EUCTR2004-001246-33-GB进行中（未招募）不适用
An open label trial of TMC114/RTV in HIV-1 infected subjects who were randomized in the trials TMC114-C201, TMC114-C207 or in sponsor selected Phase I trials. - TMC114-C208
Tibotec Pharmaceuticals Limited Ireland0 个研究点目标入组 89 人开始时间: 2005年2月14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
- 89
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
- •ORIGINAL PART OF THE TRIAL
- •1. Subject has signed the informed consent form voluntarily.
- •2. Male or female subjects aged at least 18 years.
- •3. Previous randomization to one of the treatment groups (including control) in the TMC114-C201, TMC114-C207 trial or in sponsor selected Phase I trials.
- •4. Subject agrees to take at least 2 ARVs including approved NRTIs/NtRTIs, NNRTIs, and/or T-20 in combination with the study medication (TMC114/RTV) from baseline onwards.
- •5. Subject can comply with the protocol requirements.
- •6. Subject’s general medical condition is, in the investigator’s opinion, not interfering with the assessments and the conduct of the trial.
- •EXTENSION PART OF THE TRIAL
- •1. Male or female subject, 18 years and above;
- •2. Subject completed 96 weeks of treatment with TMC114 in the original part of the TMC114-C208 trial and TMC114 is not yet commercially available;
- •3. Subject has signed the informed consent form voluntary;
- •4. Subject can comply with the protocol requirements;
- •5. Subject’s general medical condition, in the investigator’s opinion, does not interfere with the assessments and the conduct of the trial.
- •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
- •ORIGINAL PART OF THE TRIAL
- •1. Use of disallowed concomitant therapy.
- •2. Use of other investigational drugs within 30 days prior to the investigational medication administration
- •3. Current or past history of active alcohol and/or drug use which in the investigator’s opinion would compromise the subject’s safety or compliance to the trial protocol procedures.
- •4. Pregnant or breast-feeding females.
- •5. Female subjects of childbearing potential without the use of effective birth control methods or not willing to continue practicing these birth control methods from screening until at least 30 days after the end of the treatment period.
- •6. Any active or unstable medical condition (e.g., tuberculosis; cardiac dysfunction; pancreatitis; acute viral infections) or findings during physical examination that, in the investigator’s opinion, would compromise the subject’s safety.
- •7. Subject with the certain laboratory abnormalities at screening
- •8. Subject with clinical or laboratory evidence of active liver disease, liver
- •impairment/dysfunction or cirrhosis irrespective of liver enzyme levels.
- •9. Previously demonstrated clinically significant allergy or hypersensitivity to any of the excipients of the investigational medication (TMC114/RTV).
- •EXTENSION PART OF THE TRIAL
- •1. Use of disallowed concomitant therapy;
- •2. Pregnant or breast-feeding female;
- •3. Female of childbearing potential without the use of effective birth control methods from screening until at least 30 days after the end of the treatment period;
- •4. Any active or unstable medical condition or findings during physical examination that, in the investigator’s opinion, would compromise the subject’s safety.
研究者
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