum of 3-months duration for each class with resistance to more than one PI on the screening resistance testing . -CD4 T lymphocyte count 50 cells/mm 3. -Patients must have at least one of the following permutations of ARV medications available and must be willing to use them in the OBR for trial inclusion 1 Two genotypically active reverse transcriptase inhibitors RTIs as defined as two drugs that are reported as sensitive in the genotype report. 2 One genotypically active RTI reported as sensitive in the genotype report and enfuvirtide if not used previously. For patients who had previously taken 3TC lamivudine or FTC emtricitabine , these drugs are not considered as sensitive regardless of the genotype report. -The four AIDS defining events listed below are acceptable as long as the event has been cured for at least 2 weeks before screening Visit 1 . Patients with a history of other AIDS defining events are not allowed into the trial. The acceptable prior AIDS defining events include Candidiasis bronchi, trachea, lungs, esophageal Herpes simplex chronic ulcer s 1 month s duration , bronchitis, pneumonitis, or esophagitis Mycobacterium tuberculosis pulmonary or extrapulmonary Pneumonia including Pneumocystis jiroveci formerly carinii pneumonia.
- •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
- •-Known hypersensitivity to any of the ingredients in the tipranavir and ritonavir formulations. -ARV medication na ve. -Genotypic resistance to tipranavir defined as a TPV mutation score 7 . -Patients on recent drug holiday, defined as off ARV medications for at least 7 consecutive days within the month prior to screening. -Female patients of childbearing potential who have a positive serum pregnancy test at screening or entry are breast feeding are planning to become pregnant are not willing to use barrier method contraception are only willing to use an estrogen-containing medication, e.g., ethinyl estradiol, as a method of contraception -Prior tipranavir use. -Inability to adhere to the requirements of the protocol, including active substance abuse as assessed by the investigator.
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