EUCTR2005-005023-33-IT进行中（未招募）不适用
Safety and efficacy study of TPV boosted with low dose ritonavir TPV/r 500 mg/200 mg BID in antiretroviral treatment experienced HIV positive patients with HCV or HBV co-infection, with a pilot evaluation of therapeutic drug monitoring TDM . An open-label, multicenter, multinational trial with randomisation to standard of care SOC or TDM TPV/r therapy - ND
BOEHRINGER ING.0 个研究点目标入组 300 人开始时间: 2007年4月3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
- 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
- •-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 . -Chronic hepatitis C Virus infection demonstrated by HCV-RNA positivity or, Chronic hepatitis B infection demonstrated by anti-HBc-IgG Antibody and HB Surface Antigen positivity. -CD4 T lymphocyte count 50 cells/mm 3. -HIV-1 VL 1000 copies/mL at screening. -Patients must have at least one of the following permutations of active ARV medications available and must be willing to use them in the OBR for trial inclusion -Two genotypically active RTIs defined as two drugs that are reported as sensitive in the genotype report. -One genotypically active RTI reported as sensitive in the genotype report and Enfuvirtide ENF if not used previously. For patients who had previously taken 3TC Lamivudine or FTC Emtricitabine , these drugs are not considered as sensitive regardless of genotype report. -Only 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 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
- •-ARV medication na ve. -Genotypic resistance to TPV defined as a TPV mutation score 7 . -Decompensated liver disease, including presence or history of ascites, variceal bleeding, or hepatic encephalopathy or having ever been diagnosed as having hepatic insufficiency of Child Pugh class B or C. -Use of immunomodulatory drugs e.g., interferon, cyclosporin, hydroxyurea, interleukin 2 or antineoplastic agents within 30 days before study entry or during the trial. -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 child-bearing potential who a. have a positive serum pregnancy test at screening or during the study, b. are breast feeding, c. are planning to become pregnant, d. are not willing to use a barrier method of contraception, or e. are only willing to use an estrogen-containing medication, e.g., ethinyl estradiol, as a method of contraception. -Prior tipranavir use -Anticipated need for any interferon-based regimen in the 48 weeks following the study entry -Inability to adhere to the requirements of the protocol, including active substance abuse, as defined by the investigator.
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Safety and efficacy study of TPV boosted with low dose ritonavir (TPV/r) 500 mg/200 mg BID in antiretroviral treatment experienced HIV positive patients with HCV or HBV co-infection, with a pilot evaluation of therapeutic drug monitoring (TDM). An open-label, multicenter, multinational trial with randomisation to standard of care (SOC) or TDM TPV/r therapyTreatment with three-class (NRTI, NNRTI, and PI) experienced HIV positive patients with HCV or HBV co-infection, with a minimum of 3-months duration for each class and have documented resistance to more than one PI. They must be TPV naïve, have at least two available active ARV drugs to construct a background regimen.MedDRA version: 8.1Level: LLTClassification code 10020192Term: HIV-1EUCTR2005-005023-33-PTBOEHRINGER-INGELHEIM200
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