EUCTR2008-006158-16-GB进行中（未招募）1 期
Study on Pharmacokinetics of newly developed ANtiretroviral agents in HIV-infected pregNAnt women (PANNA) - PANNA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
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. HIV-infected as documented by positive HIV antibody test and confirmed by an antigen test.
- •2. Subject is at least 18 years of age at screening.
- •3. Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.
- •4. Treated with an HAART regimen containing at least one agent which is mentioned in Appendix 1; this agent has been taken for at least 2 weeks before the day of first PK curve evaluation.
- •5. Subject is pregnant
- •6. Subject is able to adhere to food intake recommendations.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 2
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 150
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
- •2. Inability to understand the nature and extent of the study and the procedures required.
- •3. Presence of grade III/IV anemia (i.e. Hb <4.6 mmol/L or <7.4 g/dL)
研究者
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