EUCTR2004-001246-33-AT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: 2004年10月19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
- 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
- •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 (except for emtricitabine [FTC], fos-amprenavir,
- •tipranavir, T-20 and atazanavir where approval status may vary from country to country), 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 following 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 (e.g., TB, cardiac dysfunction, pancreatitis,
- •acute viral infections) or findings during physical examination that, in the investigator’s opinion, would compromise the subject’s safety.
研究者
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