EUCTR2011-004435-31-PL进行中（未招募）1 期
An Expanded Access Protocol for Subjects Who HaveCompleted Clinical Studies Involving Maraviroc. - Expanded Access Protocol
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 162
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. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
- •2. Subject has participated in a clinical trial that evaluated maraviroc and is continuing to derive clinical benefit from maraviroc treatment.
- •3. Subject must agree to use an acceptable method of contraception for the duration of the study as outlined at the end of the inclusion criteria.
- •4. Subject agrees to the specified study procedures
- •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 152
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1. Subject who is an investigational site staff member or an employee of the Sponsor that is directly involved in the conduct of the trial.
- •2. Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
- •3. Contra-indications to use of maraviroc as described in the Investigator Brochure.
- •4. Past documented dual/mixed or C-X-C chemokine receptor type 4 HIV tropism.
研究者
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