EUCTR2005-002437-13-LT进行中（未招募）不适用
Early access of TMC114 in combination with low-dose ritonavir (RTV) and other antiretrovirals (ARVs) in highly treatment experienced HIV-1 infected subjects with limited to no treatment options.
Tibotec Pharmaceuticals Ltd.0 个研究点目标入组 5,000 人开始时间: 2005年12月13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
- 5,000
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. Subject has voluntarily signed the informed consent before initiation of study procedures.
- •2. Subject with documented HIV-1 infection.
- •3. Male or female subject 18 years of age or older.
- •4. Subject has limited or no treatment options due to virological failure or intolerance to multiple ARV regimens.
- •5. Subject is at least 3 class experienced and has previously received 2 different PI based regimens.
- •6. Subject is not achieving adequate virologic suppression on his/her current regimen and at risk of clinical or immunologic progression*. (* May not be applicable if the subject is a roll over subject from TMC114-C202, TMC114-C209, TMC114-C213, TMC114-C215 or any other sponsor selected TMC114 trial without treatment interruption.)
- •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-1 infection.
- •2. Subject is eligible for other Tibotec sponsored HIV-1 trials.
- •3. Prior or current participation in a trial with TMC114 (This criterion does not apply to the following trials:
- •- TMC114-C209
- •- TMC114-C202, TMC114-C213 and TMC114-C215 either if the subject has completed the 144 weeks treatment period or experiences a virologic failure as defined in the originating protocol and requires treatment with TMC114 in combination with an ARV that is not allowed per the originating protocol.
- •- Other trials with TMC114 after prior discussion with and approval from the sponsor.)
- •4. Any condition (including but not limited to alcohol and drug use), which, in the opinion of the investigator, could compromise the subject’s safety or adherence to the study protocol.
- •5. Use of disallowed concomitant therapy (see Section 5.3.8).
- •6. Use of investigational medication within the last 30 days or during the trial.
- •Exceptions:
- •- use of investigational fixed dose combinations abacavir/lamuvidine and tenofovir/emtricitabine (if applicable, based on the status of local approval);
- •- use of tipranavir (if applicable, based on the status of local approval). Tipranavir is allowed until the day before TMC114 intake (wash out period of 30 days is not applicable for tipranavir);
- •- investigational ARVs for which favorable pharmacokinetic interaction and safety data support co-administration with TMC114 and low-dose RTV. Investigational drugs that fulfill this criterion will only be allowed after the sponsor has informed the investigators, applicable Ethics Committees and Health Authorities.
- •7. Any active clinically significant disease (e.g., cardiac dysfunction, pancreatitis, acute viral infection) or findings during screening of medical history or physical examination that is not either resolved or stabilized for at least 30 days before the screening phase of the trial.
- •8. Pregnant or breast-feeding female.
- •9. Female subject of childbearing potential not using effective non-hormonal birth control methods or not willing to continue practicing these birth control methods from screening until the last trial related activity.
- •10. Subjects with the following laboratory abnormalities as defined by a standardized grading scheme based on the DAIDS table (updated version from December 2004, see Section 7.2).
- •Any grade 3 or 4 toxicity of the selected laboratory parameters as described in the section Subjects and Disease Characteristics (see Section 5.4.3).
- •11. Subject with clinical or laboratory evidence of active liver disease, liver impairment / dysfunction or cirrhosis irrespective of liver enzyme levels.
- •12. Previously demonstrated clinically significant allergy or hypersensitivity to any of the excipients of the investigational medication (TMC114) or RTV.
研究者
相似试验
进行中（未招募）
不适用
Early access of TMC114 in combination with low-dose ritonavir RTV and other antiretrovirals ARVs in highly treatment experienced HIV-1 infected subjects with limited to no treatment options. - TMC114-C226EUCTR2005-002437-13-ITTIBOTEC PHARMACEUTICALS LTD.15,000
已完成
4 期
Early Access to Low-dose Ritonavir (TMC114/r) and Other Antiretrovirals (ARVs) for Treatment-naive or Early Treatment Experienced in HIV-1 PatientsHIV-1NCT01702090Janssen-Cilag Ltd.10
Approved For Marketing
不适用
TMC114-C226: An Early Access Program to Evaluate the Long-term Safety and Tolerability of TMC114 Combined With a Low Dose of Ritonavir (TMC114/r) With Other Antiretrovirals, for HIV-1 Infected Patients Who Have Failed Multiple Antiretroviral Regimens.HIV InfectionsNCT00245739Tibotec Pharmaceuticals, Ireland
进行中（未招募）
不适用
未命名试验EUCTR2006-002499-16-DEJanssen R&D Ireland
已完成
不适用
Early Access of TMC125 in combination with other antiretrovirals in treatment-experienced HIV-1 infected subjects with limited treatment options.HIV-110047438NL-OMON30522Janssen-Cilag120