NL-OMON54597招募中4 期
Study on Pharmacokinetics of newly developed ANtiretroviral agents in HIV-infected pregNAnt women (PANNA) - PANNA
Apotheek Klinische Farmacie0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 0 至 64（—）
入选标准
- •1. HIV-infected as documented by positive HIV antibody test and confirmed by
- •Western Blot.
- •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. Duration of pregnancy not longer than 33 weeks at the day of screening
- •6. Subject is able to adhere to food intake recommendations.
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)
- •4. Using oral cabotegravir/rilpivirine.
研究者
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